Active — Not RecruitingPhase 2

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

United States80 participantsStarted 2024-07-12

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Change from Baseline in Liver Fat Content (LFC) at Week 28

Timeframe: Baseline and 28 weeks

Percentage of Participants Who Experienced an Adverse Event (AE)

Timeframe: Up to approximately 36 weeks

Percentage of Participants Discontinuing Study Medication Due to an AE

Timeframe: Up to approximately 28 weeks

Trial details

NCT IDNCT06465186

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-06

View on ClinicalTrials.gov More Non-alcoholic Fatty Liver Disease trials