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Study on Efinopegdutide for Adults with Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver condition known as Metabolic Dysfunction-Associated Steatohepatitis (MASH), which can lead to a type of liver scarring called compensated cirrhosis. The study will evaluate a treatment called efinopegdutide, also known by its code name MK-6024. This treatment is administered as a solution for injection using a pre-filled syringe. The purpose of the study is to assess the effect of efinopegdutide on reducing liver fat content and to evaluate its safety and tolerability.

Participants in the study will receive either efinopegdutide or a placebo, which is a substance with no active medication. The study will last for 28 weeks, during which the changes in liver fat content will be monitored. The study will also track any side effects experienced by participants and whether any participants discontinue the treatment due to these effects. The goal is to understand how efinopegdutide affects liver health and its safety for patients with MASH.

Throughout the study, various health indicators will be measured, including changes in liver stiffness and body weight. These measurements will help researchers determine the overall impact of efinopegdutide on liver health. The study aims to provide valuable insights into the potential benefits and risks of using efinopegdutide for treating MASH-related liver conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the medication efinopegdutide or a placebo. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

  2. Step 2

    Medication administration

    The medication, efinopegdutide, is administered as a subcutaneous injection. This means it is injected under the skin using a pre-filled syringe.

    The treatment will be given regularly over a period of 28 weeks. The exact frequency of the injections will be specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the 28-week period, the participant's liver fat content will be monitored to evaluate the effect of the treatment.

    Safety and tolerability will also be assessed by tracking any adverse events or side effects experienced during the study.

  4. Step 4

    End of treatment evaluation

    At the end of the 28 weeks, a final assessment will be conducted to measure changes in liver fat content and other health indicators.

    The study will also evaluate any changes in body weight and other specific health markers related to liver function.

Who can join the trial?

4 criteria

  • The patient must have a diagnosis of **compensated cirrhosis** due to **metabolic dysfunction-associated steatohepatitis (MASH)**. This can be confirmed by a liver tissue test or specific blood and imaging tests.
  • The patient should either have no history of **type 2 diabetes mellitus (T2DM)** or have T2DM that is well-controlled. This means their **glycated hemoglobin (A1C)** level should be 9% or lower, and their diabetes should be managed by diet or stable doses of diabetes medications.
  • The patient can be of any sex or gender and must be between 18 and 80 years old.
  • If the patient was assigned female sex at birth, they must not be pregnant or breastfeeding. If they can become pregnant, they must use a highly effective birth control method, have a negative pregnancy test, and not breastfeed during the study and for at least 5 weeks after the last dose of the study medication. Their medical history, menstrual history, and recent sexual activity will be reviewed by the study doctor.
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Investigated drugs

Efinopegdutide (MK-6024) is a medication being studied for its potential to reduce liver fat content in adults with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis. The trial aims to assess how effective this medication is in decreasing liver fat and to evaluate its safety and tolerability over a period of 28 weeks.

What is already known about the treatment

Efinopegdutide – This medication is administered via injection and is currently being studied in clinical trials for its potential use in treating metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis. It is in the investigational stage, with ongoing research to assess its efficacy and safety. Efinopegdutide is primarily indicated for reducing liver fat content in affected individuals. At the molecular level, it works by modulating pathways involved in metabolism and fat storage, aiming to improve liver health. It is classified pharmacologically as a peptide-based therapeutic agent.

Investigated diseases

Metabolic Dysfunction-Associated Steatohepatitis – This disease is characterized by the accumulation of fat in the liver, which is not caused by alcohol consumption. Over time, this fat buildup can lead to inflammation and damage to liver cells. As the condition progresses, it may cause scarring of the liver tissue, known as fibrosis. This scarring can interfere with the liver's ability to function properly. The disease is often associated with metabolic conditions such as obesity, type 2 diabetes, and high cholesterol. It is a part of a broader spectrum of liver diseases known as non-alcoholic fatty liver disease (NAFLD).
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510923-20-00Protocol codeMK-6024-017Estimated enrolment89 patientsSponsorMerck Sharp & Dohme LLC

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