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Study on Efinopegdutide and Semaglutide for Adults with Non-Alcoholic Steatohepatitis (NASH) Before Cirrhosis

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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 called Non-alcoholic Steatohepatitis (NASH), which is a type of liver inflammation and damage caused by a buildup of fat in the liver. The study is testing a new treatment called efinopegdutide, also known by its code name MK-6024. This treatment is given as a solution for injection using a pre-filled syringe. The purpose of the study is to evaluate the effect of efinopegdutide compared to a placebo on the resolution of NASH without worsening liver fibrosis, which is the thickening and scarring of liver tissue, over a period of 52 weeks.

Participants in the study will receive either efinopegdutide or a placebo through subcutaneous injection, which means the injection is given under the skin. The study will last for about a year, during which the safety and tolerability of efinopegdutide will also be assessed. The main goal is to see if the treatment can help resolve NASH without making fibrosis worse. Additionally, the study will monitor any changes in body weight and any adverse events, which are unwanted effects that might occur during the study.

This trial is important for understanding how effective efinopegdutide is in treating NASH and ensuring it is safe for use. Participants will be closely monitored throughout the study to gather information on how well the treatment works and any side effects that may arise. The results of this study could provide valuable insights into new treatment options for people with NASH.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, the participant will attend an initial visit. During this visit, a healthcare professional will confirm eligibility based on specific criteria, including a liver biopsy to confirm the presence of non-alcoholic steatohepatitis (NASH).

    The participant will be informed about the study procedures, potential risks, and benefits. Consent will be obtained before proceeding.

  2. Step 2

    Randomization

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

  3. Step 3

    Treatment administration

    The study medication, efinopegdutide, or placebo will be administered as a subcutaneous injection. This means the injection is given under the skin.

    The treatment will be given regularly over a period of 52 weeks. The exact frequency and dosage will be explained by the healthcare team.

  4. Step 4

    Regular follow-up visits

    Participants will attend regular follow-up visits throughout the study. These visits are essential for monitoring health, assessing the effects of the treatment, and ensuring safety.

    During these visits, various assessments will be conducted, including physical examinations, blood tests, and questionnaires about health and well-being.

  5. Step 5

    Final assessment

    At the end of the 52-week treatment period, a final assessment will be conducted. This will include a comprehensive evaluation of the participant's health and the effects of the treatment.

    The primary goal is to determine the resolution of NASH without worsening of liver fibrosis, as well as to evaluate any changes in body weight.

  6. Step 6

    Study completion

    After the final assessment, the participant will complete the study. The healthcare team will discuss the results and any further steps or recommendations for ongoing care.

Who can join the trial?

6 criteria

  • You must have a confirmed diagnosis of Non-alcoholic steatohepatitis (NASH) through a liver biopsy. This means a small sample of your liver was taken to check for NASH.
  • Your liver biopsy must show a Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score of 4 or higher. This score measures liver damage and must include at least 1 point each for fat in the liver (steatosis), liver cell injury (ballooning), and liver inflammation.
  • Your liver biopsy must also show a NASH Clinical Research Network (CRN) fibrosis score indicating Stage 2 or 3. This score measures the amount of scar tissue in your liver.
  • You should not have a history of Type 2 diabetes mellitus (T2DM), or if you do, it must be controlled by diet or stable doses of medications that lower blood sugar.
  • You must be between the ages of 19 and 80 years old.
  • Both men and women can participate in the study.

Who cannot join the trial?

10 criteria

  • Patients with other liver diseases cannot participate.
  • Patients who have had liver transplants are not eligible.
  • Patients with a history of significant alcohol or drug abuse in the past year cannot join.
  • Patients with uncontrolled diabetes are excluded.
  • Patients with certain heart conditions are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of cancer in the past 5 years, except for some skin cancers, are excluded.
  • Patients with certain infections, like hepatitis B or C, cannot join.
  • Patients who are participating in another clinical trial are not eligible.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate are excluded.
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Investigated drugs

Efinopegdutide is a medication being studied for its potential to help people with a liver condition called nonalcoholic steatohepatitis, or NASH. This condition involves the buildup of fat in the liver, which can lead to liver damage over time. The goal of using efinopegdutide in this trial is to see if it can help reduce the liver damage caused by NASH without making the liver's condition worse. Researchers are also looking at how safe and tolerable this medication is for patients over a period of time.

What is already known about the treatment

Efinopegdutide – Efinopegdutide is administered as an injection and is currently being studied in clinical trials for its potential use in treating non-alcoholic steatohepatitis (NASH), a liver condition. The medication is in the research phase, and its effectiveness and safety are being evaluated in medical studies. It is primarily intended to help resolve NASH without worsening liver fibrosis. At the molecular level, efinopegdutide works by targeting specific pathways in the body to reduce liver inflammation and fat accumulation. It is classified as a therapeutic agent for liver diseases.

Investigated diseases

Non-alcoholic steatohepatitis – Non-alcoholic steatohepatitis (NASH) is a liver disease characterized by inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH progresses from simple fatty liver, where fat accumulates without causing harm, to a more severe form where inflammation and liver cell damage occur. Over time, this can lead to fibrosis, where scar tissue forms in the liver. If the condition continues to progress, it may result in cirrhosis, a severe scarring of the liver that can impair its function. NASH is often associated with obesity, insulin resistance, and metabolic syndrome.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502647-35-00Protocol codeMK-6024-013Estimated enrolment390 patientsSponsorMerck Sharp & Dohme LLC

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