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Study of Pegozafermin Treatment for Patients with Liver Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) with compensated cirrhosis, a liver condition where inflammation and scarring occur due to metabolic problems. The study will test a new medication called pegozafermin (also known as BIO89-100) against placebo. The medication is given as a subcutaneous injection using a pre-filled syringe.

The purpose of this research is to determine if pegozafermin can help improve liver scarring and prevent the disease from getting worse in patients with MASH and cirrhosis. The study will look at how the liver tissue changes over time and track whether patients develop complications related to their liver disease.

During the study, participants will receive either pegozafermin injections or placebo. The treatment period will last for 60 months, during which patients will undergo various medical examinations to monitor their liver health. The maximum daily dose of pegozafermin that may be given is 30 milligrams, with a total maximum dose of 7200 milligrams over the entire study period.

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

    Initial treatment phase

    You will receive either pegozafermin or a placebo (substance with no active ingredients) through subcutaneous injection (injection under the skin)

    The treatment will continue for 24 months (2 years)

    Your liver condition will be regularly monitored during this period

  2. Step 2

    Liver biopsy assessment

    After 24 months of treatment, a liver biopsy will be performed

    This procedure will help determine if there has been any improvement in liver scarring compared to your initial biopsy

  3. Step 3

    Ongoing monitoring

    Regular blood tests will be conducted to measure liver function

    You will undergo FibroScan examinations (a non-invasive test to measure liver stiffness)

    ELF score (Enhanced Liver Fibrosis test) will be measured through blood samples

  4. Step 4

    Extended observation

    The study will continue until October 2031

    During this time, your liver health will be monitored for signs of disease progression

    Regular checks will be performed for complications such as fluid in the abdomen or changes in mental function

Who can join the trial?

9 criteria

  • Age between 18 and 75 years old at the time of signing the consent form
  • Must have either:
    • Type 2 diabetes diagnosed at least 3 months before screening, or
    • At least two metabolic risk factors as specified by the study doctors
    • Must have confirmed liver condition through biopsy showing:
      • Stage F4 MASH (severe scarring of the liver)
      • Compensated cirrhosis (liver damage where the liver can still perform its main functions)
      • Body Mass Index (BMI) requirements:
        • For most participants: BMI between 25.0 and 50.0
        • For Asian participants: BMI between 23.0 and 50.0
        • Both men and women can participate
        • Women who are pregnant cannot participate

Who cannot join the trial?

13 criteria

  • Presence of decompensated liver cirrhosis (severe liver damage with complications)
  • History of hepatocellular carcinoma (liver cancer)
  • Other types of liver disease besides MASH (such as viral hepatitis, autoimmune liver disease)
  • Uncontrolled type 2 diabetes (blood sugar levels consistently above target range)
  • Significant heart problems or recent cardiovascular events (like heart attack or stroke within past 6 months)
  • Severe kidney disease requiring dialysis
  • Current alcohol abuse or substance use disorder
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within past 30 days
  • Use of medications that could interfere with the study drug
  • History of allergic reactions to similar medications
  • Mental health conditions that could affect ability to follow study procedures
  • Any condition that, in the opinion of study doctors, makes participation unsafe
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Investigated drugs

Pegozafermin is a new investigational medication being studied for treating liver scarring (fibrosis) in people who have cirrhosis caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH). This medication is designed to help improve liver health and potentially reverse some of the scarring that occurs in the liver. It works differently from traditional liver medications and represents a new approach to treating this liver condition.

What is already known about the treatment

Pegozafermin – A novel investigational medication being studied in Phase 3 clinical trials for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with compensated cirrhosis. It is administered through subcutaneous injection and represents a potential therapeutic option for liver fibrosis regression. The medication is designed to target metabolic pathways involved in liver disease progression, though its complete mechanism of action at the molecular level is still being investigated through clinical research. Pegozafermin belongs to the class of metabolic modulators and is being evaluated for its ability to improve liver health in patients with cirrhosis.

Investigated diseases

Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis - A chronic liver condition characterized by fat accumulation in the liver, accompanied by inflammation and scarring (fibrosis). The disease develops due to metabolic problems, often related to obesity, diabetes, or high blood pressure. In this condition, the liver has developed significant scarring (cirrhosis) but still maintains its essential functions (compensated state). The inflammation and damage continue to progress over time, causing gradual changes in liver structure. The compensated stage means that the liver can still perform most of its vital functions despite the damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510395-31-00Protocol codeBIO89-100-132Estimated enrolment762 patientsSponsor89bio Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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