{"protocolSection":{"identificationModule":{"nctId":"NCT05646706","orgStudyIdInfo":{"id":"NN9536-4999"},"secondaryIdInfos":[{"id":"U1111-1274-4259","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2022-000790-94","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)","officialTitle":"Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity","acronym":"STEP UP"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-01-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-10-30","type":"ACTUAL"},"completionDateStruct":{"date":"2024-11-26","type":"ACTUAL"},"studyFirstSubmitDate":"2022-12-02","studyFirstSubmitQcDate":"2022-12-02","studyFirstPostDateStruct":{"date":"2022-12-12","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-02","resultsFirstSubmitQcDate":"2026-04-02","resultsFirstPostDateStruct":{"date":"2026-04-23","type":"ACTUAL"},"dispFirstSubmitDate":"2025-10-20","dispFirstPostDateStruct":{"date":"2025-04-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-02","lastUpdatePostDateStruct":{"date":"2026-04-23","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 how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking \"dummy\" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or \"dummy\" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the \"dummy\" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions."},"conditionsModule":{"conditions":["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":1407,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 7.2 mg","type":"EXPERIMENTAL","description":"Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram \\[mg\\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.","interventionNames":["Drug: Semaglutide"]},{"label":"Semaglutide 2.4 mg","type":"EXPERIMENTAL","description":"Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.","armGroupLabels":["Semaglutide 7.2 mg"]},{"type":"DRUG","name":"Semaglutide","description":"Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.","armGroupLabels":["Semaglutide 2.4 mg"]},{"type":"DRUG","name":"Placebo","description":"Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight","description":"Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=5% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=5% and \"no\" defines participants who did not achieve body weight reduction \\>=5%.","timeFrame":"At week 72"}],"secondaryOutcomes":[{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=10% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=10% and \"no\" defines participants who did not achieve body weight reduction \\>=10%.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=15% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=15% and \"no\" defines participants who did not achieve body weight reduction \\>=15%.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=20% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=20% and \"no\" defines participants who did not achieve body weight reduction \\>=20%.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=25% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=25% and \"no\" defines participants who did not achieve body weight reduction \\>=25%.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight","description":"Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=20% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=20% and \"no\" defines participants who did not achieve body weight reduction \\>=20%.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=25% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=25% and \"no\" defines participants who did not achieve body weight reduction \\>=25%.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Body Weight","description":"Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)","description":"Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight","description":"Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)","description":"Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)","description":"Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)","description":"Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)","description":"Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)","description":"Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)","description":"Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Body Weight (%)","description":"Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)","description":"Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline","description":"Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline","description":"Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline","description":"Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline","description":"Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline","description":"Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline","description":"Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline","description":"Change in hsCRP (milligram per liter \\[mg/L\\]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)","description":"Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)","description":"Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase.","timeFrame":"At week 72"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline","description":"Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline","description":"Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)","description":"Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \\<5.7%; 2) Pre-diabetes: 5.7% \\<= HbA1c \\< 6.5%","timeFrame":"Baseline (week 0), end of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)","description":"Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.","timeFrame":"From baseline (week 0) to end of study (week 81)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)","description":"Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.","timeFrame":"From baseline (week 0) to end of study (week 81)"},{"measure":"Semaglutide 7.2 mg Versus Placebo: Change in Pulse","description":"Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.","timeFrame":"Baseline (week 0), End of treatment (week 72)"},{"measure":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs","description":"Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.","timeFrame":"From baseline (week 0) to end of study (week 81)"},{"measure":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs","description":"Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.","timeFrame":"From baseline (week 0) to end of study (week 81)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female.\n* Age above or equal to 18 years at the time of signing informed consent.\n* Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m\\^2).\n* History of at least one self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n* HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes.\n* Treatment with glucose-lowering agent(s) within 90 days before screening.\n* A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records.\n* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 2834)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Univ of Alabama Birmingham","city":"Birmingham","state":"Alabama","zip":"35294","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"Chambliss Clinical Trials, LLC","city":"Montgomery","state":"Alabama","zip":"36106","country":"United States","geoPoint":{"lat":32.36681,"lon":-86.29997}},{"facility":"Healthscan Clinical Trials,LLC.","city":"Montgomery","state":"Alabama","zip":"36106","country":"United States","geoPoint":{"lat":32.36681,"lon":-86.29997}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Jacksonville Ctr For Clin Res","city":"Jacksonville","state":"Florida","zip":"32216","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Florida Inst For Clin Res LLC","city":"Orlando","state":"Florida","zip":"32825","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Florida Institute For Clinical Research LLC","city":"Orlando","state":"Florida","zip":"32825","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"East West Med Res Inst","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Midwest 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Online ahead of print."},{"pmid":"40961952","type":"DERIVED","citation":"Wharton S, Freitas P, Hjelmesaeth J, Kabisch M, Kandler K, Lingvay I, Quiroga M, Rosenstock J, Garvey WT; STEP UP trial group. Once-weekly semaglutide 7.2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):949-963. doi: 10.1016/S2213-8587(25)00226-8. Epub 2025 Sep 14."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisktrials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial included a treatment period of 72 weeks (20 weeks of dose escalation and 52 weeks of maintenance period) followed by 9-week follow-up period. 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The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"171"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"632"},{"groupId":"OG001","value":"13"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"158"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=20% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=20% and \"no\" defines participants who did not achieve body weight reduction \\>=20%.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"171"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"453"},{"groupId":"OG001","value":"5"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"497"},{"groupId":"OG001","value":"166"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=25% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=25% and \"no\" defines participants who did not achieve body weight reduction \\>=25%.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"171"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"296"},{"groupId":"OG001","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"654"},{"groupId":"OG001","value":"171"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"171"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18.0","spread":"10.5"},{"groupId":"OG001","value":"-5.6","spread":"7.4"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight","description":"Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage (%) change in body weight","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-19.5","spread":"10.6"},{"groupId":"OG001","value":"-16.4","spread":"9.2"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=20% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=20% and \"no\" defines participants who did not achieve body weight reduction \\>=20%.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"189"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"453"},{"groupId":"OG001","value":"63"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"497"},{"groupId":"OG001","value":"126"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)","description":"Number of participants who achieve body weight reduction \\>=25% from baseline (week 0) is presented in categories as \"yes\" or \"no\" where \"yes\" defines participants who achieved body weight reduction \\>=25% and \"no\" defines participants who did not achieve body weight reduction \\>=25%.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"189"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"296"},{"groupId":"OG001","value":"29"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"654"},{"groupId":"OG001","value":"160"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Body Weight","description":"Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"171"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-21.7","spread":"12.3"},{"groupId":"OG001","value":"-4.3","spread":"8.0"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)","description":"Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram per square meter (kg/m^2)","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"171"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.7","spread":"4.4"},{"groupId":"OG001","value":"-1.5","spread":"2.9"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight","description":"Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"950"},{"groupId":"OG001","value":"189"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-21.7","spread":"12.3"},{"groupId":"OG001","value":"-18.7","spread":"10.4"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)","description":"Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in Statistical Analysis Plan(SAP) section 4.3.2, the reporting groups semaglutide 7.2 and semaglutide 2.4 mg were planned to be pooled for analysis of the outcome measure. Hence, data is represented in singled pooled semaglutide (7.2mg + 2.4mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of total fat volume","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-26.9","spread":"18.1"},{"groupId":"OG001","value":"-2.7","spread":"7.3"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)","description":"Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"liters","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.7","spread":"8.8"},{"groupId":"OG001","value":"-1.5","spread":"4.1"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)","description":"Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of lean body volume","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.5","spread":"7.4"},{"groupId":"OG001","value":"-0.4","spread":"4.2"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)","description":"Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"liters","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.9","spread":"2.0"},{"groupId":"OG001","value":"-0.2","spread":"0.9"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)","description":"Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of visceral fat volume","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-33.6","spread":"22.9"},{"groupId":"OG001","value":"-8.8","spread":"16.0"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)","description":"Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"liters","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"1.3"},{"groupId":"OG001","value":"-0.2","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Body Weight (%)","description":"Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of body weight","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18.4","spread":"11.9"},{"groupId":"OG001","value":"-2.1","spread":"4.9"}]}]}]},{"type":"SECONDARY","title":"Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)","description":"Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Pooled Semaglutide (7.2 mg + 2.4 mg)","description":"Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-20.6","spread":"14.7"},{"groupId":"OG001","value":"-2.7","spread":"6.5"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"949"},{"groupId":"OG001","value":"171"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10","spread":"14"},{"groupId":"OG001","value":"-4","spread":"12"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"949"},{"groupId":"OG001","value":"171"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5","spread":"9"},{"groupId":"OG001","value":"-1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline","description":"Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"935"},{"groupId":"OG001","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"16.7"},{"groupId":"OG001","value":"1.00","spread":"16.8"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline","description":"Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"935"},{"groupId":"OG001","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"16.7"},{"groupId":"OG001","value":"1.00","spread":"16.8"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"921"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"15.9"},{"groupId":"OG001","value":"1.02","spread":"15.2"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"921"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"15.9"},{"groupId":"OG001","value":"1.02","spread":"15.2"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline","description":"Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"921"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"25.5"},{"groupId":"OG001","value":"0.98","spread":"28.6"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline","description":"Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"921"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"25.5"},{"groupId":"OG001","value":"0.98","spread":"28.6"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"931"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"39.3"},{"groupId":"OG001","value":"1.00","spread":"36.8"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL cholesterol","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"931"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"39.3"},{"groupId":"OG001","value":"1.00","spread":"36.8"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline","description":"Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"933"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"40.9"},{"groupId":"OG001","value":"0.99","spread":"38.1"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline","description":"Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"933"},{"groupId":"OG001","value":"165"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.76","spread":"40.9"},{"groupId":"OG001","value":"0.99","spread":"38.1"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline","description":"Change in hsCRP (milligram per liter \\[mg/L\\]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of hsCRP","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"934"},{"groupId":"OG001","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.38","spread":"128.9"},{"groupId":"OG001","value":"0.89","spread":"89.9"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)","description":"Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"28"}]}],"classes":[{"title":"Decreased","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"22"}]}]},{"title":"Increased","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"6"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)","description":"Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 72","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"59"}]}],"classes":[{"title":"Decreased","categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"6"}]}]},{"title":"No change","categories":[{"measurements":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"47"}]}]},{"title":"Increased","categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"6"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)","description":"Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"% of HbA1c","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"938"},{"groupId":"OG001","value":"167"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.3"},{"groupId":"OG001","value":"0.0","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose","description":"Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"923"},{"groupId":"OG001","value":"160"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.7","spread":"11.9"},{"groupId":"OG001","value":"-1.7","spread":"11.7"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline","description":"Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting serum insulin","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"902"},{"groupId":"OG001","value":"158"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.61","spread":"66.6"},{"groupId":"OG001","value":"0.90","spread":"62.9"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline","description":"Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of fasting serum insulin","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"902"},{"groupId":"OG001","value":"158"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.61","spread":"66.6"},{"groupId":"OG001","value":"0.90","spread":"62.9"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)","description":"Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \\<5.7%; 2) Pre-diabetes: 5.7% \\<= HbA1c \\< 6.5%","populationDescription":"Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline (week 0), end of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"951"},{"groupId":"OG001","value":"168"}]}],"classes":[{"title":"Normo-glycaemia (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"595"},{"groupId":"OG001","value":"97"}]}],"categories":[{"title":"Normo-glycaemia (week 72)","measurements":[{"groupId":"OG000","value":"574"},{"groupId":"OG001","value":"75"}]},{"title":"Pre-diabetes (week 72)","measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"20"}]},{"title":"Diabetes (week 72)","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}]},{"title":"Pre-diabetes (week 0)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"356"},{"groupId":"OG001","value":"71"}]}],"categories":[{"title":"Normo-glycaemia (week 72)","measurements":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"26"}]},{"title":"Pre-diabetes (week 72)","measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"42"}]},{"title":"Diabetes (week 72)","measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)","description":"Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.","populationDescription":"Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to end of study (week 81)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1004"},{"groupId":"OG001","value":"201"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6430"},{"groupId":"OG001","value":"743"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)","description":"Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.","populationDescription":"Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to end of study (week 81)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1004"},{"groupId":"OG001","value":"201"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"16"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Placebo: Change in Pulse","description":"Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.","populationDescription":"Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute (bpm)","timeFrame":"Baseline (week 0), End of treatment (week 72)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"872"},{"groupId":"OG001","value":"140"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1","spread":"10"},{"groupId":"OG001","value":"-2","spread":"11"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs","description":"Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.","populationDescription":"Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to end of study (week 81)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1004"},{"groupId":"OG001","value":"201"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6430"},{"groupId":"OG001","value":"1133"}]}]}]},{"type":"SECONDARY","title":"Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs","description":"Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.","populationDescription":"Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to end of study (week 81)","groups":[{"id":"OG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72."},{"id":"OG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1004"},{"groupId":"OG001","value":"201"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"31"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline (week 0) to end of study (week 81)","description":"Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Adverse events were assessment based on safety analysis set and all cause mortality was assessed for all randomized participants in this study.","eventGroups":[{"id":"EG000","title":"Semaglutide 7.2 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72.","deathsNumAffected":0,"deathsNumAtRisk":1005,"seriousNumAffected":73,"seriousNumAtRisk":1004,"otherNumAffected":784,"otherNumAtRisk":1004},{"id":"EG001","title":"Semaglutide 2.4 mg","description":"Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 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