Study S001833

Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

ClinicalTrials.gov record

Registration

Registration: NCT06465186
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 85
Start: 2024-07-12
Primary completion: 2026-08-03
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Non-alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; NAFLD; Metabolic Dysfunction-associated Steatotic Liver Disease; Metabolic Dysfunction-associated Steatohepatitis
Interventions: COMBINATION_PRODUCT:Efinopegdutide; COMBINATION_PRODUCT:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2024-510923-20-00; OTHER:MK-6024-017; REGISTRY:jRCT2031240217; REGISTRY:U1111-1302-7589

Registered primary outcomes

Change from Baseline in Liver Fat Content (LFC) at Week 28 [Baseline and 28 weeks]
Percentage of Participants Who Experienced an Adverse Event (AE) [Up to approximately 36 weeks]
Percentage of Participants Discontinuing Study Medication Due to an AE [Up to approximately 28 weeks]

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