{"protocolSection":{"identificationModule":{"nctId":"NCT06124807","orgStudyIdInfo":{"id":"18661"},"secondaryIdInfos":[{"id":"W8M-MC-OXA1","type":"OTHER","domain":"ISA Number"},{"id":"CWMM Master Protocol","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight","officialTitle":"A Phase 2, Parallel-Group, Double-Blind, 4-Arm Study to Investigate Weight Management With LY3305677 Compared With Placebo and in Adult Participants With Obesity or Overweight"},"statusModule":{"statusVerifiedDate":"2026-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-11-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-01-22","type":"ACTUAL"},"completionDateStruct":{"date":"2025-07-09","type":"ACTUAL"},"studyFirstSubmitDate":"2023-11-06","studyFirstSubmitQcDate":"2023-11-06","studyFirstPostDateStruct":{"date":"2023-11-09","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-02-10","resultsFirstSubmitQcDate":"2026-03-31","resultsFirstPostDateStruct":{"date":"2026-04-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-03-31","lastUpdatePostDateStruct":{"date":"2026-04-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with Mazdutide compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks."},"conditionsModule":{"conditions":["Obesity","Overweight and Obesity"],"keywords":["Incretins","Weight Loss","Overnutrition"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":179,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"3/6 Milligrams (mg) Mazdutide","type":"EXPERIMENTAL","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.","interventionNames":["Drug: Mazdutide"]},{"label":"10 mg Mazdutide","type":"EXPERIMENTAL","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.","interventionNames":["Drug: Mazdutide"]},{"label":"16 mg Mazdutide","type":"EXPERIMENTAL","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then16 mg from Weeks 20-48.","interventionNames":["Drug: Mazdutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Mazdutide","description":"Administered subcutaneous (SC)","armGroupLabels":["10 mg Mazdutide","16 mg Mazdutide","3/6 Milligrams (mg) Mazdutide"],"otherNames":["LY3305677"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight at Week 32","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32"}],"secondaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight at Week 48","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 48"},{"measure":"Change From Baseline in Body Weight","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction","description":"Mean percentage of participants who achieve ≥5% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction","description":"Mean percentage of participants who achieve ≥10% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Change From Baseline in Body Mass Index (BMI)","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)","description":"Blood samples were tested to determine if a participant reacted to Mazdutide by producing anti-Mazdutide antibodies. A participant is TE ADA evaluable if there is at least one non-missing test result for ADA for each of the baseline period and the postbaseline period. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the subject is TE ADA+ if there is at least one postbaseline result of ADA Present with titer \\>=1:20.","timeFrame":"Baseline up to week 56"},{"measure":"Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State","description":"PK samples were analyzed using a population PK approach to estimate AUC at steady state. Data presented are Geometric mean with 90% prediction interval.","timeFrame":"Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24"},{"measure":"PK: Maximum Concentration (Cmax) of Mazdutide at Steady State","description":"PK samples were analyzed using a population PK approach to estimate Cmax at steady state. Data presented are Geometric mean with 90% prediction interval.","timeFrame":"Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24"},{"measure":"Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = Treatment\\*Time + log(Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\\*Time + log (Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\\*Time + log (Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\\*Time + log (Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC","description":"mean Percentage of participants with baseline liver fat content (LFC) \\>= 5% who achieved \\>30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","timeFrame":"Baseline, Week 32, Week 48"},{"measure":"Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC","description":"Mean Percentage of participants with baseline liver fat content (LFC) \\>=10% who achieved \\>30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","timeFrame":"Baseline, Week 32, Week 48"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nW8M-MC-OXA1:\n\n* Are males and females who agree to abide by the reproductive and contraceptive requirements\n\nW8M-MC-CWMM:\n\n* Have a BMI ≥27 kilograms per square meter (kg/m²)\n\nExclusion Criteria:\n\nW8M-MC-OXA1:\n\n* Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.\n* Have any of the following cardiovascular conditions within 6 months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure (CHF).\n* Have a history of New York Heart Association (NYHA) Functional Classification I-IV CHF.\n* Participants with hypertension who do not have well-controlled blood pressure (BP) (\\>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening.\n* Have a history of acute or chronic pancreatitis.\n\nNote: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.\n\nCWMM:\n\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening.\n* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.\n* Have poorly controlled hypertension.\n* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.\n* Have a history of symptomatic gallbladder disease within the past 2 years.\n* Have a lifetime history of suicide attempts.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 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":"The Institute for Liver Health II dba Arizona Clinical Trials - Mesa","city":"Chandler","state":"Arizona","zip":"85225","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"Headlands Research - Scottsdale","city":"Scottsdale","state":"Arizona","zip":"85260","country":"United States","geoPoint":{"lat":33.50921,"lon":-111.89903}},{"facility":"The Institute for Liver Health II dba Arizona Liver Health-Tucson","city":"Tucson","state":"Arizona","zip":"85712","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Velocity Clinical Research, Huntington Park","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"Peninsula Research Associates","city":"Rolling Hills Estates","state":"California","zip":"90274","country":"United States","geoPoint":{"lat":33.78779,"lon":-118.35813}},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","zip":"94598","country":"United States","geoPoint":{"lat":37.90631,"lon":-122.06496}},{"facility":"Northeast Research Institute (NERI)","city":"Fleming Island","state":"Florida","zip":"32003","country":"United States","geoPoint":{"lat":30.0933,"lon":-81.71898}},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"Charter Research - Winter Park","city":"Orlando","state":"Florida","zip":"32803","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Charter Research - Lady Lake","city":"The Villages","state":"Florida","zip":"32162","country":"United States","geoPoint":{"lat":28.93408,"lon":-81.95994}},{"facility":"Pacific Diabetes & Endocrine Center","city":"Honolulu","state":"Hawaii","zip":"96817","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"Great Lakes Clinical Trials - Andersonville","city":"Chicago","state":"Illinois","zip":"60640","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Great Lakes Clinical Trials - Ravenswood","city":"Chicago","state":"Illinois","zip":"60640","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"Cotton O'Neil Diabetes & Endocrinology","city":"Topeka","state":"Kansas","zip":"66606","country":"United States","geoPoint":{"lat":39.04833,"lon":-95.67804}},{"facility":"L-MARC Research Center","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Knownwell","city":"Needham","state":"Massachusetts","zip":"02492","country":"United States","geoPoint":{"lat":42.28343,"lon":-71.23283}},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","zip":"63303","country":"United States","geoPoint":{"lat":38.80033,"lon":-90.62651}},{"facility":"Las Vegas Medical Research","city":"Las Vegas","state":"Nevada","zip":"89128","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Dent Neurologic Institute","city":"Amherst","state":"New York","zip":"14226","country":"United States","geoPoint":{"lat":42.97839,"lon":-78.79976}},{"facility":"North Suffolk Neurology","city":"Port Jefferson Station","state":"New York","zip":"11776","country":"United States","geoPoint":{"lat":40.92538,"lon":-73.04733}},{"facility":"Lucas Research, Inc.","city":"New Bern","state":"North Carolina","zip":"28562","country":"United States","geoPoint":{"lat":35.10849,"lon":-77.04411}},{"facility":"CTI Clinical Research Center","city":"Cincinnati","state":"Ohio","zip":"45212","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Quality Medical Research","city":"Nashville","state":"Tennessee","zip":"37211","country":"United States","geoPoint":{"lat":36.16589,"lon":-86.78444}},{"facility":"IMA Clinical Research Austin","city":"Austin","state":"Texas","zip":"78745","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Velocity Clinical Research, Dallas","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"PlanIt Research, PLLC","city":"Houston","state":"Texas","zip":"77079","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Tekton Research - Fredericksburg Road","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Spectrum Medical, Inc.","city":"Danville","state":"Virginia","zip":"24541","country":"United States","geoPoint":{"lat":36.58597,"lon":-79.39502}},{"facility":"Central Washington Health Services Association d/b/a Confluence Health","city":"Wenatchee","state":"Washington","zip":"98801","country":"United States","geoPoint":{"lat":47.42346,"lon":-120.31035}}]},"referencesModule":{"references":[{"pmid":"42628555","type":"DERIVED","citation":"Hsia SH, Bays HE, Billings LK, Weideman AMK, Mather KJ, Coskun T, Haupt A, Thomas MK, Tham LS, Calderon B, Ni W, De Araujo OFG. Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. Lancet Diabetes Endocrinol. 2026 Aug 21:S2213-8587(26)00160-9. doi: 10.1016/S2213-8587(26)00160-9. Online ahead of print."}],"seeAlsoLinks":[{"label":"A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight","url":"https://trials.lilly.com/en-US/trial/434975"}]},"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":"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":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"FG001","title":"3/6 Milligrams (mg) Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"FG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"FG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"48"},{"groupId":"FG003","numSubjects":"51"}]},{"type":"Safety Population (Participants Who Are Exposed to at Least One Dose of Study Intervention)","achievements":[{"groupId":"FG000","numSubjects":"47"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"47"},{"groupId":"FG003","numSubjects":"51"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"37"},{"groupId":"FG003","numSubjects":"34"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"17"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Inadvertent enrollment","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Met early discontinuation criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"Schedule conflict","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Did not return for the scheduled safety follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"BG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"BG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"BG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"48"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"179"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.7","spread":"12.5"},{"groupId":"BG001","value":"48.6","spread":"13.8"},{"groupId":"BG002","value":"48.4","spread":"10.1"},{"groupId":"BG003","value":"48.3","spread":"13.3"},{"groupId":"BG004","value":"47.7","spread":"12.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"32"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"118"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"18"},{"groupId":"BG004","value":"61"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"41"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"38"},{"groupId":"BG004","value":"135"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"3"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"9"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"34"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"38"},{"groupId":"BG004","value":"125"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"6"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"4"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"48"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"179"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Kilograms (Kg)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"103.1","spread":"21.20"},{"groupId":"BG001","value":"109.8","spread":"17.71"},{"groupId":"BG002","value":"108.5","spread":"21.70"},{"groupId":"BG003","value":"109.7","spread":"20.67"},{"groupId":"BG004","value":"107.6","spread":"20.63"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percent Change From Baseline in Body Weight at Week 32","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 32","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.85","spread":"0.787"},{"groupId":"OG001","value":"-7.33","spread":"0.937"},{"groupId":"OG002","value":"-15.6","spread":"0.744"},{"groupId":"OG003","value":"-18.1","spread":"0.965"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Body Weight at Week 48","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.047","spread":"1.059"},{"groupId":"OG001","value":"-10.54","spread":"1.498"},{"groupId":"OG002","value":"-19.2","spread":"1.076"},{"groupId":"OG003","value":"-22.3","spread":"1.424"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms (Kg)","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"51"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-0.98","spread":"0.882"},{"groupId":"OG001","value":"-7.79","spread":"1.011"},{"groupId":"OG002","value":"-16.1","spread":"0.779"},{"groupId":"OG003","value":"-19.2","spread":"1.037"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"-0.15","spread":"1.195"},{"groupId":"OG001","value":"-11.15","spread":"1.601"},{"groupId":"OG002","value":"-19.7","spread":"1.127"},{"groupId":"OG003","value":"-23.9","spread":"1.542"}]}]}]},{"type":"SECONDARY","title":"Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction","description":"Mean percentage of participants who achieve ≥5% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"51"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"23.97","spread":"6.99"},{"groupId":"OG001","value":"67.64","spread":"8.70"},{"groupId":"OG002","value":"96.10","spread":"3.57"},{"groupId":"OG003","value":"92.23","spread":"4.30"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"25.96","spread":"7.13"},{"groupId":"OG001","value":"74.77","spread":"8.27"},{"groupId":"OG002","value":"95.91","spread":"3.46"},{"groupId":"OG003","value":"91.90","spread":"4.95"}]}]}]},{"type":"SECONDARY","title":"Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction","description":"Mean percentage of participants who achieve ≥10% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"51"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"8.73","spread":"4.53"},{"groupId":"OG001","value":"45.43","spread":"9.18"},{"groupId":"OG002","value":"85.95","spread":"5.67"},{"groupId":"OG003","value":"77.08","spread":"6.45"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"13.77","spread":"5.81"},{"groupId":"OG001","value":"57.86","spread":"9.14"},{"groupId":"OG002","value":"83.97","spread":"5.70"},{"groupId":"OG003","value":"80.73","spread":"6.43"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Body Mass Index (BMI)","description":"Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\\*Time + Strata\\*Time + Treatment\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram per square metre (kg/m^2)","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"51"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.305"},{"groupId":"OG001","value":"-2.84","spread":"0.376"},{"groupId":"OG002","value":"-5.81","spread":"0.281"},{"groupId":"OG003","value":"-6.86","spread":"0.372"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"-0.017","spread":"0.430"},{"groupId":"OG001","value":"-4.07","spread":"0.609"},{"groupId":"OG002","value":"-7.15","spread":"0.409"},{"groupId":"OG003","value":"-8.53","spread":"0.559"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)","description":"Blood samples were tested to determine if a participant reacted to Mazdutide by producing anti-Mazdutide antibodies. A participant is TE ADA evaluable if there is at least one non-missing test result for ADA for each of the baseline period and the postbaseline period. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the subject is TE ADA+ if there is at least one postbaseline result of ADA Present with titer \\>=1:20.","populationDescription":"All participants who are exposed to at least one dose of study intervention and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"timeFrame":"Baseline up to week 56","groups":[{"id":"OG000","title":"Placebo","description":"Participants received matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 Milligrams (mg) Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"11"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State","description":"PK samples were analyzed using a population PK approach to estimate AUC at steady state. Data presented are Geometric mean with 90% prediction interval.","populationDescription":"All randomized participants who had evaluable PK data for this outcome. Per protocol, PK data was pre-specified to be analyzed separately by individual target doses.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"nanogram*hour per milliliter (ng*h/mL)","timeFrame":"Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24","groups":[{"id":"OG000","title":"3 mg Mazdutide","description":"All Participants who received once-weekly subcutaneous 3 mg Mazdutide from Weeks 4-31."},{"id":"OG001","title":"6 mg Mazdutide","description":"All Participants who received once-weekly subcutaneous 6 mg Mazdutide from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93800","lowerLimit":"44800","upperLimit":"199000"},{"groupId":"OG001","value":"190000","lowerLimit":"90600","upperLimit":"404000"},{"groupId":"OG002","value":"340000","lowerLimit":"158000","upperLimit":"758000"},{"groupId":"OG003","value":"537000","lowerLimit":"240000","upperLimit":"1210000"}]}]}]},{"type":"SECONDARY","title":"PK: Maximum Concentration (Cmax) of Mazdutide at Steady State","description":"PK samples were analyzed using a population PK approach to estimate Cmax at steady state. Data presented are Geometric mean with 90% prediction interval.","populationDescription":"All randomized participants who had evaluable PK data for this outcome. Per protocol, PK data was pre-specified to be analyzed separately by individual target doses.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"nanogram per milliliter (ng/mL)","timeFrame":"Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24","groups":[{"id":"OG000","title":"3 mg Mazdutide","description":"All Participants who received once-weekly subcutaneous 3 mg Mazdutide from Weeks 4-31."},{"id":"OG001","title":"6 mg Mazdutide","description":"All Participants who received once-weekly subcutaneous 6 mg Mazdutide from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"694","lowerLimit":"356","upperLimit":"1330"},{"groupId":"OG001","value":"1420","lowerLimit":"735","upperLimit":"2880"},{"groupId":"OG002","value":"2530","lowerLimit":"1290","upperLimit":"5380"},{"groupId":"OG003","value":"4020","lowerLimit":"2000","upperLimit":"8020"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = Treatment\\*Time + log(Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of liver fat content","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"31"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-1.62","spread":"0.770"},{"groupId":"OG001","value":"-6.15","spread":"0.615"},{"groupId":"OG002","value":"-7.78","spread":"0.462"},{"groupId":"OG003","value":"-7.91","spread":"0.548"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"-1.35","spread":"0.872"},{"groupId":"OG001","value":"-7.81","spread":"0.444"},{"groupId":"OG002","value":"-8.07","spread":"0.448"},{"groupId":"OG003","value":"-7.74","spread":"0.670"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\\*Time + log (Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"31"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-14.1","spread":"6.70"},{"groupId":"OG001","value":"-53.5","spread":"5.35"},{"groupId":"OG002","value":"-67.7","spread":"4.02"},{"groupId":"OG003","value":"-68.8","spread":"4.76"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"-11.7","spread":"7.58"},{"groupId":"OG001","value":"-68.0","spread":"3.86"},{"groupId":"OG002","value":"-70.2","spread":"3.90"},{"groupId":"OG003","value":"-67.4","spread":"5.83"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\\*Time + log (Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of liver fat content","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"18"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-4.3","spread":"1.48"},{"groupId":"OG001","value":"-9.3","spread":"1.43"},{"groupId":"OG002","value":"-13.8","spread":"0.49"},{"groupId":"OG003","value":"-12.8","spread":"1.06"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"-4.6","spread":"1.67"},{"groupId":"OG001","value":"-12.4","spread":"0.95"},{"groupId":"OG002","value":"-13.9","spread":"0.62"},{"groupId":"OG003","value":"-12.6","spread":"1.40"}]}]}]},{"type":"SECONDARY","title":"Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%","description":"Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\\*Time + log (Baseline)\\*Time + Strata\\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\\<=30, \\>30 kg/m\\^2).","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percent change","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"18"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"-24.7","spread":"8.51"},{"groupId":"OG001","value":"-53.4","spread":"8.26"},{"groupId":"OG002","value":"-79.5","spread":"2.80"},{"groupId":"OG003","value":"-73.6","spread":"6.08"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"-26.3","spread":"9.63"},{"groupId":"OG001","value":"-71.2","spread":"5.45"},{"groupId":"OG002","value":"-80.2","spread":"3.55"},{"groupId":"OG003","value":"-72.3","spread":"8.09"}]}]}]},{"type":"SECONDARY","title":"Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC","description":"mean Percentage of participants with baseline liver fat content (LFC) \\>= 5% who achieved \\>30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"31"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"24.93","spread":"8.67"},{"groupId":"OG001","value":"73.97","spread":"10.29"},{"groupId":"OG002","value":"84.93","spread":"6.39"},{"groupId":"OG003","value":"83.40","spread":"7.41"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"30.04","spread":"9.16"},{"groupId":"OG001","value":"87.73","spread":"8.58"},{"groupId":"OG002","value":"85.70","spread":"7.19"},{"groupId":"OG003","value":"84.23","spread":"8.82"}]}]}]},{"type":"SECONDARY","title":"Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC","description":"Mean Percentage of participants with baseline liver fat content (LFC) \\>=10% who achieved \\>30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.","populationDescription":"All randomized participants who were evaluable for this outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 32, Week 48","groups":[{"id":"OG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48."},{"id":"OG001","title":"3/6 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48."},{"id":"OG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48."},{"id":"OG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"18"}]}],"classes":[{"title":"Week 32","categories":[{"measurements":[{"groupId":"OG000","value":"38.57","spread":"12.98"},{"groupId":"OG001","value":"71.95","spread":"14.13"},{"groupId":"OG002","value":"99.71","spread":"1.92"},{"groupId":"OG003","value":"92.04","spread":"7.73"}]}]},{"title":"Week 48","categories":[{"measurements":[{"groupId":"OG000","value":"36.82","spread":"13.36"},{"groupId":"OG001","value":"86.64","spread":"10.88"},{"groupId":"OG002","value":"90.46","spread":"7.93"},{"groupId":"OG003","value":"78.36","spread":"12.46"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline up to Week 56","description":"All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48","deathsNumAffected":0,"deathsNumAtRisk":47,"seriousNumAffected":1,"seriousNumAtRisk":47,"otherNumAffected":34,"otherNumAtRisk":47},{"id":"EG001","title":"3/6 Milligrams (mg) Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.","deathsNumAffected":0,"deathsNumAtRisk":32,"seriousNumAffected":1,"seriousNumAtRisk":32,"otherNumAffected":29,"otherNumAtRisk":32},{"id":"EG002","title":"10 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.","deathsNumAffected":0,"deathsNumAtRisk":47,"seriousNumAffected":1,"seriousNumAtRisk":47,"otherNumAffected":37,"otherNumAtRisk":47},{"id":"EG003","title":"16 mg Mazdutide","description":"Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.","deathsNumAffected":0,"deathsNumAtRisk":51,"seriousNumAffected":2,"seriousNumAtRisk":51,"otherNumAffected":45,"otherNumAtRisk":51}],"seriousEvents":[{"term":"Cholecystitis acute","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Hepatic necrosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Epilepsy","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Nephrolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]}],"otherEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":6,"numAffected":4,"numAtRisk":51}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":47},{"groupId":"EG003","numEvents":10,"numAffected":6,"numAtRisk":51}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":51}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":47},{"groupId":"EG001","numEvents":8,"numAffected":7,"numAtRisk":32},{"groupId":"EG002","numEvents":17,"numAffected":14,"numAtRisk":47},{"groupId":"EG003","numEvents":21,"numAffected":19,"numAtRisk":51}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":47},{"groupId":"EG001","numEvents":15,"numAffected":9,"numAtRisk":32},{"groupId":"EG002","numEvents":16,"numAffected":12,"numAtRisk":47},{"groupId":"EG003","numEvents":29,"numAffected":13,"numAtRisk":51}]},{"term":"Diverticulum intestinal","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":6,"numAffected":5,"numAtRisk":47},{"groupId":"EG003","numEvents":5,"numAffected":4,"numAtRisk":51}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":5,"numAffected":4,"numAtRisk":51}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":32},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":15,"numAffected":12,"numAtRisk":47},{"groupId":"EG001","numEvents":21,"numAffected":14,"numAtRisk":32},{"groupId":"EG002","numEvents":36,"numAffected":22,"numAtRisk":47},{"groupId":"EG003","numEvents":89,"numAffected":34,"numAtRisk":51}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":32},{"groupId":"EG002","numEvents":9,"numAffected":6,"numAtRisk":47},{"groupId":"EG003","numEvents":55,"numAffected":24,"numAtRisk":51}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":8,"numAffected":6,"numAtRisk":32},{"groupId":"EG002","numEvents":25,"numAffected":11,"numAtRisk":47},{"groupId":"EG003","numEvents":16,"numAffected":13,"numAtRisk":51}]},{"term":"Injection site reaction","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":5,"numAffected":2,"numAtRisk":51}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":51}]},{"term":"Hepatic cyst","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":51}]},{"term":"Hepatic steatosis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":32},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Bacterial vaginosis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":31},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":33}]},{"term":"Covid-19","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG003","numEvents":8,"numAffected":8,"numAtRisk":51}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":51}]},{"term":"Gastrointestinal viral infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":7,"numAtRisk":47},{"groupId":"EG001","numEvents":7,"numAffected":6,"numAtRisk":32},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":47},{"groupId":"EG003","numEvents":6,"numAffected":6,"numAtRisk":51}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":32},{"groupId":"EG002","numEvents":7,"numAffected":6,"numAtRisk":47},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":51}]},{"term":"Gamma-glutamyltransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":32},{"groupId":"EG002","numEvents":4,"numAffected":3,"numAtRisk":47},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":51}]},{"term":"Dehydration","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":51}]},{"term":"Glucose tolerance impaired","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":47},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Increased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":51}]},{"term":"Vitamin b12 deficiency","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":5,"numAffected":4,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":51}]},{"term":"Musculoskeletal chest pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Prostate cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":16},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":16},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":18}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG003","numEvents":10,"numAffected":9,"numAtRisk":51}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":5,"numAtRisk":47},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":32},{"groupId":"EG002","numEvents":5,"numAffected":4,"numAtRisk":47},{"groupId":"EG003","numEvents":5,"numAffected":5,"numAtRisk":51}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Renal cyst","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":51}]},{"term":"Erectile dysfunction","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":16},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":16},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":18}]},{"term":"Prostatic mass","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":16},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":16},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":18}]},{"term":"Prostatomegaly","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":16},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":16},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":18}]},{"term":"Rhinorrhoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":51}]},{"term":"Sensitive skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":32},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":47},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":51}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 28.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":32},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG003","numEvents":4,"numAffected":3,"numAtRisk":51}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"08005455979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2024-10-28","uploadDate":"2026-01-11T21:39","filename":"Prot_000.pdf","size":4723290},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2025-05-30","uploadDate":"2026-01-11T21:41","filename":"SAP_001.pdf","size":1264780}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09","removedCountries":["Argentina"],"submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2026-03-02","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D050177","term":"Overweight"},{"id":"D015431","term":"Weight Loss"},{"id":"D044343","term":"Overnutrition"}],"ancestors":[{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D001836","term":"Body Weight Changes"}]},"interventionBrowseModule":{"meshes":[{"id":"C000719829","term":"mazdutide"}]}},"hasResults":true}