{"protocolSection":{"identificationModule":{"nctId":"NCT04998136","orgStudyIdInfo":{"id":"NN9536-4707"},"secondaryIdInfos":[{"id":"U1111-1265-5285","type":"OTHER","domain":"World Health Organization (WHO)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity","officialTitle":"Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines"},"statusModule":{"statusVerifiedDate":"2025-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-08-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-10-16","type":"ACTUAL"},"completionDateStruct":{"date":"2023-11-20","type":"ACTUAL"},"studyFirstSubmitDate":"2021-08-04","studyFirstSubmitQcDate":"2021-08-04","studyFirstPostDateStruct":{"date":"2021-08-10","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-10-10","resultsFirstSubmitQcDate":"2025-03-14","resultsFirstPostDateStruct":{"date":"2025-04-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-09","lastUpdatePostDateStruct":{"date":"2025-12-30","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 looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a \"dummy\" medicine that looks like the study medicine, but has no effect on the body.\n\nParticipants will either get semaglutide or \"dummy\" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.\n\nParticipants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.\n\nThe study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken.\n\nParticipants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period."},"conditionsModule":{"conditions":["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":150,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide 2.4 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Semaglutide 2.4 mg"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo (semaglutide 2.4 mg)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide 2.4 mg","description":"Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg","armGroupLabels":["Semaglutide 2.4 mg"]},{"type":"DRUG","name":"Placebo (semaglutide 2.4 mg)","description":"Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Body Weight (%) : In-trial Observation Period","description":"Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Body Weight (%) : On-treatment Observation Period","description":"Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period","description":"Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"At week 44"},{"measure":"Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period","description":"Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.","timeFrame":"At week 44"}],"secondaryOutcomes":[{"measure":"Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"At week 44"},{"measure":"Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"At week 44"},{"measure":"Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"At week 44"},{"measure":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Body Weight (kg)","description":"Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","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 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Systolic Blood Pressure (mmHg)","description":"Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","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 the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Total Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Total Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","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 HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"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 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","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 LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Triglycerides (mg/dL) - Ratio to Baseline","description":"Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in Triglycerides (mmol/L) - Ratio to Baseline","description":"Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline","description":"Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","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 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"},{"measure":"Change in HbA1c (mmol/Mol)","description":"Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","timeFrame":"Baseline (week 0), end of treatment (week 44)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age above or equal to 18 years at the time of signing informed consent.\n* BMI at least 25.0 kg/m\\^2 at screening.\n* Both parents of Asian descent.\n* History of at least one self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n* HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus.\n* A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.\n* Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.\n* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m\\^2 at screening.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Transparency (dept. 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Konyang University Hospital","city":"Daejeon","zip":"35365","country":"South Korea","geoPoint":{"lat":36.34913,"lon":127.38493}},{"facility":"Dongguk University Ilsan Hospital_Gyeonggi-do","city":"Gyeonggi-do","zip":"10326","country":"South Korea","geoPoint":{"lat":37.58944,"lon":126.76917}},{"facility":"Hallym University Sacred Heart Hospital","city":"Gyeonggi-do","zip":"14068","country":"South Korea","geoPoint":{"lat":37.58944,"lon":126.76917}},{"facility":"Gachon University Gil Hospital","city":"Incheon","zip":"405-760","country":"South Korea","geoPoint":{"lat":37.45646,"lon":126.70515}},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si, Gyeonggi-do","zip":"13620","country":"South Korea"},{"facility":"SMG-SNU Boramae Medical Center","city":"Seoul","zip":"07061","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Ajou University Hospital","city":"Suwon","zip":"16499","country":"South Korea","geoPoint":{"lat":37.29111,"lon":127.00889}},{"facility":"King Chulalongkorn Memorial Hospital_Bangkok","city":"Bangkok","zip":"10330","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"King Chulalongkorn Memorial Hospital_Endocrinology","city":"Bangkok","zip":"10330","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"King Chulalongkorn Memorial Hospital_Obstetrics&Gynecology","city":"Bangkok","zip":"10330","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"Obstetrics&Gynecology King Chulalongkorn Memorial Hospital","city":"Bangkok","zip":"10330","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"Ramathibodi Hospital_Nutrition and Biochemical","city":"Bangkok","zip":"10400","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"Siriraj Hospital_Bangkok_1","city":"Bangkok","zip":"10700","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"Siriraj Hospital_Dept Cardio","city":"Bangkok","zip":"10700","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"Siriraj Institute of Clinical Research","city":"Bangkok","zip":"10700","country":"Thailand","geoPoint":{"lat":13.75398,"lon":100.50144}},{"facility":"Maharaj Nakorn Chiang Mai_Hematology and Oncology","city":"Chiang Mai","zip":"50200","country":"Thailand","geoPoint":{"lat":18.79038,"lon":98.98468}}]},"referencesModule":{"references":[{"pmid":"40825340","type":"DERIVED","citation":"Lim S, Buranapin S, Bao X, Quiroga M, Park KH, Kang JH, Rinnov AR, Suwanagool A. Once-weekly semaglutide 2.4 mg in an Asian population with obesity, defined as BMI >/=25 kg/m2, in South Korea and Thailand (STEP 11): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Oct;13(10):838-847. doi: 10.1016/S2213-8587(25)00164-0. Epub 2025 Aug 15."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The trial included an initial 16 weeks of dose escalation period and a 28 weeks of maintenance period. 150 eligible participants were randomized in a 2:1 manner to receive either Semaglutide or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity.","recruitmentDetails":"The trial was conducted at 13 sites in Republic of Korea and Thailand.","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received 2.4 milligram (mg) semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"FG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomized participants.","groups":[{"id":"BG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"BG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an 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":"101"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"150"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41","spread":"10"},{"groupId":"BG001","value":"37","spread":"11"},{"groupId":"BG002","value":"39","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"111"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"39"}]}]}]},{"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":"101"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"150"}]},{"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":"101"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"150"}]},{"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 (%) : In-trial Observation Period","description":"Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of body weight","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.4","spread":"7.3"},{"groupId":"OG001","value":"-2.6","spread":"5.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Treatment difference","paramValue":"-12.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.28","ciUpperLimit":"-10.70"}]},{"type":"PRIMARY","title":"Change in Body Weight (%) : On-treatment Observation Period","description":"Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of body weight","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.4","spread":"7.4"},{"groupId":"OG001","value":"-2.7","spread":"5.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM","paramType":"Treatment Difference","paramValue":"-13.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.70","ciUpperLimit":"-11.11"}]},{"type":"PRIMARY","title":"Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period","description":"Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 44","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"12"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"36"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"88.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"21.96","ciUpperLimit":"359.61"}]},{"type":"PRIMARY","title":"Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period","description":"Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 44","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"47"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"12"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"35"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \\>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"253.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"38.41","ciUpperLimit":"1672.57"}]},{"type":"SECONDARY","title":"Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 44","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"5"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"43"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 44","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"2"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"46"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At week 44","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"0"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"48"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.0","spread":"7.5"},{"groupId":"OG001","value":"-3.0","spread":"5.4"}]}]}]},{"type":"SECONDARY","title":"Change in Body Weight (kg)","description":"Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.0","spread":"5.5"},{"groupId":"OG001","value":"-2.0","spread":"5.1"}]}]}]},{"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 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.9","spread":"2.1"},{"groupId":"OG001","value":"-0.8","spread":"1.9"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure (mmHg)","description":"Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11","spread":"14"},{"groupId":"OG001","value":"-1","spread":"13"}]}]}]},{"type":"SECONDARY","title":"Change in Diastolic Blood Pressure","description":"Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4","spread":"11"},{"groupId":"OG001","value":"0","spread":"12"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"15.7"},{"groupId":"OG001","value":"1.03","spread":"12.3"}]}]}]},{"type":"SECONDARY","title":"Change in Total Cholesterol (mmol/L) - Ratio to Baseline","description":"Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.91","spread":"15.7"},{"groupId":"OG001","value":"1.03","spread":"12.3"}]}]}]},{"type":"SECONDARY","title":"Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline","description":"Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"15.3"},{"groupId":"OG001","value":"1.04","spread":"13.7"}]}]}]},{"type":"SECONDARY","title":"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 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of HDL cholesterol","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"15.3"},{"groupId":"OG001","value":"1.04","spread":"13.7"}]}]}]},{"type":"SECONDARY","title":"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 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"25.6"},{"groupId":"OG001","value":"1.04","spread":"21.6"}]}]}]},{"type":"SECONDARY","title":"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 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of LDL cholesterol","timeFrame":"Baseline (week 0), end of treatment (week 44)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.93","spread":"25.6"},{"groupId":"OG001","value":"1.04","spread":"21.6"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (mg/dL) - Ratio to Baseline","description":"Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"40.9"},{"groupId":"OG001","value":"0.96","spread":"42.1"}]}]}]},{"type":"SECONDARY","title":"Change in Triglycerides (mmol/L) - Ratio to Baseline","description":"Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"40.9"},{"groupId":"OG001","value":"0.96","spread":"42.1"}]}]}]},{"type":"SECONDARY","title":"Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline","description":"Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.54","spread":"170.0"},{"groupId":"OG001","value":"0.89","spread":"73.7"}]}]}]},{"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 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.3"},{"groupId":"OG001","value":"0.0","spread":"0.2"}]}]}]},{"type":"SECONDARY","title":"Change in HbA1c (mmol/Mol)","description":"Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).","populationDescription":"FAS included all randomized participants. Here, Overall number of participants analysed (N) = 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","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.5","spread":"3.2"},{"groupId":"OG001","value":"-0.1","spread":"2.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From (week 0) to (week 49).","description":"All presented AEs are TEAEs (treatment emergent adverse events).\n\nAdverse events will be defined as \"treatment-emergent\" (TEAE), if the onset of the event occurs in the on-treatment period.\n\nSafety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.","eventGroups":[{"id":"EG000","title":"Semaglutide","description":"Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.","deathsNumAffected":0,"deathsNumAtRisk":101,"seriousNumAffected":13,"seriousNumAtRisk":101,"otherNumAffected":80,"otherNumAtRisk":101},{"id":"EG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.","deathsNumAffected":0,"deathsNumAtRisk":49,"seriousNumAffected":4,"seriousNumAtRisk":49,"otherNumAffected":34,"otherNumAtRisk":49}],"seriousEvents":[{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":101},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":49}]},{"term":"Animal bite","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":101},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":49}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":101},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":49}]},{"term":"Chikungunya virus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":101},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":49}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":101},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":49}]},{"term":"Colitis ischaemic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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