NCT06465186

A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn: * If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver * About the safety of efinopegdutide and how well people tolerate it

Conditions

• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis
• NAFLD
• Metabolic Dysfunction-associated Steatotic Liver Disease
• Metabolic Dysfunction-associated Steatohepatitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Efinopegdutide	Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
COMBINATION_PRODUCT	Placebo	Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

Timeline

• Start date: 2024-07-12
• Primary completion: 2026-08-06
• Completion: 2026-08-06
• First posted: 2024-06-18
• Last updated: 2026-03-02

Locations

68 sites across 11 countries: United States, Australia, Canada, Colombia, France, Israel, Japan, Puerto Rico, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study