{"protocolSection":{"identificationModule":{"nctId":"NCT06482112","orgStudyIdInfo":{"id":"6024-016"},"secondaryIdInfos":[{"id":"MK-6024-016","type":"OTHER","domain":"MSD"}],"organization":{"fullName":"Merck Sharp & Dohme LLC","class":"INDUSTRY"},"briefTitle":"Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)","officialTitle":"A Phase 2a Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of Efinopegdutide (MK-6024) in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease"},"statusModule":{"statusVerifiedDate":"2026-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-07-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-06-27","type":"ACTUAL"},"completionDateStruct":{"date":"2025-06-27","type":"ACTUAL"},"studyFirstSubmitDate":"2024-06-26","studyFirstSubmitQcDate":"2024-06-26","studyFirstPostDateStruct":{"date":"2024-07-01","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-05-05","resultsFirstSubmitQcDate":"2026-05-05","resultsFirstPostDateStruct":{"date":"2026-06-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-05-05","lastUpdatePostDateStruct":{"date":"2026-06-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Merck Sharp & Dohme LLC","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide."},"conditionsModule":{"conditions":["Metabolic Dysfunction-Associated Steatotic Liver Disease","Non-alcoholic Fatty Liver Disease","Nonalcoholic Fatty Liver Disease","Liver Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":124,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Efinopegdutide Q1W 10 mg","type":"ACTIVE_COMPARATOR","description":"Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.","interventionNames":["Drug: Efinopegdutide"]},{"label":"Efinopegdutide Q2W 10 mg","type":"EXPERIMENTAL","description":"Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks.","interventionNames":["Drug: Efinopegdutide"]},{"label":"Efinopegdutide Q2W 15 mg","type":"EXPERIMENTAL","description":"Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks.","interventionNames":["Drug: Efinopegdutide"]}],"interventions":[{"type":"DRUG","name":"Efinopegdutide","description":"SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm","armGroupLabels":["Efinopegdutide Q1W 10 mg","Efinopegdutide Q2W 10 mg","Efinopegdutide Q2W 15 mg"],"otherNames":["MK-6024","HM12525A","JNJ-64565111"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Relative Reduction From Baseline in Liver Fat Content at Week 28","description":"Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.","timeFrame":"Baseline and Week 28"},{"measure":"Percentage of Participants Who Experienced an Adverse Event (AE)","description":"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.","timeFrame":"Up to Week 32"},{"measure":"Percentage of Participants Who Discontinued Study Intervention Due to an AE","description":"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented.","timeFrame":"Up to Week 28"}],"secondaryOutcomes":[{"measure":"Mean Percent Change From Baseline in Body Weight at Week 28","description":"Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented.","timeFrame":"Baseline and Week 28"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has body mass index (BMI) ≥25 kg/m\\^2 (≥23 kg/m\\^2 for Asian participants) AND has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening\n* Has no history of type 2 diabetes mellitus (T2DM) OR has a history of T2DM with a glycated hemoglobin (A1C) ≤9% AND the T2DM is controlled by diet or stable doses of oral antihyperglycemic agents (AHAs)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following\n\n* Has a history or evidence of chronic liver disease other than Metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic dysfunction-associated steatohepatitis (MASH)\n* Has evidence of decompensated liver disease including, but not limited to ascites, esophageal or gastric variceal bleeding, hepatocellular carcinoma, hepatic encephalopathy, splenomegaly, or spontaneous bacterial peritonitis\n* Has a history of pancreatitis\n* Has a history of type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy.\n* Has symptomatic hyperglycemia\n* Has a history of a bariatric surgical procedure ≤5 years before Screening or a known clinically significant gastric emptying abnormality\n* Has a history of obesity with a known secondary cause\n* Has significant systemic or major illnesses, including recent (≤6 months before Screening) onset of events of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack\n* Is unable to have Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) due to: Claustrophobia to a degree that prevents tolerance of an MRI-PDFF scanning procedure. Note: Sedation is permitted, at the discretion of the investigator; Metallic implants that prevent MRI-PDFF examination; Exceeds the body habitus and/or weight limitations for the MRI scanner","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Medical Director","affiliation":"Merck Sharp and Dohme LLC","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0","city":"Chandler","state":"Arizona","zip":"85224","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0224)","city":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"facility":"Arizona Liver Health ( Site 0211)","city":"Tucson","state":"Arizona","zip":"85712","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Del Sol Research Management, LLC ( Site 0209)","city":"Tucson","state":"Arizona","zip":"85715","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"Om Research LLC ( Site 0207)","city":"Camarillo","state":"California","zip":"93012","country":"United States","geoPoint":{"lat":34.21639,"lon":-119.0376}},{"facility":"Gastroenterology and Liver Institute ( Site 0263)","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Velocity Clinical Research, Gardena ( Site 0235)","city":"Gardena","state":"California","zip":"90247","country":"United States","geoPoint":{"lat":33.88835,"lon":-118.30896}},{"facility":"Velocity Clinical Research, Huntington Park ( Site 0210)","city":"Huntington Park","state":"California","zip":"90255","country":"United States","geoPoint":{"lat":33.98168,"lon":-118.22507}},{"facility":"California Liver Research Institute ( Site 0216)","city":"Pasadena","state":"California","zip":"91105","country":"United States","geoPoint":{"lat":34.14778,"lon":-118.14452}},{"facility":"Acclaim Clinical Research ( Site 0241)","city":"San Diego","state":"California","zip":"92120","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Velocity Clinical Research, Santa Ana ( Site 0250)","city":"Santa Ana","state":"California","zip":"92704","country":"United States","geoPoint":{"lat":33.74557,"lon":-117.86783}},{"facility":"Velocity Clinical Research, Panorama City ( Site 0228)","city":"Van Nuys","state":"California","zip":"91405","country":"United States","geoPoint":{"lat":34.18667,"lon":-118.44897}},{"facility":"Excel Medical Clinical Trials ( Site 0268)","city":"Boca Raton","state":"Florida","zip":"33434","country":"United States","geoPoint":{"lat":26.35869,"lon":-80.0831}},{"facility":"AGA Clinical Trials ( Site 0274)","city":"Hialeah","state":"Florida","zip":"33012","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}},{"facility":"Neoclinical Research ( Site 0275)","city":"Hialeah","state":"Florida","zip":"33016","country":"United States","geoPoint":{"lat":25.8576,"lon":-80.27811}},{"facility":"Homestead Associates in Research, Inc. ( Site 0243)","city":"Homestead","state":"Florida","zip":"33033","country":"United States","geoPoint":{"lat":25.46872,"lon":-80.47756}},{"facility":"Floridian Clinical Research, LLC ( Site 0208)","city":"Miami Lakes","state":"Florida","zip":"33016","country":"United States","geoPoint":{"lat":25.90871,"lon":-80.30866}},{"facility":"Southeast Clinical Research Center ( Site 0223)","city":"Dalton","state":"Georgia","zip":"30720","country":"United States","geoPoint":{"lat":34.7698,"lon":-84.97022}},{"facility":"Velocity Clinical Research Rockville ( Site 0245)","city":"Rockville","state":"Maryland","zip":"20854","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"The Machuca Foundation ( Site 0218)","city":"Las Vegas","state":"Nevada","zip":"89101","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Excel Clinical Research, LLC ( Site 0200)","city":"Las Vegas","state":"Nevada","zip":"89109","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Basil Clinical ( Site 0246)","city":"Inwood","state":"New York","zip":"11096","country":"United States","geoPoint":{"lat":40.86566,"lon":-73.9268}},{"facility":"Lucas Research, Inc ( Site 0204)","city":"Morehead City","state":"North Carolina","zip":"28557","country":"United States","geoPoint":{"lat":34.72294,"lon":-76.72604}},{"facility":"Texas Clinical Research Institute ( Site 0230)","city":"Arlington","state":"Texas","zip":"76012","country":"United States","geoPoint":{"lat":32.73569,"lon":-97.10807}},{"facility":"Pinnacle Clinical Research ( Site 0203)","city":"Austin","state":"Texas","zip":"78757","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Velocity Clinical Research, Austin ( Site 0201)","city":"Austin","state":"Texas","zip":"78759","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Pinnacle Clinical Research-Corpus Christi ( Site 0267)","city":"Corpus Christi","state":"Texas","zip":"78404","country":"United States","geoPoint":{"lat":27.80058,"lon":-97.39638}},{"facility":"Zenos Clinical Research ( Site 0240)","city":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"South Texas Research Institute ( Site 0226)","city":"Edinburg","state":"Texas","zip":"78539","country":"United States","geoPoint":{"lat":26.30174,"lon":-98.16334}},{"facility":"Houston Research Institute ( Site 0221)","city":"Houston","state":"Texas","zip":"77079","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"American Research Corporation ( Site 0234)","city":"San Antonio","state":"Texas","zip":"78215","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Clinical Trials of Texas, LLC-Clinical Research ( Site 0252)","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Pinnacle Clinical Research-Clinical Research Coordination ( Site 0229)","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Impact Research Institute ( Site 0227)","city":"Waco","state":"Texas","zip":"76710","country":"United States","geoPoint":{"lat":31.54933,"lon":-97.14667}},{"facility":"Olympus Family Medicine/CCT Research ( Site 0266)","city":"Holladay","state":"Utah","zip":"84117","country":"United States","geoPoint":{"lat":40.66884,"lon":-111.82466}},{"facility":"South Ogden Family Medicine/ CCT Research ( Site 0255)","city":"South Ogden","state":"Utah","zip":"84405","country":"United States","geoPoint":{"lat":41.19189,"lon":-111.97133}},{"facility":"San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0104)","city":"Caguas","zip":"00726","country":"Puerto Rico","geoPoint":{"lat":18.23412,"lon":-66.0485}},{"facility":"Klinical Investigations Group-Clinical Research ( Site 0100)","city":"San Juan","zip":"00909","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}},{"facility":"Pan American Center for Oncology Trials - Ciudadela ( Site 0101)","city":"San Juan","zip":"00909","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Merck Clinical Trials Information","url":"https://www.merckclinicaltrials.com"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf","url":"https://externaldatasharing-msd.com/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomized to 1 of 3 efinopegdutide regimen groups: 10 mg once weekly (Q1W), 10 mg every 2 weeks (Q2W), or 15 mg Q2W.","groups":[{"id":"FG000","title":"Efinopegdutide Q1W 10 mg","description":"Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"FG001","title":"Efinopegdutide Q2W 10 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"FG002","title":"Efinopegdutide Q2W 15 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"40"},{"groupId":"FG002","numSubjects":"42"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"39"},{"groupId":"FG002","numSubjects":"42"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"35"},{"groupId":"FG002","numSubjects":"34"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"8"}]}],"dropWithdraws":[{"type":"Exclusionary laboratory result","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"Efinopegdutide Q1W 10 mg","description":"Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"BG001","title":"Efinopegdutide Q2W 10 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"BG002","title":"Efinopegdutide Q2W 15 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"42"},{"groupId":"BG003","value":"124"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.6","spread":"11.9"},{"groupId":"BG001","value":"53.4","spread":"12.6"},{"groupId":"BG002","value":"50.8","spread":"13.8"},{"groupId":"BG003","value":"50.6","spread":"12.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"77"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"47"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"79"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"44"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"11"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"107"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]}]}]},{"title":"Weight","description":"Body weight of participants","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"105.5","spread":"21.2"},{"groupId":"BG001","value":"108.4","spread":"24.4"},{"groupId":"BG002","value":"101.8","spread":"20.7"},{"groupId":"BG003","value":"105.2","spread":"22.1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Relative Reduction From Baseline in Liver Fat Content at Week 28","description":"Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.","populationDescription":"All randomized participants who received at least one dose of study intervention and have baseline data for the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"Percent Reduction","timeFrame":"Baseline and Week 28","groups":[{"id":"OG000","title":"Efinopegdutide Q1W 10 mg","description":"Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"OG001","title":"Efinopegdutide Q2W 10 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"OG002","title":"Efinopegdutide Q2W 15 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.8","lowerLimit":"60.7","upperLimit":"74.9"},{"groupId":"OG001","value":"54.4","lowerLimit":"46.8","upperLimit":"61.9"},{"groupId":"OG002","value":"42.1","lowerLimit":"34.6","upperLimit":"49.5"}]}]}]},{"type":"PRIMARY","title":"Percentage of Participants Who Experienced an Adverse Event (AE)","description":"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.","populationDescription":"All randomized participants who received at least one dose of study intervention.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Up to Week 32","groups":[{"id":"OG000","title":"Efinopegdutide Q1W 10 mg","description":"Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"OG001","title":"Efinopegdutide Q2W 10 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"OG002","title":"Efinopegdutide Q2W 15 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"83.3"},{"groupId":"OG001","value":"82.1"},{"groupId":"OG002","value":"85.7"}]}]}]},{"type":"PRIMARY","title":"Percentage of Participants Who Discontinued Study Intervention Due to an AE","description":"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented.","populationDescription":"All randomized participants who received at least one dose of study intervention.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Up to Week 28","groups":[{"id":"OG000","title":"Efinopegdutide Q1W 10 mg","description":"Participants received efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"OG001","title":"Efinopegdutide Q2W 10 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks."},{"id":"OG002","title":"Efinopegdutide Q2W 15 mg","description":"Participants received efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"42"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.1"},{"groupId":"OG001","value":"5.1"},{"groupId":"OG002","value":"9.5"}]}]}]},{"type":"SECONDARY","title":"Mean Percent Change From Baseline in Body Weight at Week 28","description":"Body weight in kilograms was measured using a standardized, digital scale. 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This allows the Sponsor to protect proprietary information and to provide comments."},"pointOfContact":{"title":"Senior Vice President, Global Clinical Development","organization":"Merck Sharp & Dohme LLC","email":"ClinicalTrialsDisclosure@msd.com","phone":"1-800-672-6372"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2024-11-04","uploadDate":"2026-05-05T08:30","filename":"Prot_SAP_000.pdf","size":828511}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D065626","term":"Non-alcoholic Fatty Liver Disease"},{"id":"D008107","term":"Liver Diseases"}],"ancestors":[{"id":"D005234","term":"Fatty Liver"},{"id":"D004066","term":"Digestive System Diseases"}]}},"hasResults":true}