{"protocolSection":{"identificationModule":{"nctId":"NCT02970942","orgStudyIdInfo":{"id":"NN9931-4296"},"secondaryIdInfos":[{"id":"2016-000685-39","type":"EUDRACT_NUMBER"},{"id":"U1111-1179-7464","type":"OTHER","domain":"WHO"},{"id":"2016","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2016"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.","officialTitle":"This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis"},"statusModule":{"statusVerifiedDate":"2021-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-11-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-02-13","type":"ACTUAL"},"completionDateStruct":{"date":"2020-03-19","type":"ACTUAL"},"studyFirstSubmitDate":"2016-11-18","studyFirstSubmitQcDate":"2016-11-18","studyFirstPostDateStruct":{"date":"2016-11-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-02-11","resultsFirstSubmitQcDate":"2021-03-25","resultsFirstPostDateStruct":{"date":"2021-04-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-11-15","lastUpdatePostDateStruct":{"date":"2021-11-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis"},"conditionsModule":{"conditions":["Hepatobiliary Disorders","Non-alcoholic Steatohepatitis"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":320,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 0,1 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Semaglutide"]},{"label":"Semaglutide 0,2 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Semaglutide"]},{"label":"Semaglutide 0,4 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo 1","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Placebo 2","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Placebo 3","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)","armGroupLabels":["Semaglutide 0,1 mg","Semaglutide 0,2 mg","Semaglutide 0,4 mg"]},{"type":"DRUG","name":"Placebo","description":"Once daily administration subcutaneously ( s.c., under the skin)","armGroupLabels":["Placebo 1","Placebo 2","Placebo 3"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)","description":"NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"After 72 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)","description":"NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.","timeFrame":"After 72 weeks"},{"measure":"Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)","description":"Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Steatosis","description":"Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Lobular Inflammation","description":"Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Hepatocyte Ballooning","description":"Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification","description":"Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score","description":"Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Fibrosis-4 Score","description":"Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age \\[years\\] x AST \\[U/L\\]) / (platelets \\[10\\^9/L\\] x (square root of ALT \\[U/L\\])). A Fibrosis-4 index of \\< 1.45 indicated no or moderate fibrosis and an index of \\> 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in NAFLD Fibrosis Score (NFS)","description":"Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 \\* age (years) + 0.094 \\* body mass index (BMI) (kg/m\\^2) + 1.13 \\* hyperglycaemia (yes/no) + 0.99 \\* Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (\\*10\\^9/L) - 0.66 \\* albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) \\< -1.5 indicates a low probability, b) \\> -1.5 to \\< 0.67 indicates intermediate probability, and a score of c) \\> 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Alanine Aminotransferase (ALT)","description":"Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Aspartate Aminotransferase (AST)","description":"Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Gamma Glutamyl Transferase (GGT)","description":"Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Albumin","description":"Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in International Normalized Ratio (INR)","description":"Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Enhanced Liver Fibrosis (ELF)","description":"Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) \\< 7.7: no to mild fibrosis; b) ≥ 7.7 - \\< 9.8: Moderate fibrosis; c) ≥ 9.8 - \\< 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Cytokeratin 18 (CK-18) Fragments","description":"Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in microRNA 122 (miR-122)","description":"Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Interleukin-1 Receptor (IL-1R) Antagonist","description":"Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Monocyte Chemoattractant Protein 1 (MCP-1)","description":"Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Fibroblast Growth Factor 21 (FGF-21)","description":"Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Liver Stiffness Assessed by FibroScan®","description":"Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Liver Steatosis Assessed by FibroScan®","description":"Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)","description":"Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).","timeFrame":"Week 72"},{"measure":"Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)","description":"Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).","timeFrame":"Week 72"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Body Mass Index (BMI)","description":"Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Glycosylated Haemoglobin (HbA1c) (%-Point)","description":"Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in HbA1c (Millimoles Per Mole)","description":"Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Fasting Glucagon","description":"Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)","description":"Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose \\[mmol/L\\] x fasting insulin \\[mmol/L\\]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Diastolic Blood Pressure (DBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Systolic Blood Pressure (SBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol","description":"Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Triglycerides","description":"Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Free Fatty Acids","description":"Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in High Sensitivity C-reactive Protein (hsCRP)","description":"Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Short Form 36 (SF-36) Score","description":"Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Treatment-emergent Hypoglycaemic Episodes","description":"Hypoglycaemic episode (blood glucose less than or equal to (\\<=) 3.9 mmol/L (70 mg/dL) Or greater than (\\>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value \\< 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Treatment-emergent Severe Hypoglycaemic Episodes","description":"Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events","description":"Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"From week 0 to week 79"},{"measure":"Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","timeFrame":"From week 0 to week 79"},{"measure":"Change in Pulse From Baseline to Week 72","description":"Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Electrocardiogram (ECG)","description":"A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Cardiovascular System","description":"Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System","description":"Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth","description":"Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: General Appearance","description":"Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck","description":"Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Lymph Node Palpation","description":"Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Musculoskeletal System","description":"Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Respiratory System","description":"Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Skin","description":"Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Percentage of Participants With Change in Physical Examination: Thyroid Gland","description":"Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Week -6, week 72"},{"measure":"Change in Haematocrit","description":"Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Haemoglobin (g/dL)","description":"Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Haemoglobin (mmol/L)","description":"Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Leukocytes","description":"Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Thrombocytes","description":"Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Erythrocytes","description":"Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Creatinine (mg/dL)","description":"Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Creatinine (Umol/L)","description":"Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Estimated Glomerular Filtration Rate (eGFR)","description":"Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m\\^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Creatine Kinase","description":"Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Urea","description":"Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Total Bilirubin (mg/dL)","description":"Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Total Bilirubin (Umol/L)","description":"Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Alkaline Phosphatase","description":"Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Ferritin","description":"Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Sodium (mEq/L)","description":"Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Sodium (mmol/L)","description":"Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Potassium (mEq/L)","description":"Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Potassium (mmol/L)","description":"Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Calcium (mg/dL)","description":"Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Calcium (mmol/L)","description":"Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Amylase","description":"Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Lipase","description":"Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"},{"measure":"Change in Calcitonin","description":"Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","timeFrame":"Baseline (week 0), Week 72"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence\\* or narcotics. (\\* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35233","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Chandler","state":"Arizona","zip":"85224","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"Novo Nordisk Investigational Site","city":"Tucson","state":"Arizona","zip":"85712","country":"United 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A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13."},{"pmid":"40985232","type":"DERIVED","citation":"Nitze LM, Ratziu V, Sanyal AJ, Wong VW, Balendran C, Fleckner J, Skalshoi Kjaer M, Krarup N, Anstee QM. Exploration of Multiple Non-Invasive Tests for Assessing Response to Treatment in a Semaglutide Phase 2b Trial in Patients with MASH. Aliment Pharmacol Ther. 2026 Feb;63(3):396-404. doi: 10.1111/apt.70376. Epub 2025 Sep 23."},{"pmid":"40980163","type":"DERIVED","citation":"Schattenberg JM, Gronbaek H, Kliers I, Ladelund S, Long MT, Nygard SB, Sanyal AJ, Davies MJ. Proteomic signatures reflect effects of semaglutide treatment for MASH. JHEP Rep. 2025 Jul 22;7(10):101521. doi: 10.1016/j.jhepr.2025.101521. eCollection 2025 Oct."},{"pmid":"38112484","type":"DERIVED","citation":"Ratziu V, Francque S, Behling CA, Cejvanovic V, Cortez-Pinto H, Iyer JS, Krarup N, Le Q, Sejling AS, Tiniakos D, Harrison SA. Artificial intelligence scoring of liver biopsies in a phase II trial of semaglutide in nonalcoholic steatohepatitis. Hepatology. 2024 Jul 1;80(1):173-185. doi: 10.1097/HEP.0000000000000723. Epub 2023 Dec 19."},{"pmid":"38058795","type":"DERIVED","citation":"Wai-Sun Wong V, Anstee QM, Nitze LM, Geerts A, George J, Nolasco V, Kjaer MS, Ladelund S, Newsome PN, Ratziu V. FibroScan-aspartate aminotransferase (FAST) score for monitoring histological improvement in non-alcoholic steatohepatitis activity during semaglutide treatment: post-hoc analysis of a randomised, double-blind, placebo-controlled, phase 2b trial. EClinicalMedicine. 2023 Nov 20;66:102310. doi: 10.1016/j.eclinm.2023.102310. eCollection 2023 Dec."},{"pmid":"37328931","type":"DERIVED","citation":"Romero-Gomez M, Armstrong MJ, Funuyet-Salas J, Mangla KK, Ladelund S, Sejling AS, Shrestha I, Sanyal AJ. Improved health-related quality of life with semaglutide in people with non-alcoholic steatohepatitis: A randomised trial. Aliment Pharmacol Ther. 2023 Aug;58(4):395-403. doi: 10.1111/apt.17598. Epub 2023 Jun 16."},{"pmid":"33039693","type":"DERIVED","citation":"Harrison SA, Calanna S, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal A, Sejling AS, Newsome PN. Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. Contemp Clin Trials. 2020 Oct;97:106174. doi: 10.1016/j.cct.2020.106174. Epub 2020 Oct 8."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to Novo Nordisk disclosure commitment on novonordisk.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in a 3:3:3:1:1:1 ratio to receive once-daily semaglutide or placebo subcutaneously. After randomisation, the participants entered a dose-escalation period, with increase in dose every 4 weeks until the target dose was reached.","recruitmentDetails":"The trial was conducted at 114 sites in 16 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Australia (4/ 3); Austria (3/ 3); Belgium (4/ 4); Bulgaria (2/ 2); Canada (9/ 7); Denmark (2/ 2); Finland (1/ 1); France (8/ 6); Greece (5/ 5); Japan (13/ 12); Netherlands (7/ 5); Russian Federation (25/ 17); Spain (6/ 5); Sweden (3/ 2); United Kingdom (15/ 11); United States (36/ 29).","groups":[{"id":"FG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"FG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"FG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"FG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"78"},{"groupId":"FG002","numSubjects":"82"},{"groupId":"FG003","numSubjects":"80"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"78"},{"groupId":"FG002","numSubjects":"82"},{"groupId":"FG003","numSubjects":"80"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"78"},{"groupId":"FG002","numSubjects":"81"},{"groupId":"FG003","numSubjects":"80"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"78"},{"groupId":"FG002","numSubjects":"81"},{"groupId":"FG003","numSubjects":"80"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"76"},{"groupId":"FG001","numSubjects":"72"},{"groupId":"FG002","numSubjects":"77"},{"groupId":"FG003","numSubjects":"77"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set included all randomised participants.","groups":[{"id":"BG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"BG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"BG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"BG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"80"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"82"},{"groupId":"BG003","value":"80"},{"groupId":"BG004","value":"320"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.2","spread":"10.9"},{"groupId":"BG001","value":"58.1","spread":"9.9"},{"groupId":"BG002","value":"54.3","spread":"10.2"},{"groupId":"BG003","value":"52.4","spread":"10.8"},{"groupId":"BG004","value":"55.0","spread":"10.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"47"},{"groupId":"BG003","value":"44"},{"groupId":"BG004","value":"194"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"35"},{"groupId":"BG003","value":"36"},{"groupId":"BG004","value":"126"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"40"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"263"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"17"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"48"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"62"},{"groupId":"BG004","value":"248"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"}]},{"title":"Not applicable","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"17"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)","description":"NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved NASH resolution without worsening of fibrosis and 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"After 72 weeks","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"58"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"40.4"},{"groupId":"OG001","value":"35.6"},{"groupId":"OG002","value":"58.9"},{"groupId":"OG003","value":"17.2"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"54.4"},{"groupId":"OG001","value":"47.5"},{"groupId":"OG002","value":"30.4"},{"groupId":"OG003","value":"74.1"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"5.3"},{"groupId":"OG001","value":"16.9"},{"groupId":"OG002","value":"10.7"},{"groupId":"OG003","value":"8.6"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)","description":"NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with fibrosis stage 2 or 3 at baseline who contributed to the analysis. In below table, 'Yes' infers percentage of participants who achieved at least one stage of fibrosis improvement with no worsening of NASH; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"After 72 weeks","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"58"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"49.1"},{"groupId":"OG001","value":"32.2"},{"groupId":"OG002","value":"42.9"},{"groupId":"OG003","value":"32.8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"45.6"},{"groupId":"OG001","value":"50.8"},{"groupId":"OG002","value":"46.4"},{"groupId":"OG003","value":"58.6"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"5.3"},{"groupId":"OG001","value":"16.9"},{"groupId":"OG002","value":"10.7"},{"groupId":"OG003","value":"8.6"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)","description":"Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Improvement","categories":[{"measurements":[{"groupId":"OG000","value":"71.3"},{"groupId":"OG001","value":"79.5"},{"groupId":"OG002","value":"82.9"},{"groupId":"OG003","value":"43.8"}]}]},{"title":"Worsening","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"2.6"},{"groupId":"OG002","value":"3.7"},{"groupId":"OG003","value":"16.3"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"13.8"},{"groupId":"OG001","value":"5.1"},{"groupId":"OG002","value":"1.2"},{"groupId":"OG003","value":"27.5"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"12.8"},{"groupId":"OG002","value":"12.2"},{"groupId":"OG003","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Steatosis","description":"Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Improvement","categories":[{"measurements":[{"groupId":"OG000","value":"52.5"},{"groupId":"OG001","value":"60.3"},{"groupId":"OG002","value":"63.4"},{"groupId":"OG003","value":"26.3"}]}]},{"title":"Worsening","categories":[{"measurements":[{"groupId":"OG000","value":"6.3"},{"groupId":"OG001","value":"2.6"},{"groupId":"OG002","value":"3.7"},{"groupId":"OG003","value":"15.0"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"33.8"},{"groupId":"OG001","value":"24.4"},{"groupId":"OG002","value":"20.7"},{"groupId":"OG003","value":"46.3"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"12.8"},{"groupId":"OG002","value":"12.2"},{"groupId":"OG003","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Lobular Inflammation","description":"Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Improvement","categories":[{"measurements":[{"groupId":"OG000","value":"41.3"},{"groupId":"OG001","value":"47.4"},{"groupId":"OG002","value":"37.8"},{"groupId":"OG003","value":"26.3"}]}]},{"title":"Worsening","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"7.7"},{"groupId":"OG002","value":"6.1"},{"groupId":"OG003","value":"17.5"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"43.8"},{"groupId":"OG001","value":"32.1"},{"groupId":"OG002","value":"43.9"},{"groupId":"OG003","value":"45.0"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"12.8"},{"groupId":"OG002","value":"12.2"},{"groupId":"OG003","value":"11.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Hepatocyte Ballooning","description":"Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Improvement","categories":[{"measurements":[{"groupId":"OG000","value":"61.3"},{"groupId":"OG001","value":"70.5"},{"groupId":"OG002","value":"74.4"},{"groupId":"OG003","value":"38.8"}]}]},{"title":"Worsening","categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"2.6"},{"groupId":"OG002","value":"1.2"},{"groupId":"OG003","value":"2.5"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"28.8"},{"groupId":"OG001","value":"14.1"},{"groupId":"OG002","value":"12.2"},{"groupId":"OG003","value":"46.3"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"12.8"},{"groupId":"OG002","value":"12.2"},{"groupId":"OG003","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification","description":"Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Improvement","categories":[{"measurements":[{"groupId":"OG000","value":"46.3"},{"groupId":"OG001","value":"32.1"},{"groupId":"OG002","value":"42.7"},{"groupId":"OG003","value":"31.3"}]}]},{"title":"Worsening","categories":[{"measurements":[{"groupId":"OG000","value":"10.0"},{"groupId":"OG001","value":"7.7"},{"groupId":"OG002","value":"4.9"},{"groupId":"OG003","value":"18.8"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"36.3"},{"groupId":"OG001","value":"42.3"},{"groupId":"OG002","value":"36.6"},{"groupId":"OG003","value":"37.5"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"17.9"},{"groupId":"OG002","value":"15.9"},{"groupId":"OG003","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score","description":"Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Improvement","categories":[{"measurements":[{"groupId":"OG000","value":"62.5"},{"groupId":"OG001","value":"71.8"},{"groupId":"OG002","value":"72.0"},{"groupId":"OG003","value":"42.5"}]}]},{"title":"Worsening","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"3.8"},{"groupId":"OG002","value":"1.2"},{"groupId":"OG003","value":"11.3"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"22.5"},{"groupId":"OG001","value":"11.5"},{"groupId":"OG002","value":"14.6"},{"groupId":"OG003","value":"33.8"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"12.8"},{"groupId":"OG002","value":"12.2"},{"groupId":"OG003","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Change in Fibrosis-4 Score","description":"Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age \\[years\\] x AST \\[U/L\\]) / (platelets \\[10\\^9/L\\] x (square root of ALT \\[U/L\\])). A Fibrosis-4 index of \\< 1.45 indicated no or moderate fibrosis and an index of \\> 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fibrosis-4 score","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.81","spread":"36.8"},{"groupId":"OG001","value":"0.77","spread":"32.4"},{"groupId":"OG002","value":"0.77","spread":"31.3"},{"groupId":"OG003","value":"0.95","spread":"43.1"}]}]}]},{"type":"SECONDARY","title":"Change in NAFLD Fibrosis Score (NFS)","description":"Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 \\* age (years) + 0.094 \\* body mass index (BMI) (kg/m\\^2) + 1.13 \\* hyperglycaemia (yes/no) + 0.99 \\* Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (\\*10\\^9/L) - 0.66 \\* albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) \\< -1.5 indicates a low probability, b) \\> -1.5 to \\< 0.67 indicates intermediate probability, and a score of c) \\> 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.322","spread":"0.819"},{"groupId":"OG001","value":"-0.617","spread":"0.691"},{"groupId":"OG002","value":"-0.475","spread":"0.770"},{"groupId":"OG003","value":"-0.040","spread":"0.844"}]}]}]},{"type":"SECONDARY","title":"Change in Alanine Aminotransferase (ALT)","description":"Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ALT","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.62","spread":"62.7"},{"groupId":"OG001","value":"0.57","spread":"62.1"},{"groupId":"OG002","value":"0.40","spread":"68.2"},{"groupId":"OG003","value":"0.80","spread":"60.3"}]}]}]},{"type":"SECONDARY","title":"Change in Aspartate Aminotransferase (AST)","description":"Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of AST","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.66","spread":"55.1"},{"groupId":"OG001","value":"0.63","spread":"46.6"},{"groupId":"OG002","value":"0.50","spread":"45.8"},{"groupId":"OG003","value":"0.84","spread":"62.3"}]}]}]},{"type":"SECONDARY","title":"Change in Gamma Glutamyl Transferase (GGT)","description":"Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of GGT","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"52.0"},{"groupId":"OG001","value":"0.64","spread":"51.6"},{"groupId":"OG002","value":"0.48","spread":"60.2"},{"groupId":"OG003","value":"0.92","spread":"46.6"}]}]}]},{"type":"SECONDARY","title":"Change in Albumin","description":"Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of albumin","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.02","spread":"5.6"},{"groupId":"OG001","value":"1.01","spread":"6.0"},{"groupId":"OG002","value":"1.01","spread":"5.4"},{"groupId":"OG003","value":"1.02","spread":"6.0"}]}]}]},{"type":"SECONDARY","title":"Change in International Normalized Ratio (INR)","description":"Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of INR","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"18.8"},{"groupId":"OG001","value":"0.96","spread":"11.8"},{"groupId":"OG002","value":"0.93","spread":"22.3"},{"groupId":"OG003","value":"0.99","spread":"19.3"}]}]}]},{"type":"SECONDARY","title":"Change in Enhanced Liver Fibrosis (ELF)","description":"Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) \\< 7.7: no to mild fibrosis; b) ≥ 7.7 - \\< 9.8: Moderate fibrosis; c) ≥ 9.8 - \\< 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.7"},{"groupId":"OG001","value":"-0.4","spread":"0.8"},{"groupId":"OG002","value":"-0.6","spread":"0.8"},{"groupId":"OG003","value":"0.1","spread":"0.7"}]}]}]},{"type":"SECONDARY","title":"Change in Cytokeratin 18 (CK-18) Fragments","description":"Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of CK-18 fragments","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"74"}]}],"classes":[{"title":"M30","categories":[{"measurements":[{"groupId":"OG000","value":"0.52","spread":"84.2"},{"groupId":"OG001","value":"0.50","spread":"76.4"},{"groupId":"OG002","value":"0.40","spread":"74.5"},{"groupId":"OG003","value":"0.78","spread":"106.9"}]}]},{"title":"M65","categories":[{"measurements":[{"groupId":"OG000","value":"0.51","spread":"73.1"},{"groupId":"OG001","value":"0.52","spread":"62.5"},{"groupId":"OG002","value":"0.38","spread":"65.6"},{"groupId":"OG003","value":"0.71","spread":"83.7"}]}]}]},{"type":"SECONDARY","title":"Change in microRNA 122 (miR-122)","description":"Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of miR-122","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"151.8"},{"groupId":"OG001","value":"0.74","spread":"203.1"},{"groupId":"OG002","value":"0.58","spread":"161.3"},{"groupId":"OG003","value":"1.28","spread":"194.3"}]}]}]},{"type":"SECONDARY","title":"Change in Interleukin-1 Receptor (IL-1R) Antagonist","description":"Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of IL-1R antagonist","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"69"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.87","spread":"49.3"},{"groupId":"OG001","value":"0.85","spread":"37.5"},{"groupId":"OG002","value":"0.73","spread":"47.9"},{"groupId":"OG003","value":"0.94","spread":"41.7"}]}]}]},{"type":"SECONDARY","title":"Change in Monocyte Chemoattractant Protein 1 (MCP-1)","description":"Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of MCP-1","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"23.3"},{"groupId":"OG001","value":"1.08","spread":"29.8"},{"groupId":"OG002","value":"0.99","spread":"30.7"},{"groupId":"OG003","value":"1.04","spread":"26.4"}]}]}]},{"type":"SECONDARY","title":"Change in Fibroblast Growth Factor 21 (FGF-21)","description":"Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of FGF-21","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"86.1"},{"groupId":"OG001","value":"0.61","spread":"104.1"},{"groupId":"OG002","value":"0.55","spread":"91.3"},{"groupId":"OG003","value":"0.76","spread":"64.8"}]}]}]},{"type":"SECONDARY","title":"Change in Liver Stiffness Assessed by FibroScan®","description":"Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of liver stiffness","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"45"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"49.3"},{"groupId":"OG001","value":"0.64","spread":"52.2"},{"groupId":"OG002","value":"0.66","spread":"58.4"},{"groupId":"OG003","value":"1.18","spread":"71.2"}]}]}]},{"type":"SECONDARY","title":"Change in Liver Steatosis Assessed by FibroScan®","description":"Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Decibels per meter","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.8","spread":"41.1"},{"groupId":"OG001","value":"-50.9","spread":"64.3"},{"groupId":"OG002","value":"-42.1","spread":"73.3"},{"groupId":"OG003","value":"-18.7","spread":"43.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)","description":"Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"43.8"},{"groupId":"OG001","value":"62.8"},{"groupId":"OG002","value":"76.8"},{"groupId":"OG003","value":"16.3"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"51.3"},{"groupId":"OG001","value":"28.2"},{"groupId":"OG002","value":"17.1"},{"groupId":"OG003","value":"78.8"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"5.0"},{"groupId":"OG001","value":"9.0"},{"groupId":"OG002","value":"6.1"},{"groupId":"OG003","value":"5.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)","description":"Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).","populationDescription":"Full analysis set included all randomised participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"17.5"},{"groupId":"OG001","value":"38.5"},{"groupId":"OG002","value":"59.8"},{"groupId":"OG003","value":"2.5"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"77.5"},{"groupId":"OG001","value":"52.6"},{"groupId":"OG002","value":"34.1"},{"groupId":"OG003","value":"92.5"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"OG000","value":"5.0"},{"groupId":"OG001","value":"9.0"},{"groupId":"OG002","value":"6.1"},{"groupId":"OG003","value":"5.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.8","spread":"6.0"},{"groupId":"OG001","value":"-9.4","spread":"9.2"},{"groupId":"OG002","value":"-12.3","spread":"8.6"},{"groupId":"OG003","value":"-1.0","spread":"4.9"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeters","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"6.3"},{"groupId":"OG001","value":"-7.1","spread":"8.9"},{"groupId":"OG002","value":"-11.4","spread":"9.3"},{"groupId":"OG003","value":"-1.7","spread":"6.2"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index (BMI)","description":"Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms per square meter","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"2.2"},{"groupId":"OG001","value":"-3.5","spread":"3.4"},{"groupId":"OG002","value":"-4.6","spread":"3.3"},{"groupId":"OG003","value":"-0.3","spread":"1.8"}]}]}]},{"type":"SECONDARY","title":"Change in Glycosylated Haemoglobin (HbA1c) (%-Point)","description":"Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"1.1"},{"groupId":"OG001","value":"-1.2","spread":"0.9"},{"groupId":"OG002","value":"-1.2","spread":"1.0"},{"groupId":"OG003","value":"-0.0","spread":"1.0"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (Millimoles Per Mole)","description":"Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per mole","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.9","spread":"12.2"},{"groupId":"OG001","value":"-12.8","spread":"9.5"},{"groupId":"OG002","value":"-12.8","spread":"11.3"},{"groupId":"OG003","value":"-0.3","spread":"10.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG)","description":"Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimoles per liter","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.39","spread":"2.53"},{"groupId":"OG001","value":"-2.17","spread":"1.82"},{"groupId":"OG002","value":"-2.09","spread":"2.68"},{"groupId":"OG003","value":"-0.34","spread":"2.72"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Glucagon","description":"Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of glucagon","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.78","spread":"76.8"},{"groupId":"OG001","value":"0.65","spread":"94.8"},{"groupId":"OG002","value":"0.63","spread":"100.4"},{"groupId":"OG003","value":"1.04","spread":"80.8"}]}]}]},{"type":"SECONDARY","title":"Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)","description":"Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose \\[mmol/L\\] x fasting insulin \\[mmol/L\\]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HOMA-IR","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"44"},{"groupId":"OG003","value":"45"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"62.2"},{"groupId":"OG001","value":"0.60","spread":"77.6"},{"groupId":"OG002","value":"0.58","spread":"94.6"},{"groupId":"OG003","value":"0.81","spread":"127.5"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure (DBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"10"},{"groupId":"OG001","value":"-2","spread":"11"},{"groupId":"OG002","value":"-2","spread":"9"},{"groupId":"OG003","value":"-1","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure (SBP)","description":"Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"16"},{"groupId":"OG001","value":"-7","spread":"18"},{"groupId":"OG002","value":"-6","spread":"16"},{"groupId":"OG003","value":"-2","spread":"15"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants.Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"17.1"},{"groupId":"OG001","value":"1.00","spread":"20.3"},{"groupId":"OG002","value":"0.93","spread":"15.7"},{"groupId":"OG003","value":"0.93","spread":"18.8"}]}]}]},{"type":"SECONDARY","title":"Change in Low Density Lipoprotein (LDL) Cholesterol","description":"Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"22.9"},{"groupId":"OG001","value":"1.01","spread":"34.9"},{"groupId":"OG002","value":"0.92","spread":"25.5"},{"groupId":"OG003","value":"0.90","spread":"30.7"}]}]}]},{"type":"SECONDARY","title":"Change in High Density Lipoprotein (HDL) Cholesterol","description":"Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"16.1"},{"groupId":"OG001","value":"1.05","spread":"12.9"},{"groupId":"OG002","value":"1.09","spread":"16.4"},{"groupId":"OG003","value":"1.01","spread":"12.9"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol","description":"Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.89","spread":"31.9"},{"groupId":"OG001","value":"0.90","spread":"36.1"},{"groupId":"OG002","value":"0.74","spread":"38.2"},{"groupId":"OG003","value":"0.93","spread":"36.7"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides","description":"Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.88","spread":"34.1"},{"groupId":"OG001","value":"0.89","spread":"37.6"},{"groupId":"OG002","value":"0.73","spread":"41.4"},{"groupId":"OG003","value":"0.95","spread":"36.9"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids","description":"Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"74"},{"groupId":"OG003","value":"72"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.83","spread":"54.8"},{"groupId":"OG001","value":"0.92","spread":"73.2"},{"groupId":"OG002","value":"0.72","spread":"80.8"},{"groupId":"OG003","value":"1.05","spread":"75.9"}]}]}]},{"type":"SECONDARY","title":"Change in High Sensitivity C-reactive Protein (hsCRP)","description":"Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of hsCRP","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.78","spread":"114.6"},{"groupId":"OG001","value":"0.50","spread":"124.1"},{"groupId":"OG002","value":"0.41","spread":"114.6"},{"groupId":"OG003","value":"0.91","spread":"85.8"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 (SF-36) Score","description":"Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Mental component sum","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"8.5"},{"groupId":"OG001","value":"0.6","spread":"9.2"},{"groupId":"OG002","value":"1.2","spread":"9.5"},{"groupId":"OG003","value":"-0.4","spread":"8.9"}]}]},{"title":"Physical component sum","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"7.0"},{"groupId":"OG001","value":"1.1","spread":"7.3"},{"groupId":"OG002","value":"3.9","spread":"7.1"},{"groupId":"OG003","value":"-0.1","spread":"8.3"}]}]},{"title":"Physical functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"76"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"7.8"},{"groupId":"OG001","value":"2.0","spread":"7.3"},{"groupId":"OG002","value":"2.8","spread":"7.8"},{"groupId":"OG003","value":"-0.4","spread":"8.2"}]}]},{"title":"Role functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"6.9"},{"groupId":"OG001","value":"0.5","spread":"9.3"},{"groupId":"OG002","value":"2.2","spread":"8.1"},{"groupId":"OG003","value":"-0.3","spread":"9.4"}]}]},{"title":"Bodily pain","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"10.9"},{"groupId":"OG001","value":"1.2","spread":"10.1"},{"groupId":"OG002","value":"3.4","spread":"7.9"},{"groupId":"OG003","value":"-1.3","spread":"10.2"}]}]},{"title":"General health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.2","spread":"14.8"},{"groupId":"OG001","value":"2.3","spread":"17.8"},{"groupId":"OG002","value":"9.0","spread":"17.4"},{"groupId":"OG003","value":"4.3","spread":"16.5"}]}]},{"title":"Vitality","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"8.6"},{"groupId":"OG001","value":"0.6","spread":"9.4"},{"groupId":"OG002","value":"4.6","spread":"9.8"},{"groupId":"OG003","value":"-0.2","spread":"10.1"}]}]},{"title":"Social functioning","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.7","spread":"9.0"},{"groupId":"OG001","value":"-0.1","spread":"9.9"},{"groupId":"OG002","value":"2.2","spread":"9.4"},{"groupId":"OG003","value":"-1.6","spread":"8.3"}]}]},{"title":"Role emotional","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"8.9"},{"groupId":"OG001","value":"0.6","spread":"9.1"},{"groupId":"OG002","value":"0.5","spread":"9.5"},{"groupId":"OG003","value":"-0.3","spread":"8.5"}]}]},{"title":"Mental health","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.2","spread":"8.9"},{"groupId":"OG001","value":"1.5","spread":"8.2"},{"groupId":"OG002","value":"1.3","spread":"9.5"},{"groupId":"OG003","value":"-0.2","spread":"9.7"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"525"},{"groupId":"OG001","value":"577"},{"groupId":"OG002","value":"511"},{"groupId":"OG003","value":"445"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Hypoglycaemic Episodes","description":"Hypoglycaemic episode (blood glucose less than or equal to (\\<=) 3.9 mmol/L (70 mg/dL) Or greater than (\\>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"18"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes","description":"Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value \\< 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"2"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Severe Hypoglycaemic Episodes","description":"Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"episodes","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events","description":"Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"79"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)","description":"Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From week 0 to week 79","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse From Baseline to Week 72","description":"Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2","spread":"10.9"},{"groupId":"OG001","value":"2.1","spread":"9.0"},{"groupId":"OG002","value":"0.9","spread":"9.6"},{"groupId":"OG003","value":"-0.3","spread":"9.1"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Electrocardiogram (ECG)","description":"A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week 0: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"58.8"},{"groupId":"OG001","value":"60.3"},{"groupId":"OG002","value":"66.7"},{"groupId":"OG003","value":"63.8"}]}]},{"title":"Week 0: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"41.3"},{"groupId":"OG001","value":"39.7"},{"groupId":"OG002","value":"32.1"},{"groupId":"OG003","value":"36.3"}]}]},{"title":"Week 0: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"1.2"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"64.9"},{"groupId":"OG001","value":"65.1"},{"groupId":"OG002","value":"74.6"},{"groupId":"OG003","value":"60.0"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"35.1"},{"groupId":"OG001","value":"34.9"},{"groupId":"OG002","value":"23.9"},{"groupId":"OG003","value":"38.6"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"1.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Cardiovascular System","description":"Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"87.5"},{"groupId":"OG001","value":"93.6"},{"groupId":"OG002","value":"92.6"},{"groupId":"OG003","value":"92.5"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"5.1"},{"groupId":"OG002","value":"7.4"},{"groupId":"OG003","value":"6.3"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"1.3"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.3"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"87.8"},{"groupId":"OG001","value":"96.9"},{"groupId":"OG002","value":"94.4"},{"groupId":"OG003","value":"90.1"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"12.2"},{"groupId":"OG001","value":"3.1"},{"groupId":"OG002","value":"5.6"},{"groupId":"OG003","value":"8.5"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System","description":"Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"92.5"},{"groupId":"OG001","value":"94.8"},{"groupId":"OG002","value":"98.7"},{"groupId":"OG003","value":"95.0"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.0"},{"groupId":"OG001","value":"5.2"},{"groupId":"OG002","value":"1.3"},{"groupId":"OG003","value":"3.8"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.3"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"94.6"},{"groupId":"OG001","value":"93.7"},{"groupId":"OG002","value":"98.6"},{"groupId":"OG003","value":"92.9"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.4"},{"groupId":"OG001","value":"4.8"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"7.1"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"1.6"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth","description":"Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"82.5"},{"groupId":"OG001","value":"83.1"},{"groupId":"OG002","value":"84.0"},{"groupId":"OG003","value":"86.3"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.8"},{"groupId":"OG001","value":"15.6"},{"groupId":"OG002","value":"16.0"},{"groupId":"OG003","value":"12.5"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.8"},{"groupId":"OG001","value":"1.3"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.3"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"89.2"},{"groupId":"OG001","value":"81.0"},{"groupId":"OG002","value":"87.5"},{"groupId":"OG003","value":"84.5"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10.8"},{"groupId":"OG001","value":"19.0"},{"groupId":"OG002","value":"12.5"},{"groupId":"OG003","value":"14.1"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: General Appearance","description":"Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"83.8"},{"groupId":"OG001","value":"85.9"},{"groupId":"OG002","value":"79.0"},{"groupId":"OG003","value":"80.0"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.3"},{"groupId":"OG001","value":"12.8"},{"groupId":"OG002","value":"21.0"},{"groupId":"OG003","value":"20.0"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"1.3"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"83.8"},{"groupId":"OG001","value":"90.6"},{"groupId":"OG002","value":"90.3"},{"groupId":"OG003","value":"76.1"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.2"},{"groupId":"OG001","value":"6.3"},{"groupId":"OG002","value":"9.7"},{"groupId":"OG003","value":"23.9"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"3.1"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck","description":"Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"97.5"},{"groupId":"OG001","value":"94.8"},{"groupId":"OG002","value":"98.8"},{"groupId":"OG003","value":"97.5"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"5.2"},{"groupId":"OG002","value":"1.3"},{"groupId":"OG003","value":"2.5"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"94.5"},{"groupId":"OG001","value":"96.8"},{"groupId":"OG002","value":"98.6"},{"groupId":"OG003","value":"98.6"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"},{"groupId":"OG001","value":"3.2"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Lymph Node Palpation","description":"Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"78"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"78"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"98.7"},{"groupId":"OG002","value":"100.0"},{"groupId":"OG003","value":"100.0"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"78"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"1.3"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"78"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"100.0"},{"groupId":"OG002","value":"100.0"},{"groupId":"OG003","value":"100.0"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Musculoskeletal System","description":"Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"95.0"},{"groupId":"OG001","value":"96.1"},{"groupId":"OG002","value":"94.9"},{"groupId":"OG003","value":"95.0"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.8"},{"groupId":"OG001","value":"3.9"},{"groupId":"OG002","value":"5.1"},{"groupId":"OG003","value":"3.8"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.3"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"94.6"},{"groupId":"OG001","value":"96.8"},{"groupId":"OG002","value":"100.0"},{"groupId":"OG003","value":"95.8"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.4"},{"groupId":"OG001","value":"3.2"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"4.2"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Respiratory System","description":"Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"100.0"},{"groupId":"OG002","value":"100.0"},{"groupId":"OG003","value":"97.5"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"2.5"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"98.6"},{"groupId":"OG001","value":"96.9"},{"groupId":"OG002","value":"98.6"},{"groupId":"OG003","value":"98.6"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"3.1"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"1.4"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Skin","description":"Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"96.3"},{"groupId":"OG001","value":"92.3"},{"groupId":"OG002","value":"85.2"},{"groupId":"OG003","value":"90.0"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"6.4"},{"groupId":"OG002","value":"13.6"},{"groupId":"OG003","value":"10.0"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"81"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"1.3"},{"groupId":"OG002","value":"1.2"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"94.6"},{"groupId":"OG001","value":"87.5"},{"groupId":"OG002","value":"90.0"},{"groupId":"OG003","value":"88.7"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.1"},{"groupId":"OG001","value":"10.9"},{"groupId":"OG002","value":"8.6"},{"groupId":"OG003","value":"11.3"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.4"},{"groupId":"OG001","value":"1.6"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With Change in Physical Examination: Thyroid Gland","description":"Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week -6, week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"classes":[{"title":"Week -6: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"88.8"},{"groupId":"OG001","value":"97.4"},{"groupId":"OG002","value":"97.5"},{"groupId":"OG003","value":"98.8"}]}]},{"title":"Week -6: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10.0"},{"groupId":"OG001","value":"2.6"},{"groupId":"OG002","value":"2.5"},{"groupId":"OG003","value":"0.0"}]}]},{"title":"Week -6: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"1.3"}]}]},{"title":"Week 72: Normal","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"94.6"},{"groupId":"OG001","value":"98.4"},{"groupId":"OG002","value":"97.1"},{"groupId":"OG003","value":"98.6"}]}]},{"title":"Week 72: Abnormal NCS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.4"},{"groupId":"OG001","value":"1.6"},{"groupId":"OG002","value":"2.9"},{"groupId":"OG003","value":"1.4"}]}]},{"title":"Week 72: Abnormal CS","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"}]}]}]},{"type":"SECONDARY","title":"Change in Haematocrit","description":"Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of haematocrit in blood","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.79","spread":"3.14"},{"groupId":"OG001","value":"-0.71","spread":"2.77"},{"groupId":"OG002","value":"-1.43","spread":"3.50"},{"groupId":"OG003","value":"-0.41","spread":"3.53"}]}]}]},{"type":"SECONDARY","title":"Change in Haemoglobin (g/dL)","description":"Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Grams per deciliter (g/dL)","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.18","spread":"1.05"},{"groupId":"OG001","value":"0.08","spread":"0.89"},{"groupId":"OG002","value":"-0.07","spread":"0.98"},{"groupId":"OG003","value":"0.21","spread":"1.08"}]}]}]},{"type":"SECONDARY","title":"Change in Haemoglobin (mmol/L)","description":"Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.11","spread":"0.65"},{"groupId":"OG001","value":"0.05","spread":"0.55"},{"groupId":"OG002","value":"-0.05","spread":"0.61"},{"groupId":"OG003","value":"0.13","spread":"0.67"}]}]}]},{"type":"SECONDARY","title":"Change in Leukocytes","description":"Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells per liter (10^9/L)","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.489","spread":"1.564"},{"groupId":"OG001","value":"0.260","spread":"1.343"},{"groupId":"OG002","value":"-0.047","spread":"1.532"},{"groupId":"OG003","value":"0.075","spread":"1.733"}]}]}]},{"type":"SECONDARY","title":"Change in Thrombocytes","description":"Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^9 cells per liter (10^9/L)","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"67"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.8","spread":"46.9"},{"groupId":"OG001","value":"14.6","spread":"34.8"},{"groupId":"OG002","value":"9.0","spread":"44.9"},{"groupId":"OG003","value":"0.3","spread":"43.7"}]}]}]},{"type":"SECONDARY","title":"Change in Erythrocytes","description":"Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^12 cells per liter (10^12/L)","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"70"},{"groupId":"OG003","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.038","spread":"0.292"},{"groupId":"OG001","value":"0.004","spread":"0.220"},{"groupId":"OG002","value":"-0.034","spread":"0.334"},{"groupId":"OG003","value":"0.054","spread":"0.314"}]}]}]},{"type":"SECONDARY","title":"Change in Creatinine (mg/dL)","description":"Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of creatinine","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.018","spread":"30.70"},{"groupId":"OG001","value":"1.069","spread":"42.19"},{"groupId":"OG002","value":"1.026","spread":"35.17"},{"groupId":"OG003","value":"1.021","spread":"33.87"}]}]}]},{"type":"SECONDARY","title":"Change in Creatinine (Umol/L)","description":"Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of creatinine","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.018","spread":"30.70"},{"groupId":"OG001","value":"1.069","spread":"42.19"},{"groupId":"OG002","value":"1.026","spread":"35.17"},{"groupId":"OG003","value":"1.021","spread":"33.87"}]}]}]},{"type":"SECONDARY","title":"Change in Estimated Glomerular Filtration Rate (eGFR)","description":"Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m\\^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of eGFR","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.976","spread":"28.04"},{"groupId":"OG001","value":"0.940","spread":"40.47"},{"groupId":"OG002","value":"0.973","spread":"31.42"},{"groupId":"OG003","value":"0.969","spread":"31.24"}]}]}]},{"type":"SECONDARY","title":"Change in Creatine Kinase","description":"Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of creatine kinase","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.975","spread":"73.02"},{"groupId":"OG001","value":"0.798","spread":"77.96"},{"groupId":"OG002","value":"0.825","spread":"74.17"},{"groupId":"OG003","value":"0.904","spread":"76.04"}]}]}]},{"type":"SECONDARY","title":"Change in Urea","description":"Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of urea","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.018","spread":"51.01"},{"groupId":"OG001","value":"0.973","spread":"52.30"},{"groupId":"OG002","value":"1.042","spread":"51.14"},{"groupId":"OG003","value":"1.043","spread":"52.30"}]}]}]},{"type":"SECONDARY","title":"Change in Total Bilirubin (mg/dL)","description":"Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total bilirubin","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.978","spread":"66.72"},{"groupId":"OG001","value":"1.011","spread":"70.66"},{"groupId":"OG002","value":"0.949","spread":"65.89"},{"groupId":"OG003","value":"1.040","spread":"67.36"}]}]}]},{"type":"SECONDARY","title":"Change in Total Bilirubin (Umol/L)","description":"Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total bilirubin","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.978","spread":"66.72"},{"groupId":"OG001","value":"1.011","spread":"70.66"},{"groupId":"OG002","value":"0.949","spread":"65.89"},{"groupId":"OG003","value":"1.040","spread":"67.36"}]}]}]},{"type":"SECONDARY","title":"Change in Alkaline Phosphatase","description":"Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of alkaline phosphatase","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.980","spread":"45.68"},{"groupId":"OG001","value":"0.931","spread":"43.59"},{"groupId":"OG002","value":"0.884","spread":"54.90"},{"groupId":"OG003","value":"0.992","spread":"42.42"}]}]}]},{"type":"SECONDARY","title":"Change in Ferritin","description":"Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of ferritin","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.660","spread":"99.95"},{"groupId":"OG001","value":"0.617","spread":"88.70"},{"groupId":"OG002","value":"0.603","spread":"88.83"},{"groupId":"OG003","value":"0.713","spread":"96.91"}]}]}]},{"type":"SECONDARY","title":"Change in Sodium (mEq/L)","description":"Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of sodium","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.999","spread":"12.23"},{"groupId":"OG001","value":"1.000","spread":"12.13"},{"groupId":"OG002","value":"1.002","spread":"11.68"},{"groupId":"OG003","value":"1.002","spread":"12.91"}]}]}]},{"type":"SECONDARY","title":"Change in Sodium (mmol/L)","description":"Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of sodium","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.999","spread":"12.23"},{"groupId":"OG001","value":"1.000","spread":"12.13"},{"groupId":"OG002","value":"1.002","spread":"11.68"},{"groupId":"OG003","value":"1.002","spread":"12.91"}]}]}]},{"type":"SECONDARY","title":"Change in Potassium (mEq/L)","description":"Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of potassium","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"69"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.004","spread":"27.00"},{"groupId":"OG001","value":"0.979","spread":"29.36"},{"groupId":"OG002","value":"0.998","spread":"27.81"},{"groupId":"OG003","value":"0.998","spread":"27.78"}]}]}]},{"type":"SECONDARY","title":"Change in Potassium (mmol/L)","description":"Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of potassium","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"69"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.004","spread":"27.00"},{"groupId":"OG001","value":"0.979","spread":"29.36"},{"groupId":"OG002","value":"0.998","spread":"27.81"},{"groupId":"OG003","value":"0.998","spread":"27.78"}]}]}]},{"type":"SECONDARY","title":"Change in Calcium (mg/dL)","description":"Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcium","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.017","spread":"20.37"},{"groupId":"OG001","value":"1.018","spread":"20.49"},{"groupId":"OG002","value":"1.008","spread":"20.88"},{"groupId":"OG003","value":"1.010","spread":"22.79"}]}]}]},{"type":"SECONDARY","title":"Change in Calcium (mmol/L)","description":"Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcium","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.017","spread":"20.37"},{"groupId":"OG001","value":"1.018","spread":"20.49"},{"groupId":"OG002","value":"1.008","spread":"20.88"},{"groupId":"OG003","value":"1.010","spread":"22.79"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase","description":"Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.155","spread":"49.85"},{"groupId":"OG001","value":"1.120","spread":"65.01"},{"groupId":"OG002","value":"1.170","spread":"47.88"},{"groupId":"OG003","value":"1.051","spread":"45.74"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase","description":"Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.305","spread":"77.43"},{"groupId":"OG001","value":"1.245","spread":"87.68"},{"groupId":"OG002","value":"1.375","spread":"73.88"},{"groupId":"OG003","value":"1.003","spread":"66.72"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin","description":"Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.","populationDescription":"Safety analysis set included all participants who received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Calcitonin","timeFrame":"Baseline (week 0), Week 72","groups":[{"id":"OG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72)."},{"id":"OG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72)."},{"id":"OG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72)."},{"id":"OG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"62"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"70"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.040","spread":"62.98"},{"groupId":"OG001","value":"0.937","spread":"65.42"},{"groupId":"OG002","value":"1.000","spread":"66.24"},{"groupId":"OG003","value":"0.950","spread":"62.39"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From week 0 to week 79 Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.","description":"All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.","eventGroups":[{"id":"EG000","title":"Semaglutide 0.1 mg","description":"Participants were to receive once daily subcutaneous (s.c.) injection of semaglutide for 72 weeks. Participants initially received 0.05 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.1 mg was reached: 0.05 mg (week 1 to week 4) and 0.1 mg (week 5 to week 72).","deathsNumAffected":0,"deathsNumAtRisk":80,"seriousNumAffected":12,"seriousNumAtRisk":80,"otherNumAffected":61,"otherNumAtRisk":80},{"id":"EG001","title":"Semaglutide 0.2 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.2 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8) and 0.2 mg (week 9 to week 72).","deathsNumAffected":1,"deathsNumAtRisk":78,"seriousNumAffected":15,"seriousNumAtRisk":78,"otherNumAffected":64,"otherNumAtRisk":78},{"id":"EG002","title":"Semaglutide 0.4 mg","description":"Participants were to receive once daily s.c. injection of semaglutide for 72 weeks. Participants initially received 0.05 mg of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 0.4 mg was reached: 0.05 mg (week 1 to week 4), 0.1 mg (week 5 to week 8), 0.2 mg (week 9 to week 12), 0.3 mg (week 13 to week 16) and 0.4 mg (week 17 to week 72).","deathsNumAffected":0,"deathsNumAtRisk":81,"seriousNumAffected":12,"seriousNumAtRisk":81,"otherNumAffected":63,"otherNumAtRisk":81},{"id":"EG003","title":"Placebo","description":"Participants were to receive once daily s.c. injection of placebo matched to semaglutide (0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg) for 72 weeks.","deathsNumAffected":0,"deathsNumAtRisk":80,"seriousNumAffected":8,"seriousNumAtRisk":80,"otherNumAffected":55,"otherNumAtRisk":80}],"seriousEvents":[{"term":"Abdominal adhesions","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":78},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":81},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":80}]},{"term":"Acute kidney injury","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":78},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":81},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":80}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":78},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":81},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":80}]},{"term":"Anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":80},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":78},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":81},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":80}]},{"term":"Anal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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