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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease; Non-alcoholic Fatty Liver Disease; NAFLD; Nonalcoholic Steatohepatitis; Metabolic Dysfunction-associated Steatohepatitis

Treatments: Combination Product: Efinopegdutide; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06465186

MK-6024-017 (Other Identifier)

U1111-1302-7589 (Registry Identifier)

jRCT2031240217 (Registry Identifier)

6024-017

2024-510923-20 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
• Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Has history of a liver disease other than MASH, for example, Hepatitis B or C, drug-induced liver disease, or autoimmune liver disease
• Has history of type 1 diabetes
• Had a bariatric surgical procedure less than 5 years before entry into the study
• History of pancreatitis
• Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Efinopegdutide

Experimental group

Description:

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.

Treatment:

Combination Product: Efinopegdutide

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: Placebo