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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 36 weeks

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Efinopegdutide

2023

Completed Phase 1

~30

0 / 5Eligibility criteria met