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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Combination Product: Efinopegdutide
    Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
    Other names:
    • MK-6024
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.
  • Combination Product: Placebo
    Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.

Recruiting Locations

More Details

NCT ID
NCT06465186
Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center