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Study on Efruxifermin for Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

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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 the effects of a treatment called Efruxifermin on a liver condition known as Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). These conditions are types of liver disease that occur when fat builds up in the liver, leading to inflammation and damage. The study aims to evaluate how well Efruxifermin works in people with a specific stage of liver disease called compensated cirrhosis, which means the liver is scarred but still able to perform its functions.

Participants in the study will receive either Efruxifermin or a placebo, which is a substance with no active medication. The treatment is given as a solution for injection under the skin. The study will monitor participants over a period to see if Efruxifermin can improve liver health by reducing scarring and preventing the disease from getting worse. The main goal is to see if the treatment can help people live longer without experiencing serious liver-related problems.

The study will last for several years, with regular check-ups to assess the health of the liver and overall well-being of the participants. The researchers will look at various health markers, including liver function tests and other indicators of liver health, to determine the effectiveness of Efruxifermin compared to the placebo. This research is important for understanding how to better treat liver diseases like NASH and MASH and improve the quality of life for those affected.

The research process

The trial runs in 5 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, participants will be randomly assigned to receive either the investigational medication efruxifermin or a placebo. A placebo is a substance with no active medication, used to compare the effects of the investigational drug.

    The study is double-blind, meaning neither the participants nor the researchers know who is receiving the investigational medication or the placebo.

  2. Step 2

    Medication administration

    Participants will receive the medication as a solution for injection under the skin, known as a subcutaneous injection.

    The dosage and frequency of the injections will be determined by the study protocol and communicated to participants by the study team.

  3. Step 3

    Regular check-ups

    Participants will attend regular check-ups to monitor their health and the effects of the medication. These check-ups will include physical examinations, blood tests, and other necessary assessments.

    The study team will provide specific instructions on when and where these check-ups will take place.

  4. Step 4

    Monitoring and reporting

    Participants are required to report any side effects or changes in their health to the study team immediately. This is crucial for ensuring participant safety and the integrity of the study.

    The study team will provide contact information and instructions on how to report any issues.

  5. Step 5

    End of study participation

    At the end of the study, participants will undergo a final evaluation to assess their health and the effects of the medication.

    Participants will be informed about the results of the study and any further steps if necessary.

Who can join the trial?

10 criteria

  • Must be a male or non-pregnant, non-lactating female between 18-80 years old.
  • Must be willing and able to give written informed consent before any study procedures.
  • If female and capable of having children, must have a negative pregnancy test at the start of the study.
  • If capable of having children and engaging in heterosexual intercourse, must agree to use specified methods of contraception.
  • Must have a history or presence of type 2 diabetes or at least two of the following: obesity, abnormal cholesterol levels (dyslipidemia), high blood pressure, or high fasting blood sugar.
  • Must have a body mass index (BMI) of 25 or higher. BMI is a measure of body fat based on height and weight.
  • For certain participants, must have a FibroScan® test or ELF score to assess liver stiffness.
  • For certain participants, must have a biopsy-proven compensated cirrhosis due to NASH/MASH, with specific scores on a liver biopsy.
  • Must have specific laboratory test results within certain ranges, such as albumin, kidney function, blood sugar levels, and others.
  • Must have stable liver enzyme levels (ALT and AST) without significant worsening before the study starts.

Who cannot join the trial?

10 criteria

  • Patients with other serious liver diseases cannot participate.
  • Patients who have had a liver transplant are not eligible.
  • Patients with uncontrolled diabetes, which means their blood sugar levels are not stable, cannot join the study.
  • Patients with a history of significant alcohol or drug abuse in the past year are excluded.
  • Patients with certain heart conditions, such as heart failure or recent heart attack, cannot participate.
  • Patients with active cancer, except for some skin cancers, are not eligible.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients who are participating in another clinical trial are excluded.
  • Patients with severe kidney disease are not eligible.
  • Patients with certain infections, like hepatitis B or C, are excluded.
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Investigated drugs

Efruxifermin is a medication being studied for its potential to help people with a liver condition called nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). These conditions can lead to a serious liver problem known as cirrhosis, where the liver becomes scarred and doesn't work as well as it should. Efruxifermin is being tested to see if it can improve liver health by reducing the scarring and improving liver function. The goal is to see if this medication can help people live longer and have better liver health by preventing or reducing the damage caused by these liver conditions.

What is already known about the treatment

Efruxifermin – Efruxifermin is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its potential benefits in treating liver conditions. It is primarily being investigated for its effectiveness in managing Non-Alcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), which are liver diseases characterized by inflammation and fat accumulation. At the molecular level, Efruxifermin works by mimicking a natural protein in the body that helps regulate metabolism and reduce liver fat. It is classified as a metabolic modulator, aiming to improve liver health and function.

Investigated diseases

  • Non-Alcoholic Steatohepatitis (NASH)

    Non-Alcoholic Steatohepatitis is a liver disease characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH progresses from simple fatty liver (steatosis) to more severe liver damage. Over time, the inflammation and liver cell damage can lead to fibrosis, which is the formation of scar tissue in the liver. If fibrosis continues to progress, it can result in cirrhosis, where the liver becomes severely scarred and its function is impaired. NASH is often associated with obesity, insulin resistance, and metabolic syndrome.

  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)

    Metabolic Dysfunction-Associated Steatohepatitis is a liver condition similar to Non-Alcoholic Steatohepatitis, characterized by fat accumulation, inflammation, and liver cell damage. It is associated with metabolic dysfunctions such as obesity, type 2 diabetes, and dyslipidemia. MASH progresses from simple steatosis to more severe liver damage, including inflammation and fibrosis. The ongoing liver damage can lead to the development of cirrhosis, where the liver becomes heavily scarred. This condition is part of a broader spectrum of liver diseases linked to metabolic syndrome. MASH highlights the role of metabolic dysfunction in the progression of liver disease.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512895-36-00Protocol codeAK-US-001-0106Estimated enrolment2 180 patientsSponsorAkero Therapeutics Inc.

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