Study S001078

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

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT06482112
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: NONE
Status: COMPLETED
Enrollment: 124
Start: 2024-07-29
Primary completion: 2025-06-27
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease; Non-alcoholic Fatty Liver Disease; Nonalcoholic Fatty Liver Disease; Liver Disease
Interventions: DRUG:Efinopegdutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:MK-6024-016

Registered primary outcomes

Mean Relative Reduction From Baseline in Liver Fat Content at Week 28 [Baseline and Week 28]
Percentage of Participants Who Experienced an Adverse Event (AE) [Up to Week 32]
Percentage of Participants Who Discontinued Study Intervention Due to an AE [Up to Week 28]

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