{"protocolSection":{"identificationModule":{"nctId":"NCT06041217","orgStudyIdInfo":{"id":"NN9536-4706"},"secondaryIdInfos":[{"id":"U1111-1273-4538","type":"OTHER","domain":"World Health Organization (WHO)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range","officialTitle":"Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity","acronym":"STEP12"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-09-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-04-02","type":"ACTUAL"},"completionDateStruct":{"date":"2025-05-07","type":"ACTUAL"},"studyFirstSubmitDate":"2023-09-11","studyFirstSubmitQcDate":"2023-09-11","studyFirstPostDateStruct":{"date":"2023-09-18","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-03-25","resultsFirstSubmitQcDate":"2026-04-24","resultsFirstPostDateStruct":{"date":"2026-05-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-24","lastUpdatePostDateStruct":{"date":"2026-05-18","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking \"dummy\" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff."},"conditionsModule":{"conditions":["Overweight","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":242,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 2.4 milligram (mg)","type":"EXPERIMENTAL","description":"Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.","armGroupLabels":["Semaglutide 2.4 milligram (mg)"]},{"type":"DRUG","name":"Placebo","description":"Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight (%)","description":"Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)","description":"Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.","timeFrame":"At end of treatment (week 44)"}],"secondaryOutcomes":[{"measure":"Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)","description":"Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.","timeFrame":"At end of treatment (week 44)"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Body Weight (kg)","description":"Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Body Mass Index","description":"Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Waist-height Ratio (WtHR)","description":"Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Total Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Triglycerides (mmol/L) - Ratio to Baseline","description":"Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Free Fatty Acids (mmol/L) - Ratio to Baseline","description":"Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline","description":"Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in HbA1c (%)","description":"Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in HbA1c (mmol/Mol)","description":"Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Fasting Plasma Glucose (mg/dL)","description":"Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Fasting Plasma Glucose (mmol/L)","description":"Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"Number of TEAEs from baseline (week 0) to end of study (week 49) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.","timeFrame":"From baseline (week 0) to end of study (week 49)"},{"measure":"Number of Serious Adverse Events (SAEs)","description":"Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.","timeFrame":"From baseline (week 0) to end of study (week 49)"},{"measure":"Change in Pulse","description":"Change in pulse from baseline (week 0) to end of treatment (week 44) is presented.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)","description":"Number of clinically significant hypoglycaemic episodes (level 2) (\\<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.","timeFrame":"From baseline (week 0) to end of study (week 49)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age greater than or equal to 18 years at the time of signing informed consent.\n* Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m\\^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m\\^2, with or without weight related complications at screening.\n* History of at least one self-reported unsuccessful dietary effort to lose body weight.\n\nFor participants with T2D at screening:\n\n\\- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening\n\nTreated with either:\n\n* Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.\n* Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening\n* Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol \\[mmol/mol\\]) as measured by the central laboratory at screening.\n\nExclusion Criteria:\n\n* A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records.\n* Treatment with any medication for the indication of obesity within the past 90 days before screening.\n* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.\n\nFor participants without T2D at screening:\n\n\\- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.\n\nFor participants with T2D at screening:\n\n* Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\\^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.","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":"Beijing Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100730","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Chongqing University Three Gorges Hospital","city":"Chongqing","state":"Chongqing Municipality","zip":"404000","country":"China","geoPoint":{"lat":29.56026,"lon":106.55771}},{"facility":"Fujian Medical University Union Hospital-Endocrinology","city":"Fuzhou","state":"Fujian","zip":"350001","country":"China","geoPoint":{"lat":26.06139,"lon":119.30611}},{"facility":"Huizhou Central People's Hospital-Endocrinology","city":"Huizhou","state":"Guangdong","zip":"516001","country":"China","geoPoint":{"lat":23.11147,"lon":114.41523}},{"facility":"Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology","city":"Hengshui","state":"Hebei","zip":"053000","country":"China","geoPoint":{"lat":37.73908,"lon":115.68348}},{"facility":"Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology","city":"Shiyan","state":"Hubei","zip":"442008","country":"China","geoPoint":{"lat":32.6475,"lon":110.77806}},{"facility":"Changzhou No.2 People's Hospital, Yanghu Branch","city":"Changzhou","state":"Jiangsu","zip":"213003","country":"China","geoPoint":{"lat":31.77359,"lon":119.95401}},{"facility":"The Second Affiliated Hospital of Nanjing Medical University-Endocrinology","city":"Nanjing","state":"Jiangsu","zip":"210011","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The Second Affiliated Hospital of Nanjing Medical University_Nanjing","city":"Nanjing","state":"Jiangsu","zip":"210011","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The Affiliated Hospital of Jiangsu University-Endocrinology","city":"Zhenjiang","state":"Jiangsu","zip":"212001","country":"China","geoPoint":{"lat":32.21086,"lon":119.45508}},{"facility":"The First Bethune hospital of Jilin University-Endocrinology","city":"Changchun","state":"Jilin","zip":"130061","country":"China","geoPoint":{"lat":43.88,"lon":125.32278}},{"facility":"Qinghai Provincial People's Hospital","city":"Xining","state":"Qinghai","zip":"810007","country":"China","geoPoint":{"lat":36.62554,"lon":101.75739}},{"facility":"Jinan Central Hospital","city":"Jinan","state":"Shandong","zip":"250013","country":"China","geoPoint":{"lat":36.66833,"lon":116.99722}},{"facility":"Shanghai Fifth People's Hospital-Endocrinology","city":"Shanghai","state":"Shanghai Municipality","zip":"200240","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Tongren Hospital Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"Shanghai Municipality","zip":"200336","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Shanghai Pudong New Area People's Hospital-Endocrinology","city":"Shanghai","state":"Shanghai Municipality","zip":"201200","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Ditmanson Medical Foundation Chia-Yi Christian Hospital","city":"Chiayi City","zip":"600","country":"Taiwan","geoPoint":{"lat":23.47917,"lon":120.44889}},{"facility":"China Medical University Hospital","city":"Taichung","zip":"404","country":"Taiwan","geoPoint":{"lat":24.1469,"lon":120.6839}},{"facility":"National Cheng Kung University Hospital","city":"Tainan","zip":"704","country":"Taiwan","geoPoint":{"lat":22.99083,"lon":120.21333}},{"facility":"National Taiwan University Hospital_main","city":"Taipei","zip":"100","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}},{"facility":"Taipei Medical University Hospital","city":"Taipei","zip":"110","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}}]},"referencesModule":{"references":[{"pmid":"42575111","type":"DERIVED","citation":"Guo L, Bao X, Huang KC, Kolnes KJ, Laugesen C, Lu Y, Luo B, Yuan G, Kushner RF. Efficacy and safety of once-weekly semaglutide 2.4 mg in Chinese adults with overweight or obesity (STEP 12): a randomised, double-blind, placebo-controlled, multicentre, phase 3b trial. Lancet Diabetes Endocrinol. 2026 Aug 10:S2213-8587(26)00133-6. doi: 10.1016/S2213-8587(26)00133-6. Online ahead of print."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisktrials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in 2:1 ratio to receive once weekly subcutaneous (s.c.) injection of either semaglutide 2.4 mg or semaglutide matching placebo as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 44-week treatment period (16 weeks of dose escalation period and 28 weeks of maintenance period), followed by a 5-week follow-up period.","recruitmentDetails":"The trial was conducted at 19 sites across mainland China and Taiwan.","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"FG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"81"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"81"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"81"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"79"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised participants.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"BG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"161"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"242"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42","spread":"10"},{"groupId":"BG001","value":"41","spread":"12"},{"groupId":"BG002","value":"41","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"121"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"121"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"161"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"242"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"161"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"242"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Body Weight (%)","description":"Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage change in body weight","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.2","spread":"8.2"},{"groupId":"OG001","value":"-2.2","spread":"5.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Week 44 responses were analysed using an analysis of covariance model with randomised treatment and type 2 diabetes status at screening as factors and baseline body weight as covariate.","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-9.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.78","ciUpperLimit":"-7.96"}]},{"type":"PRIMARY","title":"Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)","description":"Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"19"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"59"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy Estimand","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Week 44 responses were analysed using a binary logistic regression model with randomised treatment and type 2 diabetes status at screening as factors and baseline body weight as covariate.","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"14.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.42","ciUpperLimit":"29.63"}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)","description":"Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"title":"Yes","measurements":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"9"}]},{"title":"No","measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"69"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter (cm)","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.1","spread":"6.2"},{"groupId":"OG001","value":"-2.4","spread":"5.0"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)","description":"Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.3","spread":"6.1"},{"groupId":"OG001","value":"-1.7","spread":"4.3"}]}]}]},{"type":"SECONDARY","title":"Change in Body Mass Index","description":"Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kilogram per square meter (kg/m^2)","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.4","spread":"2.3"},{"groupId":"OG001","value":"-0.6","spread":"1.5"}]}]}]},{"type":"SECONDARY","title":"Change in Waist-height Ratio (WtHR)","description":"Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Ratio of waist-height","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.04"},{"groupId":"OG001","value":"-0.01","spread":"0.03"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure","description":"Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Millimeter of mercury (mmHg)","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7","spread":"13"},{"groupId":"OG001","value":"-4","spread":"10"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"9"},{"groupId":"OG001","value":"-2","spread":"8"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of total cholesterol","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.94","spread":"16.5"},{"groupId":"OG001","value":"1.01","spread":"13.1"}]}]}]},{"type":"SECONDARY","title":"Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.04","spread":"13.8"},{"groupId":"OG001","value":"1.06","spread":"13.7"}]}]}]},{"type":"SECONDARY","title":"Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"24.4"},{"groupId":"OG001","value":"1.02","spread":"24.1"}]}]}]},{"type":"SECONDARY","title":"Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of VLDL","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"44.2"},{"groupId":"OG001","value":"0.93","spread":"38.8"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (mmol/L) - Ratio to Baseline","description":"Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of triglycerides","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"156"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"46.5"},{"groupId":"OG001","value":"0.91","spread":"44.5"}]}]}]},{"type":"SECONDARY","title":"Change in Free Fatty Acids (mmol/L) - Ratio to Baseline","description":"Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of free fatty acids","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"77"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.88","spread":"60.2"},{"groupId":"OG001","value":"0.99","spread":"61.5"}]}]}]},{"type":"SECONDARY","title":"Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline","description":"Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of hsCRP","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.69","spread":"154.3"},{"groupId":"OG001","value":"0.68","spread":"118.2"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (%)","description":"Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.5"},{"groupId":"OG001","value":"0.0","spread":"0.3"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (mmol/Mol)","description":"Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/mol","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.2","spread":"5.9"},{"groupId":"OG001","value":"0.5","spread":"3.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (mg/dL)","description":"Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.3","spread":"18.4"},{"groupId":"OG001","value":"0.5","spread":"14.5"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Plasma Glucose (mmol/L)","description":"Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/L","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"78"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"1.0"},{"groupId":"OG001","value":"0.0","spread":"0.8"}]}]}]},{"type":"SECONDARY","title":"Number of Treatment Emergent Adverse Events (TEAEs)","description":"Number of TEAEs from baseline (week 0) to end of study (week 49) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.","populationDescription":"Safety analysis set (SAS) included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to end of study (week 49)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"161"},{"groupId":"OG001","value":"81"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"614"},{"groupId":"OG001","value":"183"}]}]}]},{"type":"SECONDARY","title":"Number of Serious Adverse Events (SAEs)","description":"Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.","populationDescription":"SAS included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Events","timeFrame":"From baseline (week 0) to end of study (week 49)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"161"},{"groupId":"OG001","value":"81"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Change in Pulse","description":"Change in pulse from baseline (week 0) to end of treatment (week 44) is presented.","populationDescription":"SAS included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beats per minute (Beats/min)","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3","spread":"11"},{"groupId":"OG001","value":"1","spread":"9"}]}]}]},{"type":"SECONDARY","title":"Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)","description":"Number of clinically significant hypoglycaemic episodes (level 2) (\\<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.","populationDescription":"SAS included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Episodes","timeFrame":"From baseline (week 0) to end of study (week 49)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From baseline (week 0) to end of study (week 49)","description":"An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. 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