{"protocolSection":{"identificationModule":{"nctId":"NCT03611582","orgStudyIdInfo":{"id":"NN9536-4375"},"secondaryIdInfos":[{"id":"U1111-1200-8199","type":"OTHER","domain":"World Health Organization (WHO)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program","officialTitle":"Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity","acronym":"STEP 3"},"statusModule":{"statusVerifiedDate":"2021-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-08-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-03-18","type":"ACTUAL"},"completionDateStruct":{"date":"2020-04-28","type":"ACTUAL"},"studyFirstSubmitDate":"2018-07-17","studyFirstSubmitQcDate":"2018-08-01","studyFirstPostDateStruct":{"date":"2018-08-02","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-06-16","resultsFirstSubmitQcDate":"2021-06-16","resultsFirstPostDateStruct":{"date":"2021-07-09","type":"ACTUAL"},"dispFirstSubmitDate":"2021-03-03","dispFirstSubmitQcDate":"2021-03-03","dispFirstPostDateStruct":{"date":"2021-03-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-11-10","lastUpdatePostDateStruct":{"date":"2021-11-11","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 participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking \"dummy\" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or \"dummy\" medicine - which treatment the participant gets is decided by chance. The participant 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. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor."},"conditionsModule":{"conditions":["Overweight","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":611,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Participants will receive semaglutide 2.4 mg during 68-week treatment period in addition to intensive behavioural therapy.","interventionNames":["Drug: Semaglutide"]},{"label":"Semaglutide placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.","interventionNames":["Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 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 periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: 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 (Yes/no): Body Weight Reduction More Than or Equal to 5%","description":"Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. 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 68 weeks"}],"secondaryOutcomes":[{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%","description":"Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. 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":"After 68 weeks"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%","description":"Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. 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":"After 68 weeks"},{"measure":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%","description":"Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. 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":"After 68 weeks"},{"measure":"Change in Waist Circumference","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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Systolic Blood Pressure","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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Short Form-36 (SF-36) - Physical Functioning Score","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomisation (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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Body Mass Index","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 randomisation (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 randomisation (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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose from 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Fasting Serum Insulin","description":"Change in fasting serum insulin from week 0 to week 68 \\[measured as milli-international units per milliliter (mIU/mL)\\] 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Total Cholesterol","description":"Change in fasting total cholesterol from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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)","description":"Change in fasting HDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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)","description":"Change in fasting LDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Very Low Density Lipoprotein (VLDL)","description":"Change in fasting VLDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Free Fatty Acids","description":"Change in fasting free fatty acids from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Change in Triglycerides","description":"Change in fasting triglycerides from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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","description":"Change in high sensitivity C-reactive protein 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 randomisation (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 Activity","description":"Change in plasminogen activator inhibitor-1 activity 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 68"},{"measure":"Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score","description":"The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, \"Yes\" infers 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 uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","timeFrame":"After 68 weeks"},{"measure":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to week 8 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 randomisation (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Baseline (week 0) to week 8"},{"measure":"Number of Treatment-emergent Adverse Events (AEs)","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 that had onset date (or increase in severity) on or after the first day of exposure to treatment. 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","description":"Change in amylase (measured as 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","description":"Change in lipase (measured as 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","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\n* Male or female, age more than or equal to 18 years at the time of signing informed consent\n* Body mass index more than or equal to 30 kg/m\\^2 or more than or equal to 27 kg/m\\^2 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\nExclusion Criteria:\n\n* Hemoglobin A1c more 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 more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records","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":"Birmingham","state":"Alabama","zip":"35294","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Montgomery","state":"Alabama","zip":"36106","country":"United States","geoPoint":{"lat":32.36681,"lon":-86.29997}},{"facility":"Novo Nordisk Investigational Site","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"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 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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":"33625476","type":"RESULT","citation":"Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831."},{"pmid":"39226070","type":"DERIVED","citation":"Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A. Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials. JAMA Intern Med. 2024 Nov 1;184(11):1290-1300. doi: 10.1001/jamainternmed.2024.4346."},{"pmid":"38698650","type":"DERIVED","citation":"Rubino D, Bjorner JB, Rathor N, Sharma AM, von Huth Smith L, Wharton S, Wadden T, Zeuthen N, Kolotkin RL. Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials. Diabetes Obes Metab. 2024 Jul;26(7):2945-2955. doi: 10.1111/dom.15620. Epub 2024 May 2."},{"pmid":"36801984","type":"DERIVED","citation":"Heerspink HJL, Apperloo E, Davies M, Dicker D, Kandler K, Rosenstock J, Sorrig R, Lawson J, Zeuthen N, Cherney D. Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. Diabetes Care. 2023 Apr 1;46(4):801-810. doi: 10.2337/dc22-1889."},{"pmid":"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":"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"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial has a 68-week treatment period (16 weeks of dose escalation and 52 weeks of maintenance dose). Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo.","recruitmentDetails":"The trial was conducted in 41 sites in the United States.","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"FG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"407"},{"groupId":"FG001","numSubjects":"204"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"407"},{"groupId":"FG001","numSubjects":"204"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"407"},{"groupId":"FG001","numSubjects":"204"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"339"},{"groupId":"FG001","numSubjects":"166"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"38"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"At the discretion of the investigator","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Safety concern as judged by the investigator","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"other","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"16"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"BG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"407"},{"groupId":"BG001","value":"204"},{"groupId":"BG002","value":"611"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46","spread":"13"},{"groupId":"BG001","value":"46","spread":"13"},{"groupId":"BG002","value":"46","spread":"13"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"315"},{"groupId":"BG001","value":"180"},{"groupId":"BG002","value":"495"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"116"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"121"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"332"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"490"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"11"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"80"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"116"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"307"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"465"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"15"}]}]}]}]},"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 periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: 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","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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"407"},{"groupId":"OG001","value":"204"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-16.5","spread":"10.1"},{"groupId":"OG001","value":"-5.8","spread":"7.7"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"164"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-17.6","spread":"9.6"},{"groupId":"OG001","value":"-6.1","spread":"7.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-10.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.97","ciUpperLimit":"-8.57"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM (mixed model repeated measurement)","paramType":"Treatment difference","paramValue":"-12.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.34","ciUpperLimit":"-11.00"}]},{"type":"PRIMARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%","description":"Number of participants who achieved greater than or equal to (≥) 5% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. 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 68 weeks","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"407"},{"groupId":"OG001","value":"204"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"90"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"99"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"164"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"82"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"82"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"6.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.04","ciUpperLimit":"9.26"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM (mixed model repeated measurement)","paramType":"Odds Ratio (OR)","paramValue":"11.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.64","ciUpperLimit":"17.81"}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%","description":"Number of participants who achieved greater than or equal to (≥) 10% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. 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":"After 68 weeks","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"51"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"138"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%","description":"Number of participants who achieved greater than or equal to (≥) 15% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. 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":"After 68 weeks","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"25"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"164"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%","description":"Number of participants who achieved greater than or equal to (≥) 20% weight loss after 68 weeks is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 20% weight loss whereas 'No' infers number of participants who have not achieved ≥ 20% weight loss. 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":"After 68 weeks","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"7"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"182"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"371"},{"groupId":"OG001","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.2","spread":"10.2"},{"groupId":"OG001","value":"-6.1","spread":"8.6"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"188"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6","spread":"14"},{"groupId":"OG001","value":"-2","spread":"15"}]}]}]},{"type":"SECONDARY","title":"Change in Short Form-36 (SF-36) - Physical Functioning Score","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"407"},{"groupId":"OG001","value":"204"}]}],"classes":[{"title":"Change in physical functioning score (SF-36)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"5.7"},{"groupId":"OG001","value":"1.7","spread":"5.7"}]}]},{"title":"Change in SF-36: Role-Physical score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"6.5"},{"groupId":"OG001","value":"1.5","spread":"6.7"}]}]},{"title":"Change in SF-36: Bodily Pain score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"7.1"},{"groupId":"OG001","value":"0.6","spread":"8.3"}]}]},{"title":"Change in SF-36: General Health score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.4","spread":"6.6"},{"groupId":"OG001","value":"1.9","spread":"6.4"}]}]},{"title":"Change in SF-36: Vitality score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"8.2"},{"groupId":"OG001","value":"0.9","spread":"7.8"}]}]},{"title":"Change in SF-36: Social Functioning score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"6.6"},{"groupId":"OG001","value":"-1.2","spread":"8.0"}]}]},{"title":"Change in SF-36: Mental Health score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"6.0"},{"groupId":"OG001","value":"-1.5","spread":"7.1"}]}]},{"title":"Change in SF-36: Physical component summary","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.2","spread":"6.0"},{"groupId":"OG001","value":"2.6","spread":"6.5"}]}]},{"title":"Change in SF-36: Mental component summary","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"6.0"},{"groupId":"OG001","value":"-2.2","spread":"8.0"}]}]},{"title":"Change in SF-36: Role-Emotional score","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"5.6"},{"groupId":"OG001","value":"-1.5","spread":"7.7"}]}]}]},{"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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-17.5","spread":"11.4"},{"groupId":"OG001","value":"-6.2","spread":"8.6"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index","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 randomisation (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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"373"},{"groupId":"OG001","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"4.0"},{"groupId":"OG001","value":"-2.2","spread":"3.1"}]}]}]},{"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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"184"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.3"},{"groupId":"OG001","value":"-0.3","spread":"0.2"}]}]}]},{"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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"369"},{"groupId":"OG001","value":"184"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.8","spread":"3.1"},{"groupId":"OG001","value":"-3.1","spread":"2.5"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose from 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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"355"},{"groupId":"OG001","value":"176"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.3","spread":"10.9"},{"groupId":"OG001","value":"-1.1","spread":"10.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Serum Insulin","description":"Change in fasting serum insulin from week 0 to week 68 \\[measured as milli-international units per milliliter (mIU/mL)\\] 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 randomisation (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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"346"},{"groupId":"OG001","value":"170"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.68","spread":"67.4"},{"groupId":"OG001","value":"0.84","spread":"50.6"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure","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 randomisation (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":"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"372"},{"groupId":"OG001","value":"188"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3","spread":"10"},{"groupId":"OG001","value":"-1","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in fasting total cholesterol from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"15.0"},{"groupId":"OG001","value":"1.01","spread":"12.3"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoproteins (HDL)","description":"Change in fasting HDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"14.6"},{"groupId":"OG001","value":"1.05","spread":"15.0"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoproteins (LDL)","description":"Change in fasting LDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"23.2"},{"groupId":"OG001","value":"1.01","spread":"18.6"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low Density Lipoprotein (VLDL)","description":"Change in fasting VLDL from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"40.9"},{"groupId":"OG001","value":"0.91","spread":"38.6"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids","description":"Change in fasting free fatty acids from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"346"},{"groupId":"OG001","value":"171"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.86","spread":"69.9"},{"groupId":"OG001","value":"1.08","spread":"71.8"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides","description":"Change in fasting triglycerides from baseline (week 0) to week 68 (measured as mg/dL) 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 randomisation (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 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"181"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.77","spread":"41.3"},{"groupId":"OG001","value":"0.91","spread":"39.1"}]}]}]},{"type":"SECONDARY","title":"Change in High Sensitivity C-reactive Protein","description":"Change in high sensitivity C-reactive protein 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 randomisation (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":"milligrams per litre (mg/L)","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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"363"},{"groupId":"OG001","value":"182"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.40","spread":"108.7"},{"groupId":"OG001","value":"0.76","spread":"75.5"}]}]}]},{"type":"SECONDARY","title":"Change in Plasminogen Activator Inhibitor-1 Activity","description":"Change in plasminogen activator inhibitor-1 activity 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 randomisation (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":"Arbritary units per milliliter (AU/ml)","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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"343"},{"groupId":"OG001","value":"162"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"80.6"},{"groupId":"OG001","value":"1.26","spread":"74.2"}]}]}]},{"type":"SECONDARY","title":"Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score","description":"The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, \"Yes\" infers 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 uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).","populationDescription":"FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"After 68 weeks","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"364"},{"groupId":"OG001","value":"181"}]}],"classes":[{"title":"Yes (with threshold 4.3)","categories":[{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"36"}]}]},{"title":"No (with threshold 4.3)","categories":[{"measurements":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"145"}]}]},{"title":"Yes (with threshold 3.7)","categories":[{"measurements":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"51"}]}]},{"title":"No (with threshold 3.7)","categories":[{"measurements":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"130"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"Change in body weight from baseline (week 0) to week 8 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 randomisation (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":"Percentage","timeFrame":"Baseline (week 0) to week 8","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"197"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.8","spread":"3.1"},{"groupId":"OG001","value":"-6.0","spread":"3.6"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (AEs)","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 that had onset date (or increase in severity) on or after the first day of exposure to treatment. 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"407"},{"groupId":"OG001","value":"204"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4035"},{"groupId":"OG001","value":"1325"}]}]}]},{"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"407"},{"groupId":"OG001","value":"204"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"7"}]}]}]},{"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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"334"},{"groupId":"OG001","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3","spread":"11"},{"groupId":"OG001","value":"2","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase","description":"Change in amylase (measured as 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.12","spread":"19"},{"groupId":"OG001","value":"1.07","spread":"18.1"}]}]}]},{"type":"SECONDARY","title":"Change in Lipase","description":"Change in lipase (measured as 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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"161"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.31","spread":"52"},{"groupId":"OG001","value":"0.94","spread":"39.4"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin","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 semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"162"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"40.6"},{"groupId":"OG001","value":"0.94","spread":"33.2"}]}]}]}]},"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 randomised treatment and no later than the date of last dose + 7 weeks.","eventGroups":[{"id":"EG000","title":"Semaglutide 2.4 mg","description":"Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. 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 Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.","deathsNumAffected":0,"deathsNumAtRisk":407,"seriousNumAffected":37,"seriousNumAtRisk":407,"otherNumAffected":379,"otherNumAtRisk":407},{"id":"EG001","title":"Placebo","description":"Participants were to receive once-weekly s.c injection of matching semaglutide placebo using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide placebo 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, and 1.7 mg) every fourth week until a maintenance dose of 2.4 mg of semaglutide placebo was reached. 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 IBT, which involves physical activity and dietary intervention with the first 8 weeks of LCD followed by a strict hypo-caloric diet till the end of treatment.","deathsNumAffected":0,"deathsNumAtRisk":204,"seriousNumAffected":6,"seriousNumAtRisk":204,"otherNumAffected":177,"otherNumAtRisk":204}],"seriousEvents":[{"term":"Abdominal abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Biliary dyskinesia","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Castleman's disease","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":407},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":204}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Cerebral infarction","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Cervical spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Deep vein thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Gastroenteritis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Haemorrhoids thrombosed","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Hip fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Hydronephrosis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Hypokalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Incarcerated inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":407},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":204}]},{"term":"Inguinal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":407},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":204}]},{"term":"Intervertebral disc protrusion","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Invasive lobular breast carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":407},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":204}]},{"term":"Iron deficiency anaemia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Joint dislocation","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Large intestine infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Neck dissection","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Obesity","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":407},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":204}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Papillary thyroid cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Pelvic inflammatory disease","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Small intestinal obstruction","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":407},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":204}]},{"term":"Spinal compression fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":407},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":204}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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