A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
NCT06465186 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-03-02
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
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-12
- Primary Completion
- 2026-08-06
- Completion
- 2026-08-06
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Colombia
- France
- Israel
- Japan
- Puerto Rico
- Spain
- Thailand
- United Kingdom
Study Locations
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