{"protocolSection":{"identificationModule":{"nctId":"NCT05822830","orgStudyIdInfo":{"id":"17203"},"secondaryIdInfos":[{"id":"I8F-MC-GPHJ","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"U1111-1283-5404","type":"OTHER","domain":"UTN Number"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities","officialTitle":"A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities","acronym":"SURMOUNT-5"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-04-21","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-11-13","type":"ACTUAL"},"completionDateStruct":{"date":"2024-11-13","type":"ACTUAL"},"studyFirstSubmitDate":"2022-09-16","studyFirstSubmitQcDate":"2023-04-10","studyFirstPostDateStruct":{"date":"2023-04-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-11-14","resultsFirstSubmitQcDate":"2025-11-14","resultsFirstPostDateStruct":{"date":"2025-11-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-14","lastUpdatePostDateStruct":{"date":"2025-11-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks."},"conditionsModule":{"conditions":["Obesity","Overweight"],"keywords":["Metabolism and Nutrition","Disorder","Prediabetes","Diet","Exercise"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Phase 3b","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":751,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"15 mg or MTD - Tirzepatide","type":"EXPERIMENTAL","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose \\[MTD (10 mg or 15 mg)\\] until Week 72.","interventionNames":["Drug: Tirzepatide"]},{"label":"2.4 mg or MTD - Semaglutide","type":"ACTIVE_COMPARATOR","description":"Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.","interventionNames":["Drug: Semaglutide"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["15 mg or MTD - Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Semaglutide","description":"Administered SC","armGroupLabels":["2.4 mg or MTD - Semaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight","description":"Percent change from baseline in body weight was reported. 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Tirzepatide compared with semaglutide in obesity disease: a subpopulation analysis applying Japan Society for the Study of Obesity criteria in the global SURMOUNT-5 trial. Curr Med Res Opin. 2026 Jul 11:1-13. doi: 10.1080/03007995.2026.2695047. Online ahead of print."},{"pmid":"41865857","type":"DERIVED","citation":"Aronne LJ, Horn DB, Kokkinos AD, Falcon BL, Wang H, Hoffmann HT, Lee CJ, Dunn JP. Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis. Am J Med. 2026 Jul;139(7):913-921. doi: 10.1016/j.amjmed.2026.03.010. Epub 2026 Mar 20."},{"pmid":"40980721","type":"DERIVED","citation":"Mamas MA, Bays H, Li R, Upadhyay N, Irani T, Senyucel C, Dunn JP, Liu-Seifert H. Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: post-hoc analysis of the SURMOUNT-5 trial. Eur Heart J Open. 2025 Sep 2;5(5):oeaf117. doi: 10.1093/ehjopen/oeaf117. eCollection 2025 Sep."},{"pmid":"40353578","type":"DERIVED","citation":"Aronne LJ, Horn DB, le Roux CW, Ho W, Falcon BL, Gomez Valderas E, Das S, Lee CJ, Glass LC, Senyucel C, Dunn JP; SURMOUNT-5 Trial Investigators. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. N Engl J Med. 2025 Jul 3;393(1):26-36. doi: 10.1056/NEJMoa2416394. Epub 2025 May 11."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities (SURMOUNT-5)","url":"https://trials.lilly.com/en-US/trial/399775"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"http://vivli.org"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"15 mg or MTD - Tirzepatide","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose \\[MTD (10 mg or 15 mg)\\] until Week 72."},{"id":"FG001","title":"2.4 mg or MTD - Semaglutide","description":"Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"375"},{"groupId":"FG001","numSubjects":"376"}]},{"type":"Received At Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"374"},{"groupId":"FG001","numSubjects":"376"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"319"},{"groupId":"FG001","numSubjects":"319"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"57"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Assigned Treatment by Mistake","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"Non-Compliance With Study Drug","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Participant was Out of the Country","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"26"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least one dose of study drug.","groups":[{"id":"BG000","title":"15 mg or MTD - 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Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.","populationDescription":"All participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, Week 72","groups":[{"id":"OG000","title":"15 mg or MTD - Tirzepatide","description":"Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72."},{"id":"OG001","title":"2.4 mg or MTD - Semaglutide","description":"Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"318"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-20.2","spread":"0.59"},{"groupId":"OG001","value":"-13.7","spread":"0.59"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"LS Mean Difference","paramValue":"-6.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.1","ciUpperLimit":"-4.9"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve ≥10% Body Weight Reduction","description":"Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.","populationDescription":"All participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 72","groups":[{"id":"OG000","title":"15 mg or MTD - 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