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Peptide

Efinopegdutide for Fatty Liver Disease

Phase 2
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 weeks
Awards & highlights

Summary

This trial is investigating whether a medication called efinopegdutide can effectively treat a type of liver disease caused by high liver fat levels, known as metabolic dysfunction-associated steatohepatitis (

Who is the study for?
This trial is for individuals with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH. Participants may also have type 2 diabetes that's managed by diet or medication, or they might not have diabetes at all.
What is being tested?
The study is testing efinopegdutide, a potential treatment for MASH. It aims to see if this medicine can reduce liver fat, inflammation, and scarring. The trial will compare the effects of efinopegdutide against a placebo.
What are the potential side effects?
While specific side effects are not listed here, the study seeks to evaluate the safety of efinopegdutide and how well participants tolerate it which suggests monitoring for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a stable form of liver cirrhosis due to fatty liver disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a liver condition that is not MASH, like Hepatitis or autoimmune liver disease.
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I have a history of type 1 diabetes.
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I had weight loss surgery less than 5 years ago.
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I have had pancreatitis before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Liver Fat Content (LFC) at Week 28
Percentage of Participants Discontinuing Study Medication Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)
Secondary study objectives
Change from Baseline in Enhanced Liver Fibrosis (ELF)
Change from Baseline in Fibrosis-4 index (FIB-4) at Week 28
Change from Baseline in Iron-corrected T1 (cT1) at Week 28
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EfinopegdutideExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,903 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
919 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,700 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
611 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~53 spots leftby May 2026
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