{"protocolSection":{"identificationModule":{"nctId":"NCT03552757","orgStudyIdInfo":{"id":"NN9536-4374"},"secondaryIdInfos":[{"id":"U1111-1200-8148","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2017-003414-10","type":"OTHER","domain":"European Medicines Agency (EudraCT)"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity","officialTitle":"Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes","acronym":"STEP 2"},"statusModule":{"statusVerifiedDate":"2021-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-06-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-03-24","type":"ACTUAL"},"completionDateStruct":{"date":"2020-05-01","type":"ACTUAL"},"studyFirstSubmitDate":"2018-05-30","studyFirstSubmitQcDate":"2018-05-30","studyFirstPostDateStruct":{"date":"2018-06-12","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-06-16","resultsFirstSubmitQcDate":"2021-07-20","resultsFirstPostDateStruct":{"date":"2021-08-11","type":"ACTUAL"},"dispFirstSubmitDate":"2021-03-11","dispFirstSubmitQcDate":"2021-07-20","dispFirstPostDateStruct":{"date":"2021-08-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-11-08","lastUpdatePostDateStruct":{"date":"2021-11-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking \"dummy\" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or \"dummy\" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years"},"conditionsModule":{"conditions":["Obesity","Overweight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1210,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 1.0 mg","type":"EXPERIMENTAL","description":"Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.","interventionNames":["Drug: Semaglutide 1.0 mg","Drug: Placebo I (Semaglutide)"]},{"label":"Semaglutide 2.4 mg","type":"EXPERIMENTAL","description":"Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.","interventionNames":["Drug: Semaglutide 2.4 mg","Drug: Placebo II (Semaglutide)"]},{"label":"Semaglutide placebo I/II","type":"PLACEBO_COMPARATOR","description":"Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.","interventionNames":["Drug: Placebo I (Semaglutide)","Drug: Placebo II (Semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide 1.0 mg","description":"Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.","armGroupLabels":["Semaglutide 1.0 mg"]},{"type":"DRUG","name":"Semaglutide 2.4 mg","description":"Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.","armGroupLabels":["Semaglutide 2.4 mg"]},{"type":"DRUG","name":"Placebo I (Semaglutide)","description":"S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.","armGroupLabels":["Semaglutide 1.0 mg","Semaglutide placebo I/II"]},{"type":"DRUG","name":"Placebo II (Semaglutide)","description":"S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.","armGroupLabels":["Semaglutide 2.4 mg","Semaglutide placebo I/II"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo","description":"Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo","description":"Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","timeFrame":"At week 68"}],"secondaryOutcomes":[{"measure":"Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg","description":"Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg","description":"Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Weight (Kg)","description":"Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in BMI","description":"Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%","description":"Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%","description":"Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%","description":"Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Change in HbA1c (%)","description":"Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in HbA1c (mmol/Mol)","description":"Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in FPG (mg/dL)","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Fasting Serum Insulin","description":"Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)","description":"Number of participants who achieved HbA1c \\<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)","description":"Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%","description":"Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%","description":"Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"At week 68"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Total Cholesterol","description":"Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in HDL Cholesterol","description":"Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in LDL Cholesterol","description":"Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in VLDL Cholesterol","description":"Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Free Fatty Acids","description":"Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Triglycerides","description":"Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in hsCRP","description":"Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in PAI-1 Activity","description":"Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in SF-36 (All Scores Except Physical Functioning)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)","description":"The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in IWQOL-Lite for CT (All Scores Except Physical Function)","description":"The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score","description":"The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, \"Yes\" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and \"No\" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","timeFrame":"At week 68"},{"measure":"Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score","description":"The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, \"Yes\" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and \"No\" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","timeFrame":"At week 68"},{"measure":"Number of TEAEs - Semaglutide 2.4 mg Versus Placebo","description":"Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.","timeFrame":"Week 0 to week 75"},{"measure":"Number of SAEs - Semaglutide 2.4 mg Versus Placebo","description":"Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.","timeFrame":"Week 0 to week 75"},{"measure":"Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo","description":"Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","timeFrame":"Week 0 to week 75"},{"measure":"Change in Pulse - Semaglutide 2.4 mg Versus Placebo","description":"Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Amylase - Semaglutide 2.4 mg Versus Placebo","description":"Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Lipase - Semaglutide 2.4 mg Versus Placebo","description":"Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo","description":"Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","timeFrame":"Baseline (week 0) to week 68"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Body Mass Index (BMI) greater than or equal to 27 kg/m\\^2 '\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n* Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening\n\nExclusion Criteria:\n\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m\\^2 (less than 60 ml/min/1.73 m\\^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Buena Park","state":"California","zip":"90620","country":"United States","geoPoint":{"lat":33.86751,"lon":-117.99812}},{"facility":"Novo Nordisk Investigational Site","city":"Concord","state":"California","zip":"94520","country":"United States","geoPoint":{"lat":37.97798,"lon":-122.03107}},{"facility":"Novo Nordisk Investigational Site","city":"Fresno","state":"California","zip":"93720","country":"United 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Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794."},{"pmid":"33667417","type":"RESULT","citation":"Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2."},{"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":"39226070","type":"DERIVED","citation":"Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A. Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials. JAMA Intern Med. 2024 Nov 1;184(11):1290-1300. doi: 10.1001/jamainternmed.2024.4346."},{"pmid":"38698650","type":"DERIVED","citation":"Rubino D, Bjorner JB, Rathor N, Sharma AM, von Huth Smith L, Wharton S, Wadden T, Zeuthen N, Kolotkin RL. Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials. Diabetes Obes Metab. 2024 Jul;26(7):2945-2955. doi: 10.1111/dom.15620. Epub 2024 May 2."},{"pmid":"36801984","type":"DERIVED","citation":"Heerspink HJL, Apperloo E, Davies M, Dicker D, Kandler K, Rosenstock J, Sorrig R, Lawson J, Zeuthen N, Cherney D. Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. Diabetes Care. 2023 Apr 1;46(4):801-810. doi: 10.2337/dc22-1889."},{"pmid":"30122305","type":"DERIVED","citation":"O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://www.novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in 1:1:1 ratio to receive either 'semaglutide 2.4 milligram (mg) and placebo II (placebo matched to semaglutide 1.0 mg) once weekly', 'semaglutide 1.0 mg and placebo I (placebo matched to semaglutide 2.4 mg) once weekly' or 'placebo I and placebo II once weekly'.","recruitmentDetails":"The trial was conducted at 149 sites in 12 countries as follows: Argentina (5 sites), Canada (10 sites), Germany (9 sites), Greece (6 sites), India (18 sites), Japan (12 sites), Russian Federation (9 sites), South Africa (6 sites), Spain (8 sites), United Arab Emirates (5 sites), United Kingdom (10 sites) and United States (51 sites).","groups":[{"id":"FG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly subcutaneous (s.c; under the skin) semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"FG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"FG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"403"},{"groupId":"FG001","numSubjects":"404"},{"groupId":"FG002","numSubjects":"403"}]},{"type":"Exposed","achievements":[{"groupId":"FG000","numSubjects":"402"},{"groupId":"FG001","numSubjects":"403"},{"groupId":"FG002","numSubjects":"402"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"403"},{"groupId":"FG001","numSubjects":"404"},{"groupId":"FG002","numSubjects":"403"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"402"},{"groupId":"FG001","numSubjects":"403"},{"groupId":"FG002","numSubjects":"402"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"390"},{"groupId":"FG001","numSubjects":"391"},{"groupId":"FG002","numSubjects":"383"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"20"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) which comprised all randomised participants.","groups":[{"id":"BG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"BG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"BG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"403"},{"groupId":"BG001","value":"404"},{"groupId":"BG002","value":"403"},{"groupId":"BG003","value":"1210"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Year","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56","spread":"10"},{"groupId":"BG001","value":"55","spread":"11"},{"groupId":"BG002","value":"55","spread":"11"},{"groupId":"BG003","value":"55","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"203"},{"groupId":"BG001","value":"223"},{"groupId":"BG002","value":"190"},{"groupId":"BG003","value":"616"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"200"},{"groupId":"BG001","value":"181"},{"groupId":"BG002","value":"213"},{"groupId":"BG003","value":"594"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"272"},{"groupId":"BG001","value":"237"},{"groupId":"BG002","value":"242"},{"groupId":"BG003","value":"751"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"112"},{"groupId":"BG002","value":"108"},{"groupId":"BG003","value":"317"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"100"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"35"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"6"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Not Applicable","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"344"},{"groupId":"BG001","value":"357"},{"groupId":"BG002","value":"354"},{"groupId":"BG003","value":"1055"}]},{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"59"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"49"},{"groupId":"BG003","value":"155"}]},{"title":"Not Applicable","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo","description":"Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","populationDescription":"Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of body weight","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"403"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"388"},{"groupId":"OG001","value":"376"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.9","spread":"8.0"},{"groupId":"OG001","value":"-3.3","spread":"5.5"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"340"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.7","spread":"7.8"},{"groupId":"OG001","value":"-3.1","spread":"5.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-6.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.28","ciUpperLimit":"-5.15"},{"groupIds":["OG000","OG001"],"groupDescription":"Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM","paramType":"Treatment difference","paramValue":"-7.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.56","ciUpperLimit":"-6.58"}]},{"type":"PRIMARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo","description":"Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","populationDescription":"Overall number of participants analysed = FAS which comprised all randomised participants. Number analysed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"403"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"388"},{"groupId":"OG001","value":"376"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"107"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"269"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"340"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"94"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"246"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.58","ciUpperLimit":"6.64"},{"groupIds":["OG000","OG001"],"groupDescription":"Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"8.69","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.31","ciUpperLimit":"11.97"}]},{"type":"SECONDARY","title":"Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg","description":"Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of body weight","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"388"},{"groupId":"OG001","value":"380"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.9","spread":"8.0"},{"groupId":"OG001","value":"-7.2","spread":"6.6"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg","description":"Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"388"},{"groupId":"OG001","value":"380"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"217"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"163"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimetre (cm)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"387"},{"groupId":"OG002","value":"375"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.9","spread":"6.8"},{"groupId":"OG001","value":"-9.7","spread":"8.1"},{"groupId":"OG002","value":"-4.3","spread":"6.5"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (Kg)","description":"Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram (kg)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"388"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.1","spread":"6.7"},{"groupId":"OG001","value":"-9.9","spread":"8.5"},{"groupId":"OG002","value":"-3.4","spread":"6.2"}]}]}]},{"type":"SECONDARY","title":"Change in BMI","description":"Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram per square meter (kg/m^2)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"388"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.6","spread":"2.4"},{"groupId":"OG001","value":"-3.6","spread":"3.1"},{"groupId":"OG002","value":"-1.2","spread":"2.1"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%","description":"Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"388"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"177"},{"groupId":"OG002","value":"31"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"211"},{"groupId":"OG002","value":"345"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%","description":"Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"388"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"12"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"288"},{"groupId":"OG002","value":"364"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%","description":"Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"380"},{"groupId":"OG001","value":"388"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"6"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"362"},{"groupId":"OG001","value":"337"},{"groupId":"OG002","value":"370"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (%)","description":"Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point of HbA1c","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"374"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.1"},{"groupId":"OG001","value":"-1.7","spread":"1.2"},{"groupId":"OG002","value":"-0.3","spread":"1.3"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (mmol/Mol)","description":"Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per mole (mmol/mol)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"374"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.9","spread":"12.3"},{"groupId":"OG001","value":"-18.7","spread":"13.0"},{"groupId":"OG002","value":"-3.4","spread":"14.3"}]}]}]},{"type":"SECONDARY","title":"Change in FPG (mg/dL)","description":"Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"367"},{"groupId":"OG001","value":"375"},{"groupId":"OG002","value":"370"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-36.5","spread":"45.1"},{"groupId":"OG001","value":"-37.9","spread":"45.9"},{"groupId":"OG002","value":"-2.3","spread":"53.1"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Serum Insulin","description":"Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Picomoles per litre (pmol/L)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"352"},{"groupId":"OG001","value":"360"},{"groupId":"OG002","value":"351"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"59.8"},{"groupId":"OG001","value":"0.90","spread":"65.4"},{"groupId":"OG002","value":"0.93","spread":"53.6"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)","description":"Number of participants who achieved HbA1c \\<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"374"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"299"},{"groupId":"OG002","value":"99"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"275"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)","description":"Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"374"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"58"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"316"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%","description":"Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"374"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"170"},{"groupId":"OG002","value":"25"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"211"},{"groupId":"OG002","value":"349"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%","description":"Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \\<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"381"},{"groupId":"OG002","value":"374"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"98"},{"groupId":"OG002","value":"11"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"283"},{"groupId":"OG002","value":"363"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimetre of mercury (mmHg)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"379"},{"groupId":"OG001","value":"387"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"15"},{"groupId":"OG001","value":"-4","spread":"14"},{"groupId":"OG002","value":"0","spread":"15"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimetre of mercury (mmHg)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"379"},{"groupId":"OG001","value":"387"},{"groupId":"OG002","value":"376"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1","spread":"9"},{"groupId":"OG001","value":"-2","spread":"9"},{"groupId":"OG002","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"380"},{"groupId":"OG002","value":"373"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"20.1"},{"groupId":"OG001","value":"0.99","spread":"17.9"},{"groupId":"OG002","value":"1.00","spread":"18.9"}]}]}]},{"type":"SECONDARY","title":"Change in HDL Cholesterol","description":"Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"375"},{"groupId":"OG002","value":"369"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"16.0"},{"groupId":"OG001","value":"1.07","spread":"15.7"},{"groupId":"OG002","value":"1.04","spread":"15.3"}]}]}]},{"type":"SECONDARY","title":"Change in LDL Cholesterol","description":"Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"380"},{"groupId":"OG002","value":"373"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"37.5"},{"groupId":"OG001","value":"1.00","spread":"30.9"},{"groupId":"OG002","value":"1.00","spread":"28.9"}]}]}]},{"type":"SECONDARY","title":"Change in VLDL Cholesterol","description":"Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"380"},{"groupId":"OG002","value":"373"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.82","spread":"42.1"},{"groupId":"OG001","value":"0.80","spread":"42.0"},{"groupId":"OG002","value":"0.92","spread":"40.5"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids","description":"Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"353"},{"groupId":"OG001","value":"361"},{"groupId":"OG002","value":"354"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.85","spread":"61.4"},{"groupId":"OG001","value":"0.84","spread":"68.7"},{"groupId":"OG002","value":"1.01","spread":"62.3"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides","description":"Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"380"},{"groupId":"OG002","value":"373"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.81","spread":"44.5"},{"groupId":"OG001","value":"0.79","spread":"43.8"},{"groupId":"OG002","value":"0.92","spread":"44.5"}]}]}]},{"type":"SECONDARY","title":"Change in hsCRP","description":"Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of hsCRP","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"380"},{"groupId":"OG002","value":"373"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.59","spread":"115.7"},{"groupId":"OG001","value":"0.50","spread":"125.7"},{"groupId":"OG002","value":"0.84","spread":"90.9"}]}]}]},{"type":"SECONDARY","title":"Change in PAI-1 Activity","description":"Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of PAI-1 activity","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"353"},{"groupId":"OG002","value":"336"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.21","spread":"73.7"},{"groupId":"OG001","value":"1.06","spread":"80.8"},{"groupId":"OG002","value":"1.42","spread":"68.9"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"376"},{"groupId":"OG002","value":"365"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"6.8"},{"groupId":"OG001","value":"2.8","spread":"7.7"},{"groupId":"OG002","value":"0.8","spread":"7.0"}]}]}]},{"type":"SECONDARY","title":"Change in SF-36 (All Scores Except Physical Functioning)","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"376"},{"groupId":"OG002","value":"365"}]}],"classes":[{"title":"Role-Physical","categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"6.9"},{"groupId":"OG001","value":"0.8","spread":"7.4"},{"groupId":"OG002","value":"0.0","spread":"7.1"}]}]},{"title":"Bodily Pain","categories":[{"measurements":[{"groupId":"OG000","value":"0.4","spread":"8.3"},{"groupId":"OG001","value":"0.3","spread":"9.0"},{"groupId":"OG002","value":"-0.4","spread":"8.6"}]}]},{"title":"General Health","categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"7.2"},{"groupId":"OG001","value":"2.2","spread":"7.3"},{"groupId":"OG002","value":"0.6","spread":"7.5"}]}]},{"title":"Vitality","categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"7.8"},{"groupId":"OG001","value":"0.8","spread":"7.9"},{"groupId":"OG002","value":"-0.9","spread":"7.9"}]}]},{"title":"Social Functioning","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"6.6"},{"groupId":"OG001","value":"0.2","spread":"6.6"},{"groupId":"OG002","value":"-0.7","spread":"7.4"}]}]},{"title":"Role-Emotional","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"7.3"},{"groupId":"OG001","value":"-0.4","spread":"7.7"},{"groupId":"OG002","value":"-1.1","spread":"7.8"}]}]},{"title":"Mental Health","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"7.5"},{"groupId":"OG001","value":"-0.4","spread":"6.9"},{"groupId":"OG002","value":"-1.6","spread":"7.5"}]}]},{"title":"Physical component summary","categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"6.4"},{"groupId":"OG001","value":"2.3","spread":"7.2"},{"groupId":"OG002","value":"0.9","spread":"6.6"}]}]},{"title":"Mental component summary","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"7.4"},{"groupId":"OG001","value":"-0.9","spread":"6.9"},{"groupId":"OG002","value":"-1.8","spread":"7.6"}]}]}]},{"type":"SECONDARY","title":"Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)","description":"The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"376"},{"groupId":"OG002","value":"365"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.5","spread":"18.8"},{"groupId":"OG001","value":"11.4","spread":"20.8"},{"groupId":"OG002","value":"4.9","spread":"20.4"}]}]}]},{"type":"SECONDARY","title":"Change in IWQOL-Lite for CT (All Scores Except Physical Function)","description":"The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"376"},{"groupId":"OG002","value":"365"}]}],"classes":[{"title":"Physical","categories":[{"measurements":[{"groupId":"OG000","value":"7.6","spread":"18.0"},{"groupId":"OG001","value":"11.0","spread":"19.6"},{"groupId":"OG002","value":"4.4","spread":"19.1"}]}]},{"title":"Psychosocial","categories":[{"measurements":[{"groupId":"OG000","value":"8.6","spread":"15.7"},{"groupId":"OG001","value":"9.6","spread":"16.7"},{"groupId":"OG002","value":"5.6","spread":"16.5"}]}]},{"title":"Total","categories":[{"measurements":[{"groupId":"OG000","value":"8.2","spread":"14.8"},{"groupId":"OG001","value":"10.1","spread":"15.9"},{"groupId":"OG002","value":"5.2","spread":"15.5"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score","description":"The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, \"Yes\" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and \"No\" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"370"},{"groupId":"OG001","value":"376"},{"groupId":"OG002","value":"365"}]}],"classes":[{"title":"Yes (with threshold 4.3)","categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"111"},{"groupId":"OG002","value":"68"}]}]},{"title":"No (with threshold 4.3)","categories":[{"measurements":[{"groupId":"OG000","value":"282"},{"groupId":"OG001","value":"265"},{"groupId":"OG002","value":"297"}]}]},{"title":"Yes (with threshold 3.7)","categories":[{"measurements":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"158"},{"groupId":"OG002","value":"102"}]}]},{"title":"No (with threshold 3.7)","categories":[{"measurements":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"218"},{"groupId":"OG002","value":"263"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score","description":"The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, \"Yes\" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and \"No\" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 68","groups":[{"id":"OG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG002","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"376"},{"groupId":"OG002","value":"365"}]}],"classes":[{"title":"Yes (with threshold 20)","categories":[{"measurements":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"83"}]}]},{"title":"No (with threshold 20)","categories":[{"measurements":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"245"},{"groupId":"OG002","value":"282"}]}]},{"title":"Yes (with threshold 14.6)","categories":[{"measurements":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"113"}]}]},{"title":"No (with threshold 14.6)","categories":[{"measurements":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"216"},{"groupId":"OG002","value":"252"}]}]}]},{"type":"SECONDARY","title":"Number of TEAEs - Semaglutide 2.4 mg Versus Placebo","description":"Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.","populationDescription":"Safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Week 0 to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"402"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2197"},{"groupId":"OG001","value":"1388"}]}]}]},{"type":"SECONDARY","title":"Number of SAEs - Semaglutide 2.4 mg Versus Placebo","description":"Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses.","populationDescription":"SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Week 0 to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"402"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"53"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo","description":"Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.","populationDescription":"SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"Week 0 to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"403"},{"groupId":"OG001","value":"402"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"18"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse - Semaglutide 2.4 mg Versus Placebo","description":"Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","populationDescription":"SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats/minute","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"351"},{"groupId":"OG001","value":"340"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"9"},{"groupId":"OG001","value":"0","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase - Semaglutide 2.4 mg Versus Placebo","description":"Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","populationDescription":"SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"338"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.24","spread":"28.3"},{"groupId":"OG001","value":"1.06","spread":"25.0"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase - Semaglutide 2.4 mg Versus Placebo","description":"Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","populationDescription":"SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"338"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.41","spread":"57.2"},{"groupId":"OG001","value":"0.99","spread":"51.8"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo","description":"Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.","populationDescription":"SAS included all randomised participants exposed to at least one dose of randomised treatment. 'Overall Number of Participants Analysed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of calcitonin","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"348"},{"groupId":"OG001","value":"339"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"60.3"},{"groupId":"OG001","value":"0.96","spread":"38.6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.","description":"All presented AEs are treatment-emergent (i.e., TEAEs).","eventGroups":[{"id":"EG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. 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