{"protocolSection":{"identificationModule":{"nctId":"NCT03548935","orgStudyIdInfo":{"id":"NN9536-4373"},"secondaryIdInfos":[{"id":"U1111-1200-8053","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2017-003436-36","type":"REGISTRY","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":"STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity","officialTitle":"Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity","acronym":"STEP 1"},"statusModule":{"statusVerifiedDate":"2021-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-06-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-03-30","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-05","type":"ACTUAL"},"studyFirstSubmitDate":"2018-05-25","studyFirstSubmitQcDate":"2018-05-25","studyFirstPostDateStruct":{"date":"2018-06-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-06-16","resultsFirstSubmitQcDate":"2021-07-20","resultsFirstPostDateStruct":{"date":"2021-08-11","type":"ACTUAL"},"dispFirstSubmitDate":"2021-03-03","dispFirstSubmitQcDate":"2021-07-20","dispFirstPostDateStruct":{"date":"2021-08-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-11-18","lastUpdatePostDateStruct":{"date":"2021-11-19","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 participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking \"dummy\" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or \"dummy\" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor."},"conditionsModule":{"conditions":["Metabolism and Nutrition Disorder","Overweight or Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1961,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide s.c. 2.4 mg once weekly","type":"EXPERIMENTAL","description":"Participants will receive semaglutide for 68 weeks.","interventionNames":["Drug: Semaglutide"]},{"label":"Semaglutide placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive semaglutide matching placebo for 68 weeks.","interventionNames":["Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.","armGroupLabels":["Semaglutide s.c. 2.4 mg once weekly"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.","armGroupLabels":["Semaglutide placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight (%)","description":"Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.","timeFrame":"After week 68"}],"secondaryOutcomes":[{"measure":"Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).","timeFrame":"Week 68"},{"measure":"Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Week 68"},{"measure":"Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Week 68"},{"measure":"Change in Waist Circumference (cm)","description":"Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Systolic Blood Pressure (mmHg)","description":"Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Short Form 36 (SF-36)","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 eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. 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. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score","description":"IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Weight (kg)","description":"Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Mass Index (BMI) (kg/m2)","description":"Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in HbA1C (%)","description":"Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in HbA1C (mmol/Mol)","description":"Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Fasting Plasma Glucose (FPG) (mg/dL)","description":"Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline","description":"Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Diastolic Blood Pressure (mmHg)","description":"Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Total Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline","description":"Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline","description":"Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline","description":"Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Free Fatty Acids (mg/dL) - Ratio to Baseline","description":"Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Triglycerides (mg/dL) - Ratio to Baseline","description":"Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline","description":"Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline","description":"Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline","description":"Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Leptin (ng/mL) - Ratio to Baseline","description":"Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Composition (Total Fat Mass) (%)","description":"Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Composition (Total Fat Mass) (kg)","description":"Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Composition (Lean Body Mass) (%)","description":"Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Composition (Lean Body Mass) (kg)","description":"Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Composition (Visceral Fat Mass) (%)","description":"Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Composition (Visceral Fat Mass) (kg)","description":"Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Weight (%) - DEXA Subpopulation","description":"Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Weight (kg) - DEXA Subpopulation","description":"Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve \"Responder Definition Value\" (Yes/no) 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 different 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 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 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 is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","timeFrame":"After week 68"},{"measure":"Participants Who Achieve \"Responder Definition Value\" (Yes/no) 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. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","timeFrame":"After week 68"},{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 75"},{"measure":"Number of Serious Adverse Events (SAEs)","description":"A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 75"},{"measure":"Change in Pulse","description":"Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Amylase - Ratio to Baseline","description":"Change in amylase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Lipase - Ratio to Baseline","description":"Change in lipase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Calcitonin - Ratio to Baseline","description":"Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","timeFrame":"Baseline (week 0) to week 68"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nMain phase:\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 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExtension phase:\n\n* Informed consent for the extension phase obtained before any trial related activities for the extension phase\n* On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo\n\nExclusion Criteria:\n\nMain phase:\n\n* Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n\nExtension phase:\n\n* Female who is pregnant or intends to become pregnant during the extension phase\n* Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial","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":"Anniston","state":"Alabama","zip":"36207","country":"United States","geoPoint":{"lat":33.65983,"lon":-85.83163}},{"facility":"Novo Nordisk Investigational Site","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Novo Nordisk Investigational Site","city":"Lomita","state":"California","zip":"90717","country":"United States","geoPoint":{"lat":33.79224,"lon":-118.31507}},{"facility":"Novo Nordisk Investigational Site","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"Novo Nordisk Investigational Site","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Novo Nordisk Investigational Site","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"Novo Nordisk Investigational Site","city":"Chiefland","state":"Florida","zip":"32626","country":"United States","geoPoint":{"lat":29.47496,"lon":-82.85984}},{"facility":"Novo Nordisk Investigational Site","city":"Crystal River","state":"Florida","zip":"34429","country":"United States","geoPoint":{"lat":28.90248,"lon":-82.5926}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32205","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Ocala","state":"Florida","zip":"34470","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"Novo Nordisk Investigational Site","city":"Panama City","state":"Florida","zip":"32401","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":"33567185","type":"RESULT","citation":"Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10."},{"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":"39316288","type":"DERIVED","citation":"Kral P, Holst-Hansen T, Olivieri AV, Ivanescu C, Lamotte M, Larsen S. The Correlation Between Body Mass Index and Health-Related Quality of Life: Data from Two Weight Loss Intervention Studies. Adv Ther. 2024 Nov;41(11):4228-4247. doi: 10.1007/s12325-024-02932-8. Epub 2024 Sep 24."},{"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":"36876594","type":"DERIVED","citation":"McGowan BM, Houshmand-Oeregaard A, Laursen PN, Zeuthen N, Baker-Knight J. Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. Obesity (Silver Spring). 2023 Apr;31(4):990-999. doi: 10.1002/oby.23732. Epub 2023 Mar 6."},{"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":"36200477","type":"DERIVED","citation":"Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28."},{"pmid":"35724304","type":"DERIVED","citation":"Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785."},{"pmid":"35441470","type":"DERIVED","citation":"Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19."},{"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://novonordisk-trials.com/sharing-results"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.","recruitmentDetails":"The trial was conducted at 129 sites in 16 countries as follows (all sites screened and randomized): Argentina (5 sites), Belgium (5 sites), Bulgaria (5 sites), Canada (7 sites), Denmark (1 site), Finland (2 sites), France (7 sites), Germany (13 sites), India (13 sites), Japan (5 sites), Mexico (3 sites), Poland (4 sites), Russian Federation (8 sites), Taiwan(1 site), UK (10 sites), US (40 sites).","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"FG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1306"},{"groupId":"FG001","numSubjects":"655"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"1306"},{"groupId":"FG001","numSubjects":"655"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"1306"},{"groupId":"FG001","numSubjects":"655"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1240"},{"groupId":"FG001","numSubjects":"609"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"66"},{"groupId":"FG001","numSubjects":"46"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomized participants.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"BG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1306"},{"groupId":"BG001","value":"655"},{"groupId":"BG002","value":"1961"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46","spread":"13"},{"groupId":"BG001","value":"47","spread":"12"},{"groupId":"BG002","value":"46","spread":"13"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"955"},{"groupId":"BG001","value":"498"},{"groupId":"BG002","value":"1453"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"351"},{"groupId":"BG001","value":"157"},{"groupId":"BG002","value":"508"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"150"},{"groupId":"BG001","value":"86"},{"groupId":"BG002","value":"236"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1118"},{"groupId":"BG001","value":"551"},{"groupId":"BG002","value":"1669"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"56"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"27"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"181"},{"groupId":"BG001","value":"80"},{"groupId":"BG002","value":"261"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"72"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"111"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"973"},{"groupId":"BG001","value":"499"},{"groupId":"BG002","value":"1472"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"33"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"55"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Weight (%)","description":"Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","populationDescription":"Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1306"},{"groupId":"OG001","value":"655"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-15.6","spread":"10.1"},{"groupId":"OG001","value":"-2.8","spread":"6.5"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1059"},{"groupId":"OG001","value":"499"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-16.9","spread":"9.4"},{"groupId":"OG001","value":"-3.1","spread":"6.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-12.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.37","ciUpperLimit":"-11.51"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-14.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.29","ciUpperLimit":"-13.55"}]},{"type":"PRIMARY","title":"Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up. It excludes any period of temporary treatment interruption.","populationDescription":"Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1306"},{"groupId":"OG001","value":"655"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"1047"},{"groupId":"OG001","value":"182"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"395"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1059"},{"groupId":"OG001","value":"499"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"978"},{"groupId":"OG001","value":"165"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"334"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"11.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.88","ciUpperLimit":"14.19"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"37.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"28.02","ciUpperLimit":"48.95"}]},{"type":"SECONDARY","title":"Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"838"},{"groupId":"OG001","value":"69"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"374"},{"groupId":"OG001","value":"508"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"612"},{"groupId":"OG001","value":"28"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"600"},{"groupId":"OG001","value":"549"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"388"},{"groupId":"OG001","value":"10"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"824"},{"groupId":"OG001","value":"567"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference (cm)","description":"Change in waist circumference from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1210"},{"groupId":"OG001","value":"575"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.1","spread":"9.6"},{"groupId":"OG001","value":"-4.4","spread":"6.9"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure (mmHg)","description":"Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1210"},{"groupId":"OG001","value":"574"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7","spread":"14"},{"groupId":"OG001","value":"-1","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form 36 (SF-36)","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 eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population. 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. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1195"},{"groupId":"OG001","value":"566"}]}],"classes":[{"title":"Change in physical functioning score (SF-36)","categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"6.6"},{"groupId":"OG001","value":"0.4","spread":"7.4"}]}]},{"title":"Change in SF-36 (role-physical score)","categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"7.2"},{"groupId":"OG001","value":"-0.2","spread":"7.2"}]}]},{"title":"Change in SF-36 (bodily pain score)","categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"8.2"},{"groupId":"OG001","value":"-1.3","spread":"8.9"}]}]},{"title":"Change in SF-36 (general health score)","categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"7.2"},{"groupId":"OG001","value":"-0.6","spread":"7.1"}]}]},{"title":"Change in SF-36 (vitality score)","categories":[{"measurements":[{"groupId":"OG000","value":"0.7","spread":"8.0"},{"groupId":"OG001","value":"-1.3","spread":"7.9"}]}]},{"title":"Change in SF-36 (social functioning score)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"6.6"},{"groupId":"OG001","value":"-1.4","spread":"7.4"}]}]},{"title":"Change in SF-36 (role-emotional score)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"7.3"},{"groupId":"OG001","value":"-1.5","spread":"7.6"}]}]},{"title":"Change in SF-36 (mental health score)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"7.0"},{"groupId":"OG001","value":"-1.7","spread":"7.4"}]}]},{"title":"Change in SF-36 (physical component summary)","categories":[{"measurements":[{"groupId":"OG000","value":"2.4","spread":"6.7"},{"groupId":"OG001","value":"0.2","spread":"7.1"}]}]},{"title":"Change in SF-36 (mental component summary)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"7.1"},{"groupId":"OG001","value":"-2.1","spread":"7.7"}]}]}]},{"type":"SECONDARY","title":"Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score","description":"IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1193"},{"groupId":"OG001","value":"566"}]}],"classes":[{"title":"Change in physical function domain score","categories":[{"measurements":[{"groupId":"OG000","value":"15.0","spread":"21.6"},{"groupId":"OG001","value":"6.0","spread":"21.1"}]}]},{"title":"Change in physical domain score","categories":[{"measurements":[{"groupId":"OG000","value":"14.0","spread":"20.0"},{"groupId":"OG001","value":"5.0","spread":"19.5"}]}]},{"title":"Change in psychosocial domain score","categories":[{"measurements":[{"groupId":"OG000","value":"17.4","spread":"19.2"},{"groupId":"OG001","value":"6.9","spread":"17.8"}]}]},{"title":"Change in total score","categories":[{"measurements":[{"groupId":"OG000","value":"16.2","spread":"17.8"},{"groupId":"OG001","value":"6.3","spread":"16.8"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)","description":"Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.1","spread":"10.6"},{"groupId":"OG001","value":"-2.9","spread":"7.2"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index (BMI) (kg/m2)","description":"Change in body mass index from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"Overall number of participants analyzed = full analysis set (FAS) which comprised all randomized participants. Number Analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram per square meter (kg/sqm)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1212"},{"groupId":"OG001","value":"577"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.8","spread":"3.8"},{"groupId":"OG001","value":"-1.0","spread":"2.5"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1C (%)","description":"Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1197"},{"groupId":"OG001","value":"563"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.3"},{"groupId":"OG001","value":"-0.2","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1C (mmol/Mol)","description":"Change in HbA1c from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1197"},{"groupId":"OG001","value":"563"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.1","spread":"3.3"},{"groupId":"OG001","value":"-1.8","spread":"3.0"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (FPG) (mg/dL)","description":"Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1175"},{"groupId":"OG001","value":"557"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.2","spread":"10.9"},{"groupId":"OG001","value":"-0.4","spread":"12.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline","description":"Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline. Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting serum insulin","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1147"},{"groupId":"OG001","value":"550"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.73","spread":"62.3"},{"groupId":"OG001","value":"0.92","spread":"56.5"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure (mmHg)","description":"Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeters of mercury (mmHg)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1210"},{"groupId":"OG001","value":"574"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"9"},{"groupId":"OG001","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1196"},{"groupId":"OG001","value":"561"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"14.8"},{"groupId":"OG001","value":"1.00","spread":"15.5"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline","description":"Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1192"},{"groupId":"OG001","value":"558"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"16.1"},{"groupId":"OG001","value":"1.02","spread":"14.9"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline","description":"Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1194"},{"groupId":"OG001","value":"561"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"23.7"},{"groupId":"OG001","value":"1.01","spread":"25.5"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline","description":"Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1193"},{"groupId":"OG001","value":"561"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"37.7"},{"groupId":"OG001","value":"0.92","spread":"35.2"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids (mg/dL) - Ratio to Baseline","description":"Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1154"},{"groupId":"OG001","value":"552"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.83","spread":"78.3"},{"groupId":"OG001","value":"0.93","spread":"70.8"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (mg/dL) - Ratio to Baseline","description":"Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1194"},{"groupId":"OG001","value":"561"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"38.3"},{"groupId":"OG001","value":"0.92","spread":"36.2"}]}]}]},{"type":"SECONDARY","title":"Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline","description":"Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = 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 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1200"},{"groupId":"OG001","value":"562"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.45","spread":"128.2"},{"groupId":"OG001","value":"0.84","spread":"102.5"}]}]}]},{"type":"SECONDARY","title":"Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline","description":"Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of PAI-1","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1131"},{"groupId":"OG001","value":"546"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.15","spread":"86.5"},{"groupId":"OG001","value":"1.53","spread":"77.3"}]}]}]},{"type":"SECONDARY","title":"Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline","description":"Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of soluble leptin receptor","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1194"},{"groupId":"OG001","value":"562"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.07","spread":"24.9"},{"groupId":"OG001","value":"1.02","spread":"22.2"}]}]}]},{"type":"SECONDARY","title":"Change in Leptin (ng/mL) - Ratio to Baseline","description":"Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of leptin","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1197"},{"groupId":"OG001","value":"563"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.52","spread":"75.9"},{"groupId":"OG001","value":"0.87","spread":"52.7"}]}]}]},{"type":"SECONDARY","title":"Change in Body Composition (Total Fat Mass) (%)","description":"Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.9","spread":"5.4"},{"groupId":"OG001","value":"-0.3","spread":"2.8"}]}]}]},{"type":"SECONDARY","title":"Change in Body Composition (Total Fat Mass) (kg)","description":"Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA). The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.3","spread":"8.5"},{"groupId":"OG001","value":"-1.5","spread":"5.1"}]}]}]},{"type":"SECONDARY","title":"Change in Body Composition (Lean Body Mass) (%)","description":"Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.4","spread":"5.1"},{"groupId":"OG001","value":"0.2","spread":"2.7"}]}]}]},{"type":"SECONDARY","title":"Change in Body Composition (Lean Body Mass) (kg)","description":"Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.8","spread":"4.6"},{"groupId":"OG001","value":"-1.8","spread":"2.5"}]}]}]},{"type":"SECONDARY","title":"Change in Body Composition (Visceral Fat Mass) (%)","description":"Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.2","spread":"4.4"},{"groupId":"OG001","value":"-0.1","spread":"4.5"}]}]}]},{"type":"SECONDARY","title":"Change in Body Composition (Visceral Fat Mass) (kg)","description":"Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented. Body composition was assessed using DEXA. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.3"},{"groupId":"OG001","value":"-0.1","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (%) - DEXA Subpopulation","description":"Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.8","spread":"11.1"},{"groupId":"OG001","value":"-3.4","spread":"6.1"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg) - DEXA Subpopulation","description":"Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).","populationDescription":"DEXA analysis set (DXA) includes participants in the sub-population of FAS that have had a DEXA scan performed at baseline. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.5","spread":"11.4"},{"groupId":"OG001","value":"-3.2","spread":"6.1"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve \"Responder Definition Value\" (Yes/no) 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 different 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 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 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 is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1195"},{"groupId":"OG001","value":"566"}]}],"classes":[{"title":"Yes (with threshold 4.3)","categories":[{"measurements":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"97"}]}]},{"title":"No (with threshold 4.3)","categories":[{"measurements":[{"groupId":"OG000","value":"877"},{"groupId":"OG001","value":"469"}]}]},{"title":"Yes (with threshold 3.7)","categories":[{"measurements":[{"groupId":"OG000","value":"478"},{"groupId":"OG001","value":"153"}]}]},{"title":"No (with threshold 3.7)","categories":[{"measurements":[{"groupId":"OG000","value":"717"},{"groupId":"OG001","value":"413"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve \"Responder Definition Value\" (Yes/no) 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. In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","populationDescription":"FAS included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1193"},{"groupId":"OG001","value":"566"}]}],"classes":[{"title":"Yes (with threshold 20)","categories":[{"measurements":[{"groupId":"OG000","value":"473"},{"groupId":"OG001","value":"145"}]}]},{"title":"No (with threshold 20)","categories":[{"measurements":[{"groupId":"OG000","value":"720"},{"groupId":"OG001","value":"421"}]}]},{"title":"Yes (with threshold 14.6)","categories":[{"measurements":[{"groupId":"OG000","value":"611"},{"groupId":"OG001","value":"186"}]}]},{"title":"No (with threshold 14.6)","categories":[{"measurements":[{"groupId":"OG000","value":"582"},{"groupId":"OG001","value":"380"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Baseline (week 0) to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1306"},{"groupId":"OG001","value":"655"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9658"},{"groupId":"OG001","value":"3302"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (SAEs)","description":"A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 75 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Baseline (week 0) to week 75","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1306"},{"groupId":"OG001","value":"655"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"53"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline (week 0) to week 68","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1059"},{"groupId":"OG001","value":"499"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3","spread":"10"},{"groupId":"OG001","value":"-1","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase - Ratio to Baseline","description":"Change in amylase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of 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 were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1053"},{"groupId":"OG001","value":"497"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.14","spread":"21.6"},{"groupId":"OG001","value":"1.03","spread":"21.4"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase - Ratio to Baseline","description":"Change in lipase (measured as units per litre \\[U/L\\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of 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 were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1053"},{"groupId":"OG001","value":"496"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.41","spread":"49.3"},{"groupId":"OG001","value":"0.97","spread":"37.3"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin - Ratio to Baseline","description":"Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product. Overall number of participants analyzed = number of 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 were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1050"},{"groupId":"OG001","value":"497"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"37.6"},{"groupId":"OG001","value":"0.95","spread":"40.9"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.","description":"All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks.","eventGroups":[{"id":"EG000","title":"Sema 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. 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