{"protocolSection":{"identificationModule":{"nctId":"NCT03548987","orgStudyIdInfo":{"id":"NN9536-4376"},"secondaryIdInfos":[{"id":"U1111-1201-0898","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2017-003473-34","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity","officialTitle":"Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period","acronym":"STEP 4"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-06-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-02-22","type":"ACTUAL"},"completionDateStruct":{"date":"2020-03-20","type":"ACTUAL"},"studyFirstSubmitDate":"2018-05-25","studyFirstSubmitQcDate":"2018-05-25","studyFirstPostDateStruct":{"date":"2018-06-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-02-19","resultsFirstSubmitQcDate":"2021-02-19","resultsFirstPostDateStruct":{"date":"2021-03-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-01-07","lastUpdatePostDateStruct":{"date":"2022-01-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking \"dummy\" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.\n\nThe participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or \"dummy\" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years."},"conditionsModule":{"conditions":["Metabolism and Nutrition Disorder","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":902,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.\n\nMaintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68).\n\nThe trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.\n\nMaintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68).\n\nThe trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.","interventionNames":["Drug: Semaglutide","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Subcutaneous (under the skin) injection of semaglutide once-weekly.","armGroupLabels":["Placebo","Semaglutide"]},{"type":"DRUG","name":"Placebo","description":"Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Randomisation to Week 68 in Body Weight (%)","description":"Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (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":"Randomisation (week 20) to week 68"}],"secondaryOutcomes":[{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 20) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Physical Functioning Score (Short Form 36 [SF-36])","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). 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 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Body Weight [Kilogram (Kg)]","description":"Change in body weight from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomisation (week 20) to week 68"},{"measure":"Change in Body Mass Index (BMI)","description":"Change in BMI from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Haemoglobin A1c (HbA1c) [%]","description":"Change in HbA1c from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in HbA1c [Millimoles Per Mole (mmol/Mol)]","description":"Change in HbA1c from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)]","description":"Change in fasting plasma glucose from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)]","description":"Change in fasting plasma glucose from week 20 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Fasting Serum Insulin","description":"Change in fasting serum insulin from baseline (week 20) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Total Cholesterol","description":"Change in fasting total cholesterol from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in High-density Lipoproteins (HDL)","description":"Change in fasting HDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Low-density Lipoproteins (LDL)","description":"Change in fasting LDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Very Low-density Lipoproteins (VLDL)","description":"Change in fasting VLDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Free Fatty Acids","description":"Change in fasting free fatty acids from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Change in Triglycerides","description":"Change in fasting triglycerides from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomization (week 20) to week 68"},{"measure":"Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score","description":"The number of participants achieving at least a 4.3-point increase in SF-36 physical functioning score from baseline (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved 4.3 points of increase of the score and 'No' infers number of participants who have not achieved 4.3 points of increase of the score. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomisation (week 20) to week 68"},{"measure":"Subjects Who Gain Weight (Yes/no)","description":"The number of participants with weight gain from the start of the randomised period (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have gained weight and 'No' infers number of participants who have not gained weight. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Randomisation (week 20) to week 68"},{"measure":"Change in Body Weight","description":"The body weight change (%) 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Run-in (week 0) to week 68"},{"measure":"Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%","description":"The number of participants who achieved less than (\\<) 0% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved \\<0% weight loss whereas 'No' infers number of participants who have not achieved \\<0% 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Run-in (week 0) to week 68"},{"measure":"Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%","description":"The number of participants who achieved greater than or equal to (≥) 5% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 5% weight loss whereas 'No' infers number of participants who have not achieved ≥ 5% 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Run-in (week 0) to week 68"},{"measure":"Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%","description":"The number of participants who achieved ≥ 10% weight loss from week 0 to week 68 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Run-in (week 0) to week 68"},{"measure":"Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%","description":"The number of participants who achieved ≥ 15% weight loss from week 0 to week 68 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 run-in (week 0) to last trial-related subject-site contact (week 75).","timeFrame":"Run-in (week 0) to week 68"},{"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 (week 0-20 run-in period). The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).","timeFrame":"Run-in (week 0) to randomisation (week 20)"},{"measure":"Number of Treatment-emergent AEs","description":"An 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 TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 20-75). 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":"Randomisation (week 20) 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 during run-in period from week 0 to week 20 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":"Run-in (week 0) to randomisation (week 20)"},{"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 during run-in period from week 0 to week 20 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":"Randomisation (week 20) to week 75"},{"measure":"Change in Pulse","description":"Change in pulse rate from week 0 week to week 20 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":"Run-in (week 0) to randomisation (week 20)"},{"measure":"Change in Pulse","description":"Change in pulse from week 20 and 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":"Randomisation (week 20) to week 68"},{"measure":"Change in Amylase","description":"Change in amylase (measured as units per liter \\[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":"Run-in (week) 0 to randomization (week 20)"},{"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":"Randomisation (week 20) 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":"Run-in (week 0) to randomization (week 20)"},{"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":"Randomisation (week 20) to week 68"},{"measure":"Change in Calcitonin","description":"Change in calcitonin (measured as nanogram per liter (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":"Run-in (week 0) to randomization (week 20)"},{"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":"Randomisation (week 20) to week 68"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm with the presence of at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by 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":"Anniston","state":"Alabama","zip":"36207","country":"United States","geoPoint":{"lat":33.65983,"lon":-85.83163}},{"facility":"Novo Nordisk Investigational Site","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Novo Nordisk Investigational Site","city":"San Diego","state":"California","zip":"92108","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Novo Nordisk Investigational Site","city":"Alpharetta","state":"Georgia","zip":"30022","country":"United States","geoPoint":{"lat":34.07538,"lon":-84.29409}},{"facility":"Novo Nordisk Investigational Site","city":"Roswell","state":"Georgia","zip":"30076","country":"United States","geoPoint":{"lat":34.02316,"lon":-84.36159}},{"facility":"Novo Nordisk Investigational Site","city":"Suwanee","state":"Georgia","zip":"30024","country":"United States","geoPoint":{"lat":34.05149,"lon":-84.0713}},{"facility":"Novo Nordisk Investigational Site","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Novo Nordisk Investigational Site","city":"Baton Rouge","state":"Louisiana","zip":"70808","country":"United States","geoPoint":{"lat":30.44332,"lon":-91.18747}},{"facility":"Novo Nordisk Investigational Site","city":"Elkridge","state":"Maryland","zip":"21075-6437","country":"United States","geoPoint":{"lat":39.21261,"lon":-76.71358}},{"facility":"Novo Nordisk Investigational Site","city":"Buckley","state":"Michigan","zip":"49620","country":"United 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Wadden TA, Wharton S, Wilding JPH, Rubino D. 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":"33755728","type":"RESULT","citation":"Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224."},{"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":"37605636","type":"DERIVED","citation":"Wilkinson L, Holst-Hansen T, Laursen PN, Rinnov AR, Batterham RL, Garvey WT. Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity. Obesity (Silver Spring). 2023 Sep;31(9):2249-2259. doi: 10.1002/oby.23842."},{"pmid":"36200477","type":"DERIVED","citation":"Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28."},{"pmid":"35724304","type":"DERIVED","citation":"Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785."},{"pmid":"30122305","type":"DERIVED","citation":"O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com/sharing-results"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial included 20-week run-in period and 48-week maintenance period. During the run-in period, participant started with a semaglutide dose of 0.25 mg and the dose was increased every fourth week until the target dose, 2.4 mg was reached. Out of 902 participants, 803 have completed the run-in period. Thus, these were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.","recruitmentDetails":"The trial was conducted in 73 sites in Denmark (2), Israel (6), Netherlands (3), Portugal (6), South Africa (6), Spain (7), Sweden (4), Switzerland (6), Ukraine (5) and United States (28).","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"FG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"periods":[{"title":"Run-in Period (Week 0 to Week 20)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"902"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"902"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"803"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Safety concern as judged by investigator","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Run-in failure","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Maintenance Period (Week 20 to Week 68)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"535"},{"groupId":"FG001","numSubjects":"268"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"535"},{"groupId":"FG001","numSubjects":"268"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"504"},{"groupId":"FG001","numSubjects":"237"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"31"}]}],"dropWithdraws":[{"type":"other","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"23"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"BG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"535"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"803"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47","spread":"12"},{"groupId":"BG001","value":"46","spread":"12"},{"groupId":"BG002","value":"46","spread":"12"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"429"},{"groupId":"BG001","value":"205"},{"groupId":"BG002","value":"634"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"169"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"63"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"493"},{"groupId":"BG001","value":"247"},{"groupId":"BG002","value":"740"}]},{"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":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"19"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"104"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"446"},{"groupId":"BG001","value":"226"},{"groupId":"BG002","value":"672"}]},{"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":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Randomisation to Week 68 in Body Weight (%)","description":"Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (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 = FAS which comprised all randomised participants. Number Analyzed = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage point","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"title":"In-trial","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.3","spread":"8.1"},{"groupId":"OG001","value":"6.5","spread":"7.7"}]}]},{"title":"On-treatment","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"234"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.8","spread":"7.8"},{"groupId":"OG001","value":"6.1","spread":"7.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-14.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.00","ciUpperLimit":"-13.50"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"MMRM (mixed model repeated measurement)","paramType":"Treatment difference","paramValue":"-15.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.52","ciUpperLimit":"-14.13"}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 20) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"518"},{"groupId":"OG001","value":"248"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.9","spread":"7.5"},{"groupId":"OG001","value":"3.2","spread":"7.0"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from week 20 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"518"},{"groupId":"OG001","value":"248"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"14"},{"groupId":"OG001","value":"5","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from week 20 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"518"},{"groupId":"OG001","value":"248"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"9"},{"groupId":"OG001","value":"1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Physical Functioning Score (Short Form 36 [SF-36])","description":"SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). 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 20 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 run-in (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":"Scores on a scale","timeFrame":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"245"}]}],"classes":[{"title":"Change in physical functioning score (SF-36)","categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"3.8"},{"groupId":"OG001","value":"-1.2","spread":"4.5"}]}]},{"title":"Change in SF-36 role-physical score","categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"5.0"},{"groupId":"OG001","value":"-0.9","spread":"5.3"}]}]},{"title":"Change in SF-36 bodily pain score","categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"7.0"},{"groupId":"OG001","value":"-1.5","spread":"7.7"}]}]},{"title":"Change in SF-36 general health score","categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"5.2"},{"groupId":"OG001","value":"-1.8","spread":"5.8"}]}]},{"title":"Change in SF-36 vitality score","categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"7.1"},{"groupId":"OG001","value":"-2.1","spread":"7.6"}]}]},{"title":"Change in SF-36 social functioning score","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"6.2"},{"groupId":"OG001","value":"-1.8","spread":"6.9"}]}]},{"title":"Change in SF-36 mental health score","categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"6.2"},{"groupId":"OG001","value":"-2.2","spread":"7.6"}]}]},{"title":"Change in SF-36 physical component summary","categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"4.9"},{"groupId":"OG001","value":"-0.9","spread":"5.6"}]}]},{"title":"Change in SF-36 mental component summary","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"6.2"},{"groupId":"OG001","value":"-2.4","spread":"8.5"}]}]},{"title":"Change in SF-36 role-emotional score","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"5.5"},{"groupId":"OG001","value":"-2.2","spread":"7.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight [Kilogram (Kg)]","description":"Change in body weight from week 20 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 run-in (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":"Kg","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.5","spread":"7.6"},{"groupId":"OG001","value":"5.7","spread":"6.7"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index (BMI)","description":"Change in BMI from week 20 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 run-in (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 per square meter (kg/sqm)","timeFrame":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.7","spread":"2.7"},{"groupId":"OG001","value":"2.0","spread":"2.4"}]}]}]},{"type":"SECONDARY","title":"Change in Haemoglobin A1c (HbA1c) [%]","description":"Change in HbA1c from week 20 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"246"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"0.3"},{"groupId":"OG001","value":"0.1","spread":"0.2"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c [Millimoles Per Mole (mmol/Mol)]","description":"Change in HbA1c from week 20 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"246"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.7","spread":"2.8"},{"groupId":"OG001","value":"1.2","spread":"2.7"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)]","description":"Change in fasting plasma glucose from week 20 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 run-in (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":"mg/dL","timeFrame":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"511"},{"groupId":"OG001","value":"242"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"8.6"},{"groupId":"OG001","value":"7.6","spread":"10.0"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)]","description":"Change in fasting plasma glucose from week 20 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 run-in (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/L","timeFrame":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"511"},{"groupId":"OG001","value":"242"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"0.5"},{"groupId":"OG001","value":"0.4","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Serum Insulin","description":"Change in fasting serum insulin from baseline (week 20) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"498"},{"groupId":"OG001","value":"240"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.81","spread":"60.9"},{"groupId":"OG001","value":"1.03","spread":"64.6"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol","description":"Change in fasting total cholesterol from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"517"},{"groupId":"OG001","value":"245"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"13.5"},{"groupId":"OG001","value":"1.11","spread":"14.4"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoproteins (HDL)","description":"Change in fasting HDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"245"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.18","spread":"13.2"},{"groupId":"OG001","value":"1.18","spread":"16.3"}]}]}]},{"type":"SECONDARY","title":"Change in Low-density Lipoproteins (LDL)","description":"Change in fasting LDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"517"},{"groupId":"OG001","value":"245"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.01","spread":"19.8"},{"groupId":"OG001","value":"1.07","spread":"21.3"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low-density Lipoproteins (VLDL)","description":"Change in fasting VLDL from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (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","timeFrame":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"517"},{"groupId":"OG001","value":"245"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"33.6"},{"groupId":"OG001","value":"1.12","spread":"39.0"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids","description":"Change in fasting free fatty acids from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"498"},{"groupId":"OG001","value":"240"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.78","spread":"79.4"},{"groupId":"OG001","value":"0.89","spread":"73.1"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides","description":"Change in fasting triglycerides from baseline (week 20) to week 68 (measured as mmol/L) 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 run-in (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":"Randomization (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"517"},{"groupId":"OG001","value":"245"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"33.9"},{"groupId":"OG001","value":"1.12","spread":"39.4"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score","description":"The number of participants achieving at least a 4.3-point increase in SF-36 physical functioning score from baseline (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved 4.3 points of increase of the score and 'No' infers number of participants who have not achieved 4.3 points of increase of the score. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (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":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"515"},{"groupId":"OG001","value":"245"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"11"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"457"},{"groupId":"OG001","value":"234"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Gain Weight (Yes/no)","description":"The number of participants with weight gain from the start of the randomised period (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have gained weight and 'No' infers number of participants who have not gained weight. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (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":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"206"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"441"},{"groupId":"OG001","value":"44"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight","description":"The body weight change (%) 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 run-in (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","timeFrame":"Run-in (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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-17.7","spread":"9.8"},{"groupId":"OG001","value":"-5.4","spread":"7.3"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%","description":"The number of participants who achieved less than (\\<) 0% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved \\<0% weight loss whereas 'No' infers number of participants who have not achieved \\<0% 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 run-in (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":"Run-in (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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"51"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"498"},{"groupId":"OG001","value":"199"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%","description":"The number of participants who achieved greater than or equal to (≥) 5% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 5% weight loss whereas 'No' infers number of participants who have not achieved ≥ 5% 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 run-in (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":"Run-in (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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"119"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"131"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%","description":"The number of participants who achieved ≥ 10% weight loss from week 0 to week 68 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 run-in (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":"Run-in (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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"411"},{"groupId":"OG001","value":"51"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"199"}]}]}]},{"type":"SECONDARY","title":"Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%","description":"The number of participants who achieved ≥ 15% weight loss from week 0 to week 68 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 run-in (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":"Run-in (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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"520"},{"groupId":"OG001","value":"250"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"23"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"227"}]}]}]},{"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 (week 0-20 run-in period). The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).","populationDescription":"SAS included all participants who received at least one dose of trial product.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Run-in (week 0) to randomisation (week 20)","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"902"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3775"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent AEs","description":"An 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 TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 20-75). 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. Only randomised subjects in the safety analysis set contribute.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1885"},{"groupId":"OG001","value":"779"}]}]}]},{"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 during run-in period from week 0 to week 20 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":"Run-in (week 0) to randomisation (week 20)","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"902"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}]}]},{"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 during run-in period from week 0 to week 20 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. Only randomised subjects in the safety analysis set contribute.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"19"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse rate from week 0 week to week 20 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. Only randomised subjects in the safety analysis set contribute.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Run-in (week 0) to randomisation (week 20)","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5","spread":"9"},{"groupId":"OG001","value":"5","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from week 20 and 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. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"bpm","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"495"},{"groupId":"OG001","value":"234"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"9"},{"groupId":"OG001","value":"-5","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Amylase","description":"Change in amylase (measured as units per liter \\[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. Only randomised subjects in the safety analysis set contribute.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Run-in (week) 0 to randomization (week 20)","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"18.7"},{"groupId":"OG001","value":"1.02","spread":"26.2"}]}]}]},{"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. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of amylase","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"494"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.06","spread":"19.9"},{"groupId":"OG001","value":"1.00","spread":"24.9"}]}]}]},{"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. Only randomised subjects in the safety analysis set contribute.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of lipase","timeFrame":"Run-in (week 0) to randomization (week 20)","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.44","spread":"40.2"},{"groupId":"OG001","value":"1.39","spread":"53.5"}]}]}]},{"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. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ratio of lipase","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"494"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"37.8"},{"groupId":"OG001","value":"0.68","spread":"51.7"}]}]}]},{"type":"SECONDARY","title":"Change in Calcitonin","description":"Change in calcitonin (measured as nanogram per liter (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. Only randomised subjects in the safety analysis set contribute.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Calcitonin","timeFrame":"Run-in (week 0) to randomization (week 20)","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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"535"},{"groupId":"OG001","value":"268"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.98","spread":"28.4"},{"groupId":"OG001","value":"0.96","spread":"28.1"}]}]}]},{"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. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of Calcitonin","timeFrame":"Randomisation (week 20) 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68."},{"id":"OG001","title":"Placebo","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"491"},{"groupId":"OG001","value":"233"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"24.8"},{"groupId":"OG001","value":"0.95","spread":"25.5"}]}]}]}]},"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: Run-in Period","description":"Participants were to receive once-weekly 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 in run-in period (week 0 to week 20) with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached.","deathsNumAffected":0,"deathsNumAtRisk":902,"seriousNumAffected":21,"seriousNumAtRisk":902,"otherNumAffected":670,"otherNumAtRisk":902},{"id":"EG001","title":"Semaglutide 2.4: Treatment Period","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 535 participants were continued to receive once weekly semaglutide s.c 2.4 mg until week 68.","deathsNumAffected":1,"deathsNumAtRisk":535,"seriousNumAffected":41,"seriousNumAtRisk":535,"otherNumAffected":295,"otherNumAtRisk":535},{"id":"EG002","title":"Placebo: Treatment Period","description":"Participants were to receive once-weekly 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 in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 268 participants were switched to receive once weekly placebo until week 68.","deathsNumAffected":1,"deathsNumAtRisk":268,"seriousNumAffected":15,"seriousNumAtRisk":268,"otherNumAffected":114,"otherNumAtRisk":268}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":902},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":535},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":268}]},{"term":"Abscess neck","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":902},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":535},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":268}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":902},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":535},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":268}]},{"term":"Ankle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":902},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":535},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":268}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":902},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":535},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":268}]},{"term":"Arthropod bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":902},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":535},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":268}]},{"term":"Arthroscopic surgery","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 22","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":902},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":535},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":268}]},{"term":"Atrial 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