{"protocolSection":{"identificationModule":{"nctId":"NCT04660643","orgStudyIdInfo":{"id":"17247"},"secondaryIdInfos":[{"id":"I8F-MC-GPHN","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss","officialTitle":"Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)","acronym":"SURMOUNT-4"},"statusModule":{"statusVerifiedDate":"2024-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-03-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-04-25","type":"ACTUAL"},"completionDateStruct":{"date":"2023-05-18","type":"ACTUAL"},"studyFirstSubmitDate":"2020-12-01","studyFirstSubmitQcDate":"2020-12-08","studyFirstPostDateStruct":{"date":"2020-12-09","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-04-25","resultsFirstSubmitQcDate":"2024-05-21","resultsFirstPostDateStruct":{"date":"2024-05-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-05-21","lastUpdatePostDateStruct":{"date":"2024-05-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits)."},"conditionsModule":{"conditions":["Obesity","Overweight"],"keywords":["Metabolism and Nutrition Disorder","Prediabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":783,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide (lead-in)","type":"EXPERIMENTAL","description":"Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.","interventionNames":["Drug: Tirzepatide"]},{"label":"Tirzepatide MTD","type":"EXPERIMENTAL","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 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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. 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Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4. Obesity (Silver Spring). 2025 Nov;33(11):2076-2092. doi: 10.1002/oby.70011. Epub 2025 Sep 3."},{"pmid":"40717199","type":"DERIVED","citation":"Gourgari E, Srivastava G, Kelly AS, Mojdami D, Cao D, Murphy MA, Karanikas CA, Lee CJ. Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials. Obesity (Silver Spring). 2025 Sep;33(9):1668-1679. doi: 10.1002/oby.24348. Epub 2025 Jul 27."},{"pmid":"39800653","type":"DERIVED","citation":"Horn DB, Kahan S, Batterham RL, Cao D, Lee CJ, Murphy M, Gonsahn-Bollie S, Chigutsa F, Stefanski A, Dunn JP. Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials. Clin Obes. 2025 Jun;15(3):e12734. doi: 10.1111/cob.12734. Epub 2025 Jan 12."},{"pmid":"38078870","type":"DERIVED","citation":"Aronne LJ, Sattar N, Horn DB, Bays HE, Wharton S, Lin WY, Ahmad NN, Zhang S, Liao R, Bunck MC, Jouravskaya I, Murphy MA; SURMOUNT-4 Investigators. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. 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weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"298"}]}],"classes":[{"title":"Total Cholesterol","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"298"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8.30","spread":"0.943"},{"groupId":"OG001","value":"2.29","spread":"0.852"}]}]},{"title":"LDL Cholesterol","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"297"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.43","spread":"1.368"},{"groupId":"OG001","value":"-3.36","spread":"1.218"}]}]},{"title":"HDL Cholesterol","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"298"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.6","spread":"1.06"},{"groupId":"OG001","value":"18.3","spread":"1.05"}]}]},{"title":"VLDL Cholesterol","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"297"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"14.7","spread":"2.32"},{"groupId":"OG001","value":"-7.8","spread":"1.77"}]}]},{"title":"Triglycerides","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"297"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"15.6","spread":"2.39"},{"groupId":"OG001","value":"-8.2","spread":"1.81"}]}]},{"title":"FFA","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"291"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"2.98"},{"groupId":"OG001","value":"-13.4","spread":"2.54"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Total Cholesterol","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-5.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.76","ciUpperLimit":"-3.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.139"},{"groupIds":["OG000","OG001"],"groupDescription":"LDL Cholesterol","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-6.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.87","ciUpperLimit":"-3.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.709"},{"groupIds":["OG000","OG001"],"groupDescription":"HDL Cholesterol","nonInferiorityType":"SUPERIORITY","pValue":"0.014","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"3.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.6","ciUpperLimit":"5.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.33"},{"groupIds":["OG000","OG001"],"groupDescription":"VLDL Cholesterol","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-19.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.0","ciUpperLimit":"-15.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.25"},{"groupIds":["OG000","OG001"],"groupDescription":"Triglycerides","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-20.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-24.9","ciUpperLimit":"-16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.27"},{"groupIds":["OG000","OG001"],"groupDescription":"FFA","nonInferiorityType":"SUPERIORITY","pValue":"0.008","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-10.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.9","ciUpperLimit":"-3.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.79"}]},{"type":"SECONDARY","title":"Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)","description":"LS mean change was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (\\< 10%, \\>= 10%) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimetre of mercury (mmHg)","timeFrame":"Randomization (Week 36), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"332"}]}],"classes":[{"title":"SBP","categories":[{"measurements":[{"groupId":"OG000","value":"8.4","spread":"0.64"},{"groupId":"OG001","value":"2.1","spread":"0.61"}]}]},{"title":"DBP","categories":[{"measurements":[{"groupId":"OG000","value":"3.2","spread":"0.44"},{"groupId":"OG001","value":"-0.4","spread":"0.42"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"SBP","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-6.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.1","ciUpperLimit":"-4.6"},{"groupIds":["OG000","OG001"],"groupDescription":"DBP","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-3.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.8","ciUpperLimit":"-2.4"}]},{"type":"SECONDARY","title":"Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score","description":"The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health \"now\" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.\n\nLS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (\\< 10%, \\>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"T-score","timeFrame":"Randomization (Week 36), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"295"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"0.32"},{"groupId":"OG001","value":"0.8","spread":"0.31"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.7","ciUpperLimit":"3.5"}]},{"type":"SECONDARY","title":"Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score","description":"The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life.\n\nLS mean was analysed by ANCOVA model with randomization + analysis Country + sex + weight loss at Week 36 (\\< 10%, \\>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had randomization and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Randomization (Week 36), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"293"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.0","spread":"0.95"},{"groupId":"OG001","value":"4.4","spread":"0.91"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"9.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.8","ciUpperLimit":"12.0"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period","description":"Percentage of Participants Who Maintain at least 80% of the Body Weight Lost During the Open-Label Lead-In Period was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment\\*Time as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had weight loss in the open label lead-in period and at least one post-randomization value for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"326"},{"groupId":"OG001","value":"332"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.50"},{"groupId":"OG001","value":"93.37"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"95.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"54.72","ciUpperLimit":"168.09"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline","description":"Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction from baseline was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment\\*Time as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-randomization values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline (Week 0) to Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"332"}]}],"classes":[{"title":"≥5% body weight reduction from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"69.00"},{"groupId":"OG001","value":"98.49"}]}]},{"title":"≥10% body weight reduction from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"44.38"},{"groupId":"OG001","value":"93.98"}]}]},{"title":"≥15% body weight reduction from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"24.01"},{"groupId":"OG001","value":"87.05"}]}]},{"title":"≥20% body weight reduction from baseline","categories":[{"measurements":[{"groupId":"OG000","value":"11.55"},{"groupId":"OG001","value":"72.59"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"≥5% body weight reduction from baseline","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"47.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.32","ciUpperLimit":"121.99"},{"groupIds":["OG000","OG001"],"groupDescription":"≥10% body weight reduction from baseline","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"71.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"34.46","ciUpperLimit":"148.39"},{"groupIds":["OG000","OG001"],"groupDescription":"≥15% body weight reduction from baseline","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"79.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"42.06","ciUpperLimit":"152.14"},{"groupIds":["OG000","OG001"],"groupDescription":"≥20% body weight reduction from baseline","nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"140.84","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"66.06","ciUpperLimit":"300.29"}]},{"type":"SECONDARY","title":"Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period","description":"Time to first occurrence of participants returning to \\>95% baseline weight for those who lost ≥5% during the open-label lead-in period.","populationDescription":"All randomized participants who received at least one dose of the study drug, lost \\>=5% of their weight in the open label period, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"weeks","timeFrame":"Randomization (Week 36) to Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"332"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were not enough events to estimate the median and confidence interval."},{"groupId":"OG001","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"There were not enough events to estimate the median and confidence interval."}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Log Rank","paramType":"Hazard Ratio (HR)","paramValue":"0.013","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.004","ciUpperLimit":"0.046","estimateComment":"Unstratified hazard ratio from Cox proportional hazard model with Baseline Weight (kg), Analysis Country, Sex, IWRS MTD at Week 36, Weight at randomization (kg) as covariates."}]},{"type":"SECONDARY","title":"Change From Baseline in BMI","description":"LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + BMI at randomization (kg/m\\^2) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg/m^2","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"332"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.6","spread":"0.16"},{"groupId":"OG001","value":"-10.0","spread":"0.15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-6.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.8","ciUpperLimit":"-6.0"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kg","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"332"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.0","spread":"0.43"},{"groupId":"OG001","value":"-27.6","spread":"0.42"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-17.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-18.8","ciUpperLimit":"-16.4"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight","description":"LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"332"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.5","spread":"0.40"},{"groupId":"OG001","value":"-26.0","spread":"0.39"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-16.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.5","ciUpperLimit":"-15.4"}]},{"type":"SECONDARY","title":"Change From Baseline in Waist Circumference","description":"LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\\< 10%, \\>= 10%) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"cm","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"329"},{"groupId":"OG001","value":"332"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.1","spread":"0.53"},{"groupId":"OG001","value":"-22.8","spread":"0.52"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-13.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.1","ciUpperLimit":"-12.2"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Glucose","description":"LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\\< 10%, \\>= 10%) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"325"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.72","spread":"0.543"},{"groupId":"OG001","value":"-10.63","spread":"0.522"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference","paramValue":"-8.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.40","ciUpperLimit":"-7.43"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c","description":"LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (\\< 10%, \\>= 10%) + treatment + time + treatment\\*time (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide 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The Physical-Functioning domain assesses limitations due to health \"now\" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.\n\nLS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (\\< 10%, \\>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"T-score","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"296"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.7","spread":"0.36"},{"groupId":"OG001","value":"6.3","spread":"0.34"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"2.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.7","ciUpperLimit":"3.7"}]},{"type":"SECONDARY","title":"Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score","description":"The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life.\n\nLS mean was analysed by ANCOVA model with baseline + analysis Country + sex + weight loss at Week 36 (\\< 10%, \\>= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of the study drug, had baseline and at least one post-baseline values for this outcome, excluding data after discontinuation of the study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline (Week 0), Week 88","groups":[{"id":"OG000","title":"Placebo","description":"Participants received weekly doses of placebo SC for 52 weeks."},{"id":"OG001","title":"Tirzepatide MTD","description":"Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"294"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.7","spread":"1.01"},{"groupId":"OG001","value":"26.0","spread":"0.97"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"ANCOVA","paramType":"LS Mean difference","paramValue":"9.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.5","ciUpperLimit":"12.0"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Week 0 to 36 for the open-label lead-in period arm, Week 36 to 92 for the double-blind study period arms.","description":"All participants who received at least one dose of the study drug. 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26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":782},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":335}]},{"term":"Covid-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Covid-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Hepatitis viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":335}]},{"term":"Peritonitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":782},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":335}]},{"term":"Clavicle fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":782},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":782},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Malnutrition","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":782},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":335},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":335}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":782},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":335},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":335}]},{"term":"Adenocarcinoma of colon","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 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