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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Jul 12, 2024

Status verified

Feb 2026

Primary completion

Aug 6, 2026

Completion

Aug 6, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Efinopegdutide
  Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks.
• Placebo Comparator: Placebo
  Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine. Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks.

Primary Outcome Measure

Change from Baseline in Liver Fat Content (LFC) at Week 28 [ Time Frame: Baseline and 28 weeks ]

Locations (33)

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