{"protocolSection":{"identificationModule":{"nctId":"NCT04657016","orgStudyIdInfo":{"id":"17246"},"secondaryIdInfos":[{"id":"I8F-MC-GPHM","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program","officialTitle":"Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)","acronym":"SURMOUNT-3"},"statusModule":{"statusVerifiedDate":"2024-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-03-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-04-20","type":"ACTUAL"},"completionDateStruct":{"date":"2023-05-12","type":"ACTUAL"},"studyFirstSubmitDate":"2020-12-01","studyFirstSubmitQcDate":"2020-12-01","studyFirstPostDateStruct":{"date":"2020-12-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-04-16","resultsFirstSubmitQcDate":"2024-05-08","resultsFirstPostDateStruct":{"date":"2024-05-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-05-08","lastUpdatePostDateStruct":{"date":"2024-05-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits)."},"conditionsModule":{"conditions":["Obesity","Overweight"],"keywords":["Diet","Exercise","Metabolism and Nutrition Disorder","Behavioral Modification"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":579,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tirzepatide","type":"EXPERIMENTAL","description":"Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received matching placebo SC once weekly (QW).","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["Tirzepatide"],"otherNames":["LY3298176"]},{"type":"OTHER","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight","description":"Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction","description":"Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.","timeFrame":"Week 72"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program","description":"Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.","timeFrame":"72 Weeks"},{"measure":"Percentage of Participants Who Achieve ≥10%Body Weight Reduction","description":"Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.","timeFrame":"72 Weeks"},{"measure":"Percentage of Participants Who Achieve ≥15% Body Weight Reduction","description":"Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.","timeFrame":"72 Weeks"},{"measure":"Percentage of Participants Who Achieve ≥20% Body Weight Reduction","description":"Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.","timeFrame":"72 Weeks"},{"measure":"Change From Baseline in Waist Circumference","description":"Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Body Weight","description":"Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Body Mass Index (BMI)","description":"Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Systolic Blood Pressure (SBP)","description":"Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Diastolic Blood Pressure (DBP)","description":"Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in Total Cholesterol","description":"Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol","description":"Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol","description":"Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol","description":"Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in Triglycerides","description":"Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in Free Fatty Acids","description":"Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Fasting Glucose","description":"Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Percent Change From Baseline in Fasting Insulin","description":"Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (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 determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, 72 Weeks"},{"measure":"Change From Baseline 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 determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, 72 Weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease\n* History of at least one unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Change in body weight greater than 5 kg within 3 months prior to starting study\n* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity\n* History of pancreatitis\n* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years\n* Any lifetime history of a suicide attempt","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"National Research Institute - Huntington Park","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"National Research Institute - Wilshire","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Catalina Research Institute, 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Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials. JAMA Netw Open. 2026 Mar 2;9(3):e263274. doi: 10.1001/jamanetworkopen.2026.3274."},{"pmid":"41640675","type":"DERIVED","citation":"Almandoz JP, Pickett-Blakely O, Tewksbury C, Stefanski A, Gonsahn-Bollie S, Dimitriadis GK, Murro AL, Cao D, Meng Q, Neff LM. Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials. Obes Pillars. 2026 Jan 23;17:100248. doi: 10.1016/j.obpill.2026.100248. eCollection 2026 Mar."},{"pmid":"41537305","type":"DERIVED","citation":"Wadden TA, Oquendo MA, Kushner RF, Cao D, Karanikas CA, Kechter A, Murphy MA. Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT. Obesity (Silver Spring). 2026 Mar;34(3):565-578. doi: 10.1002/oby.70122. Epub 2026 Jan 15."},{"pmid":"41187013","type":"DERIVED","citation":"Li X, Cao D, Sapin H, Wang F, Hunter Gibble T, Raibulet NK, Denning M, Kaplan LM. People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment. Obesity (Silver Spring). 2026 Jan;34(1):114-126. doi: 10.1002/oby.70067. Epub 2025 Nov 4."},{"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":"37840095","type":"DERIVED","citation":"Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)","url":"https://trials.lillytrialguide.com/en-US/trial/1ZuH7WHjpse8JDpVFSSi1I"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Plan Description:\n\nAnonymized 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":"Access Criteria:\n\nA research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"There was a 12-week lead-in period wherein the participants underwent intensive lifestyle modification program to reduce their daily caloric energy intake and increase their physical activity, followed by which they were randomized to receive Tirzepatide or Placebo.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received matching placebo subcutaneously (SC) once weekly (QW)."},{"id":"FG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. 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LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. 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Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"263"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.6","spread":"1.12"},{"groupId":"OG001","value":"15.4","spread":"1.19"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"11.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.2","ciUpperLimit":"14.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.67"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol","description":"Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"263"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.14","spread":"1.71"},{"groupId":"OG001","value":"-6.07","spread":"1.44"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-11.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-15.30","ciUpperLimit":"-7.53","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.97"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol","description":"Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"261"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.0","spread":"2.32"},{"groupId":"OG001","value":"-25.6","spread":"1.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-27.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-32.1","ciUpperLimit":"-23.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.25"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Triglycerides","description":"Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"263"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.0","spread":"2.34"},{"groupId":"OG001","value":"-25.8","spread":"1.61"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-28.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-32.3","ciUpperLimit":"-23.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.26"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Free Fatty Acids","description":"Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"263"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.0","spread":"2.95"},{"groupId":"OG001","value":"-33.1","spread":"2.20"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-21.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-28.4","ciUpperLimit":"-13.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.76"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Glucose","description":"Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Milligram per deciliter (mg/dL)","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"275"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.4","spread":"0.86"},{"groupId":"OG001","value":"-8.8","spread":"0.82"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-11.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.5","ciUpperLimit":"-8.8"}]},{"type":"SECONDARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"278"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.01","spread":"0.022"},{"groupId":"OG001","value":"-0.46","spread":"0.020"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"-0.42"}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Fasting Insulin","description":"Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percent change","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"277"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.3","spread":"4.95"},{"groupId":"OG001","value":"-39.1","spread":"2.46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Net)","paramValue":"-48.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-53.7","ciUpperLimit":"-41.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.04"}]},{"type":"SECONDARY","title":"Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (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 determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"T-score","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"231"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.6","spread":"0.39"},{"groupId":"OG001","value":"3.3","spread":"0.37"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"3.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.8","ciUpperLimit":"4.9"}]},{"type":"SECONDARY","title":"Change From Baseline 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 determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, 72 Weeks","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matching placebo SC QW."},{"id":"OG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"226"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"1.17"},{"groupId":"OG001","value":"13.9","spread":"1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"12.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"9.7","ciUpperLimit":"16.0"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to week 76","description":"All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received matching placebo SC once weekly QW.","deathsNumAffected":1,"deathsNumAtRisk":292,"seriousNumAffected":14,"seriousNumAtRisk":292,"otherNumAffected":172,"otherNumAtRisk":292},{"id":"EG001","title":"Tirzepatide","description":"Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.","deathsNumAffected":1,"deathsNumAtRisk":287,"seriousNumAffected":17,"seriousNumAtRisk":287,"otherNumAffected":230,"otherNumAtRisk":287}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Colitis microscopic","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Impaired gastric emptying","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Pancreatitis acute","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Small intestinal obstruction","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Umbilical hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Appendicitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Pyelonephritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Sepsis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Toxoplasmosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Limb injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Muscle strain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Bladder transitional cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Breast cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":292},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":287}]},{"term":"Colorectal adenoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Malignant melanoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":292},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":287}]},{"term":"Papillary thyroid cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 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