{"protocolSection":{"identificationModule":{"nctId":"NCT05579249","orgStudyIdInfo":{"id":"NN9536-4741"},"secondaryIdInfos":[{"id":"U1111-1263-7301","type":"OTHER","domain":"World Health Organization (WHO)"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America","officialTitle":"Effectiveness of Semaglutide 2.4 mg vs. Commercially Available Medications for Chronic Weight Management in Participants With Obesity in a Multi-employer Setting in The US - a Pragmatic Clinical Study"},"statusModule":{"statusVerifiedDate":"2025-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-01-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-11-27","type":"ACTUAL"},"completionDateStruct":{"date":"2024-11-27","type":"ACTUAL"},"studyFirstSubmitDate":"2022-10-11","studyFirstSubmitQcDate":"2022-10-11","studyFirstPostDateStruct":{"date":"2022-10-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-11-27","resultsFirstSubmitQcDate":"2025-12-22","resultsFirstPostDateStruct":{"date":"2026-01-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-12-22","lastUpdatePostDateStruct":{"date":"2026-01-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The purpose of this post approval pragmatic clinical study is to see how well semaglutide lowers body weight compared to other medication on the market used to treat obesity, across three US-based employers. These employers represent employees of diverse demography and job functions including hospitality, clerical, administrative, housekeeping, maintenance, and specialised employees across a range of socioeconomic and educational backgrounds. The study will also look at how weight loss affects physical functioning, quality of life and ability to work. It will also gather information on how satisfied participants are with the medication they take. Participants will either receive semaglutide or one of 4 approved anti-obesity medication (Xenical/Qsymia/Contrave/Saxenda)."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":500,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.","interventionNames":["Drug: Semaglutide"]},{"label":"Other anti-obesity medication","type":"ACTIVE_COMPARATOR","description":"Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications are orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.","interventionNames":["Drug: Orlistat","Drug: Phentermine/Topiramate","Drug: Naltrexone/Bupropion","Drug: Liraglutide"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.","armGroupLabels":["Semaglutide"],"otherNames":["Wegovy"]},{"type":"DRUG","name":"Orlistat","description":"Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.","armGroupLabels":["Other anti-obesity medication"],"otherNames":["Xenical"]},{"type":"DRUG","name":"Phentermine/Topiramate","description":"Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.","armGroupLabels":["Other anti-obesity medication"],"otherNames":["Qsymia"]},{"type":"DRUG","name":"Naltrexone/Bupropion","description":"Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.","armGroupLabels":["Other anti-obesity medication"],"otherNames":["Contrave"]},{"type":"DRUG","name":"Liraglutide","description":"Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.","armGroupLabels":["Other anti-obesity medication"],"otherNames":["Saxenda"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)","description":"Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.","timeFrame":"At end of treatment (week 52)"}],"secondaryOutcomes":[{"measure":"Percentage Change in Body Weight","description":"Percentage change in body weight from week 0 to week 52 is presented.","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain","description":"The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency (\"never\" to \"always\") scale or a 5-point truth (\"not at all true\" to \"completely true\") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain.","timeFrame":"Baseline (week 0), end of treatment (week 52)"},{"measure":"Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to 15.0% body weight reduction (yes/no) at week 52 is presented.","timeFrame":"At end of treatment (week 52)"},{"measure":"Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to 20.0% body weight reduction (yes/no) at week 52 is presented.","timeFrame":"At end of treatment (week 52)"},{"measure":"Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)","description":"The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency (\"never\" to \"always\") scale or a 5-point truth (\"not at all true\" to \"completely true\") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain score ≥ 14.6.","timeFrame":"At end of treatment (week 52)"},{"measure":"Percentage of Days Covered (PDC) by Study Product","description":"Percentage of days covered by study product from week 0 to week 52 is presented. The percentage of days covered by the study product is determined by the duration on the study product divided by the planned study duration, multiplied by 100.","timeFrame":"From week 0 to week 52"},{"measure":"Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)","description":"Number of participants covered by study product ≥80% of days (yes/no) from week 0 to week 52 is presented.","timeFrame":"At end of treatment (week 52)"},{"measure":"Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS)","description":"Work Limitations Questionnaire (WLQ-25) is a 25-item questionnaire that measures how health problems affect job performance and productivity over the past two weeks, using a 5-point Likert scale. It covers four domains: Time Management (5 items), Physical Demands (6), Mental/Interpersonal (9), and Output Demands (5). Each item is scored from 1 to 5, with subscale scores calculated as the average item score, then converted to a 0-100 scale using the formula: WLQ Scale Score= 25 × (average item score - 1). Thus, each subscale ranges from 0 (no limitation) to 100 (maximum limitation). The WLQ total score is computed by applying specific weights to each subscale and summing them: 0.00048 × Time scale + 0.00036 × Physical scale + 0.00096 × Mental/Interpersonal scale + 0.00106 × Output scale. This total is then transformed into the proportion of productivity loss using the formula: (1 - exp(-total score)).","timeFrame":"Baseline (week 0), end of treatment (week 52)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Body mass index (BMI) greater than equal to 30.0 kilogram per meter square (kg/m\\^2).\n* Employed at randomisation by one of the selected employers and expecting to be so for the duration of the study.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity or contraindications to Wegovy or related products according to the label.\n* Known or suspected hypersensitivity or contraindications to all of the other Anti-Obesity Medications (AOMs) for chronic weight management (Xenical, Qsymia, Contrave, and Saxenda) or related products according to the labels.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.\n* History of type 1 or type 2 diabetes mellitus.\n* Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.","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":"Nutrition Research Centre","city":"Loma Linda","state":"California","zip":"92354","country":"United States","geoPoint":{"lat":34.04835,"lon":-117.26115}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The study was conducted at one site in United States.","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"FG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"250"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"250"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"242"},{"groupId":"FG001","numSubjects":"242"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"214"},{"groupId":"FG001","numSubjects":"191"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"59"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"52"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set included all randomized participants.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"BG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"250"},{"groupId":"BG001","value":"250"},{"groupId":"BG002","value":"500"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.6","spread":"9.3"},{"groupId":"BG001","value":"42.0","spread":"10.3"},{"groupId":"BG002","value":"41.3","spread":"9.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"225"},{"groupId":"BG001","value":"223"},{"groupId":"BG002","value":"448"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"52"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"159"},{"groupId":"BG001","value":"150"},{"groupId":"BG002","value":"309"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"100"},{"groupId":"BG002","value":"191"}]},{"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":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"24"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"50"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"193"},{"groupId":"BG001","value":"202"},{"groupId":"BG002","value":"395"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)","description":"Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.","populationDescription":"Full analysis set included all randomized 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 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"177"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"61"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"116"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Week 52 responses were analysed using a binary regression model with randomized treatment as factor and baseline body weight as covariate.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Regression, Linear","paramType":"Odds Ratio (OR)","paramValue":"3.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.12","ciUpperLimit":"4.78"}]},{"type":"SECONDARY","title":"Percentage Change in Body Weight","description":"Percentage change in body weight from week 0 to week 52 is presented.","populationDescription":"Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentange change in body weight","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"177"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.6","spread":"8.7"},{"groupId":"OG001","value":"-7.4","spread":"7.3"}]}]}]},{"type":"SECONDARY","title":"Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain","description":"The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency (\"never\" to \"always\") scale or a 5-point truth (\"not at all true\" to \"completely true\") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain.","populationDescription":"Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25.6","spread":"21.2"},{"groupId":"OG001","value":"22.6","spread":"24.4"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to 15.0% body weight reduction (yes/no) at week 52 is presented.","populationDescription":"Full analysis set included all randomized 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 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"177"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"25"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"152"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)","description":"Number of participants who achieved more than or equal to 20.0% body weight reduction (yes/no) at week 52 is presented.","populationDescription":"Full analysis set included all randomized 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 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"177"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"8"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"169"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)","description":"The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency (\"never\" to \"always\") scale or a 5-point truth (\"not at all true\" to \"completely true\") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain score ≥ 14.6.","populationDescription":"Full analysis set included all randomized 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 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"163"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"108"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"55"}]}]}]},{"type":"SECONDARY","title":"Percentage of Days Covered (PDC) by Study Product","description":"Percentage of days covered by study product from week 0 to week 52 is presented. The percentage of days covered by the study product is determined by the duration on the study product divided by the planned study duration, multiplied by 100.","populationDescription":"Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of days covered","timeFrame":"From week 0 to week 52","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"242"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"83.7","spread":"24.6"},{"groupId":"OG001","value":"70.8","spread":"28.6"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)","description":"Number of participants covered by study product ≥80% of days (yes/no) from week 0 to week 52 is presented.","populationDescription":"Full analysis set included all randomized participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"250"}]}],"classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"113"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"137"}]}]}]},{"type":"SECONDARY","title":"Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS)","description":"Work Limitations Questionnaire (WLQ-25) is a 25-item questionnaire that measures how health problems affect job performance and productivity over the past two weeks, using a 5-point Likert scale. It covers four domains: Time Management (5 items), Physical Demands (6), Mental/Interpersonal (9), and Output Demands (5). Each item is scored from 1 to 5, with subscale scores calculated as the average item score, then converted to a 0-100 scale using the formula: WLQ Scale Score= 25 × (average item score - 1). Thus, each subscale ranges from 0 (no limitation) to 100 (maximum limitation). The WLQ total score is computed by applying specific weights to each subscale and summing them: 0.00048 × Time scale + 0.00036 × Physical scale + 0.00096 × Mental/Interpersonal scale + 0.00106 × Output scale. This total is then transformed into the proportion of productivity loss using the formula: (1 - exp(-total score)).","populationDescription":"Full analysis set included all randomized participants Overall number of participants analyzed = participants with available data for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"Baseline (week 0), end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management."},{"id":"OG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"186"},{"groupId":"OG001","value":"159"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.034","spread":"0.070"},{"groupId":"OG001","value":"-0.016","spread":"0.048"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From week 0 to week 52","description":"All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.","eventGroups":[{"id":"EG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.","deathsNumAffected":0,"deathsNumAtRisk":250,"seriousNumAffected":3,"seriousNumAtRisk":242,"otherNumAffected":0,"otherNumAtRisk":242},{"id":"EG001","title":"Other Anti-obesity Medications (AOMs)","description":"Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \\[by mouth\\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.","deathsNumAffected":2,"deathsNumAtRisk":250,"seriousNumAffected":8,"seriousNumAtRisk":242,"otherNumAffected":0,"otherNumAtRisk":242}],"seriousEvents":[{"term":"Amyotrophic lateral sclerosis","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":242},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":242}]},{"term":"Atrioventricular block complete","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":242},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":242}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":242},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":242}]},{"term":"Drug hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":242},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":242}]},{"term":"Abortion spontaneous","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":242},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":242}]},{"term":"Cardiac arrest","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":242},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":242}]},{"term":"Diverticulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":242},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":242}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":242},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":242}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":242},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":242}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property."},"pointOfContact":{"title":"Clinical Reporting Office (2834)","organization":"Novo Nordisk A/S","email":"clinicaltrials@novonordisk.com","phone":"(+1) 866-867-7178"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2022-09-15","uploadDate":"2025-11-27T05:47","filename":"Prot_000.pdf","size":2645596},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2025-03-17","uploadDate":"2025-11-27T05:47","filename":"SAP_001.pdf","size":444395}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2025-12-12","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"}],"ancestors":[{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"C000591245","term":"semaglutide"},{"id":"D000077403","term":"Orlistat"},{"id":"C576188","term":"Qsymia"},{"id":"D009271","term":"Naltrexone"},{"id":"D016642","term":"Bupropion"},{"id":"C000591595","term":"bupropion hydrochloride, naltrexone hydrochoride drug combination"},{"id":"D000069450","term":"Liraglutide"}],"ancestors":[{"id":"D007783","term":"Lactones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009270","term":"Naloxone"},{"id":"D009019","term":"Morphinans"},{"id":"D053610","term":"Opiate Alkaloids"},{"id":"D000470","term":"Alkaloids"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D006572","term":"Heterocyclic Compounds, Bridged-Ring"},{"id":"D006576","term":"Heterocyclic Compounds, 4 or More Rings"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D010616","term":"Phenanthrenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}},"hasResults":true}