{"protocolSection":{"identificationModule":{"nctId":"NCT03693430","orgStudyIdInfo":{"id":"NN9536-4378"},"secondaryIdInfos":[{"id":"2017-003726-32","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"U1111-1202-1740","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity","officialTitle":"Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity","acronym":"STEP 5"},"statusModule":{"statusVerifiedDate":"2023-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-10-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-29","type":"ACTUAL"},"completionDateStruct":{"date":"2021-03-23","type":"ACTUAL"},"studyFirstSubmitDate":"2018-10-01","studyFirstSubmitQcDate":"2018-10-01","studyFirstPostDateStruct":{"date":"2018-10-03","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-02-02","resultsFirstSubmitQcDate":"2022-03-21","resultsFirstPostDateStruct":{"date":"2022-03-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-07-05","lastUpdatePostDateStruct":{"date":"2023-07-06","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 body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking \"dummy\" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or \"dummy\" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor."},"conditionsModule":{"conditions":["Overweight","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":304,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.","interventionNames":["Drug: Placebo (Semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Placebo (Semaglutide)","description":"S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage Change From Baseline (Week 0) to Week 104 in Body Weight","description":"Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%","description":"Number of participants who achieved greater than or equal to (\\>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=5% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"At Week 104"}],"secondaryOutcomes":[{"measure":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%","description":"Number of participants who achieved \\>=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=10% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"At Week 104"},{"measure":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%","description":"Number of participants who achieved \\>=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=15% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"At Week 104"},{"measure":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%","description":"Number of participants who achieved \\>=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=20% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"At Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Body Weight (kg)","description":"Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)","description":"Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Total Cholesterol-ratio to Baseline","description":"Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline","description":"Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline","description":"Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline","description":"Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Free Fatty Acids-ratio to Baseline","description":"Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Triglycerides-ratio to Baseline","description":"Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline","description":"Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Glycated Haemoglobin (HbA1c) (Percent [%])","description":"Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)","description":"Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)","description":"Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)","description":"Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)","description":"Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)","description":"Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Percentage Change From Baseline (Week 0) to Week 52 in Body Weight","description":"Percentage change in body weight from baseline (week 0) to week 52 is presented.","timeFrame":"From Baseline (Week 0) to Week 52"},{"measure":"Change From Baseline (Week 0) to Week 52 in Body Weight (kg)","description":"Change in body weight from baseline (week 0) to week 52 in kg is presented.","timeFrame":"From Baseline (Week 0) to Week 52"},{"measure":"Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)","description":"Change in BMI from baseline (week 0) to week 52 is presented.","timeFrame":"From Baseline (Week 0) to Week 52"},{"measure":"Change From Baseline (Week 0) to Week 52 in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to week 52 is presented.","timeFrame":"From Baseline (Week 0) to Week 52"},{"measure":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%","description":"Number of participants who achieved \\>=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=5% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=5% weight loss.","timeFrame":"At Week 52"},{"measure":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%","description":"Number of participants who achieved \\>=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=10% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=10% weight loss.","timeFrame":"At Week 52"},{"measure":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%","description":"Number of participants who achieved \\>=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=15% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=15% weight loss.","timeFrame":"At Week 52"},{"measure":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%","description":"Number of participants who achieved \\>=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=20% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=20% weight loss.","timeFrame":"At Week 52"},{"measure":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any unfavourable 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. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 111"},{"measure":"Number of Serious Adverse Events (SAEs)","description":"A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 111"},{"measure":"Change From Baseline (Week 0) to Week 104 in Pulse","description":"Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Amylase","description":"Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Lipase","description":"Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 104"},{"measure":"Change From Baseline (Week 0) to Week 104 in Calcitonin","description":"Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","timeFrame":"From Baseline (Week 0) to Week 104"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age more than or equal to 18 years at the time of signing informed consent\n* Body mass index (BMI) more than or equal to 30 kg/m\\^2 or more than or equal to 27 kg/m\\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExclusion criteria:\n\n* HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening\n* A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records","healthyVolunteers":false,"sex":"ALL","stdAges":["CHILD","ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Birmingham","state":"Alabama","zip":"35222","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Novo Nordisk Investigational Site","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Novo Nordisk Investigational Site","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"Novo Nordisk Investigational Site","city":"Golden","state":"Colorado","zip":"80401","country":"United States","geoPoint":{"lat":39.75554,"lon":-105.2211}},{"facility":"Novo Nordisk Investigational Site","city":"Waterbury","state":"Connecticut","zip":"06708","country":"United States","geoPoint":{"lat":41.55815,"lon":-73.0515}},{"facility":"Novo Nordisk Investigational Site","city":"Jacksonville","state":"Florida","zip":"32205","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Novo Nordisk Investigational Site","city":"Ocala","state":"Florida","zip":"34471","country":"United States","geoPoint":{"lat":29.1872,"lon":-82.14009}},{"facility":"Novo Nordisk Investigational Site","city":"City of Saint Peters","state":"Missouri","zip":"63303","country":"United States","geoPoint":{"lat":38.80033,"lon":-90.62651}},{"facility":"Novo Nordisk Investigational Site","city":"Butte","state":"Montana","zip":"59701","country":"United 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Investigational Site","city":"Seville","zip":"41010","country":"Spain","geoPoint":{"lat":37.38283,"lon":-5.97317}}]},"referencesModule":{"references":[{"pmid":"32441473","type":"BACKGROUND","citation":"Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, 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":"36655300","type":"BACKGROUND","citation":"Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18."},{"pmid":"39226070","type":"DERIVED","citation":"Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A. Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials. JAMA Intern Med. 2024 Nov 1;184(11):1290-1300. doi: 10.1001/jamainternmed.2024.4346."},{"pmid":"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":"36216945","type":"DERIVED","citation":"Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized in a 1:1 manner to receive treatment with semaglutide 2.4 milligram (mg) or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 104 weeks treatment period (16 weeks of dose escalation period and 88 weeks of maintenance dose).","recruitmentDetails":"The trial was conducted at 41 sites in 5 countries as follows: Canada (9 sites), Hungary (6 sites), Italy (5 sites), Spain (6 sites), and United States (15 sites).","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"152"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"152"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"152"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"134"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"18"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set (FAS) included all randomised participants according to the intention-to-treat principle.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"BG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"152"},{"groupId":"BG001","value":"152"},{"groupId":"BG002","value":"304"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47","spread":"12"},{"groupId":"BG001","value":"47","spread":"10"},{"groupId":"BG002","value":"47","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"123"},{"groupId":"BG001","value":"113"},{"groupId":"BG002","value":"236"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"68"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"39"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"134"},{"groupId":"BG001","value":"131"},{"groupId":"BG002","value":"265"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"141"},{"groupId":"BG001","value":"142"},{"groupId":"BG002","value":"283"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"12"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"}]},{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage Change From Baseline (Week 0) to Week 104 in Body Weight","description":"Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage change","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-15.9","spread":"12.3"},{"groupId":"OG001","value":"-1.9","spread":"8.9"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"109"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-17.3","spread":"11.9"},{"groupId":"OG001","value":"-2.0","spread":"8.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.","pValue":"<.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-12.55","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.33","ciUpperLimit":"-9.77"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.","pValue":"<0.0001","statisticalMethod":"MMRM (Mixed model repeated measurement)","paramType":"Treatment difference","paramValue":"-16.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.64","ciUpperLimit":"-13.45"}]},{"type":"PRIMARY","title":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%","description":"Number of participants who achieved greater than or equal to (\\>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=5% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"title":"In-trial observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"44"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"84"}]}]},{"title":"On-treatment observation period","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"109"}]}],"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"38"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"71"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.95","ciUpperLimit":"8.42"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM","paramType":"Odds Ratio (OR)","paramValue":"18.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"10.04","ciUpperLimit":"32.49"}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%","description":"Number of participants who achieved \\>=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=10% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"89"},{"groupId":"OG001","value":"17"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"111"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%","description":"Number of participants who achieved \\>=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=15% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"9"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"119"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%","description":"Number of participants who achieved \\>=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=20% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"3"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"125"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimeter (cm)","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"126"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.2","spread":"12.4"},{"groupId":"OG001","value":"-4.3","spread":"9.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Body Weight (kg)","description":"Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.9","spread":"14.0"},{"groupId":"OG001","value":"-2.1","spread":"9.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)","description":"Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram per square meter (kg/m^2)","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"128"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"5.3"},{"groupId":"OG001","value":"-0.7","spread":"3.5"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeter of mercury (mmHg)","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6","spread":"13"},{"groupId":"OG001","value":"-1","spread":"15"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"10"},{"groupId":"OG001","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol-ratio to Baseline","description":"Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"15.3"},{"groupId":"OG001","value":"1.02","spread":"13.5"}]}]}]},{"type":"SECONDARY","title":"Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline","description":"Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.09","spread":"19.1"},{"groupId":"OG001","value":"1.08","spread":"15.4"}]}]}]},{"type":"SECONDARY","title":"Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline","description":"Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"23.8"},{"groupId":"OG001","value":"0.99","spread":"19.1"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline","description":"Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.79","spread":"42.3"},{"groupId":"OG001","value":"1.03","spread":"35.1"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids-ratio to Baseline","description":"Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"111"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"71.2"},{"groupId":"OG001","value":"1.07","spread":"69.1"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides-ratio to Baseline","description":"Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.79","spread":"42.4"},{"groupId":"OG001","value":"1.03","spread":"36.0"}]}]}]},{"type":"SECONDARY","title":"Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline","description":"Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of hsCRP","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"121"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.41","spread":"149.1"},{"groupId":"OG001","value":"0.99","spread":"105.5"}]}]}]},{"type":"SECONDARY","title":"Change in Glycated Haemoglobin (HbA1c) (Percent [%])","description":"Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percent of glycated haemoglobin","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.3"},{"groupId":"OG001","value":"-0.1","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)","description":"Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/mol","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.1","spread":"3.2"},{"groupId":"OG001","value":"-1.0","spread":"3.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)","description":"Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"117"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.5"},{"groupId":"OG001","value":"0.1","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)","description":"Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"117"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.3","spread":"9.6"},{"groupId":"OG001","value":"1.8","spread":"10.8"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)","description":"Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting serum insulin","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"110"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.68","spread":"54.1"},{"groupId":"OG001","value":"0.96","spread":"62.9"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)","description":"Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting serum insulin","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"110"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.68","spread":"54.1"},{"groupId":"OG001","value":"0.96","spread":"62.9"}]}]}]},{"type":"SECONDARY","title":"Percentage Change From Baseline (Week 0) to Week 52 in Body Weight","description":"Percentage change in body weight from baseline (week 0) to week 52 is presented.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage change","timeFrame":"From Baseline (Week 0) to Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.8","spread":"9.3"},{"groupId":"OG001","value":"-3.3","spread":"6.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 52 in Body Weight (kg)","description":"Change in body weight from baseline (week 0) to week 52 in kg is presented.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram (kg)","timeFrame":"From Baseline (Week 0) to Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.7","spread":"10.3"},{"groupId":"OG001","value":"-3.5","spread":"7.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)","description":"Change in BMI from baseline (week 0) to week 52 is presented.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram per square meter (kg/m^2)","timeFrame":"From Baseline (Week 0) to Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.1","spread":"3.8"},{"groupId":"OG001","value":"-1.3","spread":"2.6"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 52 in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to week 52 is presented.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"centimeter (cm)","timeFrame":"From Baseline (Week 0) to Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.3","spread":"9.4"},{"groupId":"OG001","value":"-4.5","spread":"6.8"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%","description":"Number of participants who achieved \\>=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=5% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=5% weight loss.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"38"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"91"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%","description":"Number of participants who achieved \\>=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=10% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=10% weight loss.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"17"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"112"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%","description":"Number of participants who achieved \\>=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=15% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=15% weight loss.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"7"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"122"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%","description":"Number of participants who achieved \\>=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>=20% weight loss, whereas 'No' infers the number of participants who have not achieved \\>=20% weight loss.","populationDescription":"The FAS included all randomised participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"129"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"3"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"126"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment-emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any unfavourable 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. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","populationDescription":"The safety analysis set (SAS) included all randomised participants exposed to at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"From Baseline (Week 0) to Week 111","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1645"},{"groupId":"OG001","value":"1059"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (SAEs)","description":"A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>7 consecutive missed doses (corresponding to \\>7 weeks off-treatment).","populationDescription":"The SAS included all randomised participants exposed to at least one dose of randomised treatment.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"From Baseline (Week 0) to Week 111","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"152"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"20"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Pulse","description":"Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute (beats/min)","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3","spread":"10"},{"groupId":"OG001","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Amylase","description":"Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Units/liter (U/L)","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.13","spread":"20.7"},{"groupId":"OG001","value":"1.02","spread":"15.1"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Lipase","description":"Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"U/L","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.47","spread":"52.3"},{"groupId":"OG001","value":"1.00","spread":"34.4"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline (Week 0) to Week 104 in Calcitonin","description":"Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \\>2 consecutive missed doses (corresponding to \\>2 weeks off-treatment).","populationDescription":"The SAS included all randomised participants exposed to at least one dose of randomised treatment. Overall Number of Participants Analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per liter (ng/L)","timeFrame":"From Baseline (Week 0) to Week 104","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104."},{"id":"OG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"102"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.99","spread":"21.5"},{"groupId":"OG001","value":"0.97","spread":"41.0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From Baseline (Week 0) to Week 111","description":"All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomized treatment and no later than the date of last dose + 7 weeks. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment.","eventGroups":[{"id":"EG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 88 weeks until week 104.","deathsNumAffected":1,"deathsNumAtRisk":152,"seriousNumAffected":12,"seriousNumAtRisk":152,"otherNumAffected":141,"otherNumAtRisk":152},{"id":"EG001","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 104 weeks.","deathsNumAffected":0,"deathsNumAtRisk":152,"seriousNumAffected":18,"seriousNumAtRisk":152,"otherNumAffected":117,"otherNumAtRisk":152}],"seriousEvents":[{"term":"Abdominal adhesions","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":152},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":152}]},{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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