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Study on the Effects of Pegozafermin for Patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis

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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 is also referred to as Nonalcoholic Steatohepatitis (NASH) with fibrosis. This condition involves the buildup of fat in the liver, leading to inflammation and scarring, which can affect liver function. The study will evaluate a treatment called Pegozafermin, which is administered as a solution for injection. Pegozafermin is being compared to a placebo to assess its effectiveness and safety in treating this liver condition.

The purpose of the study is to determine how well Pegozafermin works in improving liver health and reducing the risk of further liver damage. Participants in the study will receive either Pegozafermin or a placebo through a pre-filled syringe, which is injected under the skin. The study will last for a period of up to 36 months, with key assessments taking place at 52 weeks and at the end of the study. During this time, the effects of the treatment on liver health will be closely monitored.

Throughout the study, participants will undergo various assessments, including imaging tests like Magnetic Resonance Imaging (MRI), to measure changes in liver fat and other liver-related health markers. The study aims to provide valuable insights into the potential benefits of Pegozafermin for individuals with MASH/NASH and fibrosis, ultimately contributing to better treatment options for this condition.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, liver condition, and body mass index (BMI).

    Participants must have a biopsy-confirmed diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics. This includes a liver biopsy to evaluate the current state of liver health.

  3. Step 3

    Treatment administration

    Participants receive either pegozafermin or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous use).

    The treatment period lasts for 52 weeks, during which the effect on liver health is monitored.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular check-ups are conducted to monitor liver health and overall well-being.

    Liver fat content is assessed using magnetic resonance imaging (MRI) at week 52.

  5. Step 5

    Final assessment

    At the end of the 52-week treatment period, a final assessment is conducted to evaluate changes in liver fibrosis and overall liver health.

    The study aims to determine if there is an improvement in liver fibrosis and resolution of MASH without worsening the condition.

  6. Step 6

    Long-term follow-up

    Participants are monitored for up to 36 months to assess long-term outcomes and any progression of the disease.

    Changes in liver enzymes and the occurrence of any clinical events are recorded during this period.

Who can join the trial?

3 criteria

  • Must be a male or a non-pregnant female aged between 18 and 75 years old at the time of signing the informed consent form.
  • Must have a liver biopsy that confirms **Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH)** with **fibrosis** stage F2 or F3. Fibrosis is a condition where the liver becomes scarred. The biopsy must show a **NAS** (a score used to measure liver damage) of 4 or more, with at least 1 point in each of the following: **steatosis** (fat in the liver), **ballooning degeneration** (swelling of liver cells), and **lobular inflammation** (inflammation in the liver).
  • Must have a **Body Mass Index (BMI)** of 25.0 or more (23.0 or more for Asian participants) and less than 50.0 kg/m². BMI is a measure that uses height and weight to estimate body fat.
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Investigated drugs

Pegozafermin is a medication being studied for its potential to improve liver health in people with a condition called Metabolic Dysfunction-Associated Steatohepatitis (MASH) and fibrosis. The trial aims to see if pegozafermin can help improve liver tissue health over a period of 52 weeks and reduce the risk of negative health outcomes related to this liver condition.

What is already known about the treatment

Pegozafermin – Pegozafermin is administered via injection and is currently being studied in clinical trials for its potential use in treating Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) and Nonalcoholic Steatohepatitis (NASH) with fibrosis. It is not yet approved for general medical use, but it is being evaluated for its effectiveness and safety in improving liver health. The medication works by targeting specific pathways involved in liver metabolism and inflammation, aiming to reduce liver fat and fibrosis. Pegozafermin is classified as a therapeutic agent for liver diseases, specifically focusing on metabolic and fibrotic conditions.

Investigated diseases

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis – This disease involves the accumulation of fat in the liver not due to alcohol consumption, leading to liver inflammation and damage. Over time, the inflammation can cause scarring, known as fibrosis, which can impair liver function. MASH/NASH is often associated with metabolic conditions such as obesity, diabetes, and high cholesterol. The disease progresses as liver cells are damaged and replaced by scar tissue, which can eventually lead to more severe liver conditions. Symptoms may not be noticeable in the early stages, but as the disease progresses, individuals may experience fatigue, weakness, and abdominal discomfort. The progression of fibrosis is a key concern, as it can lead to significant liver impairment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509912-27-00Protocol codeBIO89-100-131Estimated enrolment1 350 patientsSponsor89bio Inc.

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