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Study on GSK4532990 for Adults with Nonalcoholic Steatohepatitis (NASH)

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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 Nonalcoholic Steatohepatitis (NASH), which is a more severe form of Non-alcoholic Fatty Liver Disease (NAFLD). NASH involves liver inflammation and damage caused by a buildup of fat in the liver. The study is testing a new treatment called GSK4532990A, which is a solution for injection developed by GlaxoSmithKline. The purpose of the study is to evaluate whether this treatment can help improve liver health by reducing liver fibrosis (scarring) and resolving NASH in adults who have this condition.

Participants in the study will receive either the new treatment, GSK4532990A, or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The treatment will be administered through subcutaneous injection, which means it is injected under the skin. The study will last for a period of 48 weeks, during which participants will be monitored for any changes in their liver condition.

The main goal of the study is to see if GSK4532990A can lead to an improvement in liver fibrosis without worsening NASH, or if it can resolve NASH without worsening fibrosis. Participants will undergo various assessments to track their liver health throughout the study. This research aims to provide valuable insights into the potential benefits of GSK4532990A for individuals with NASH, potentially leading to new treatment options for this liver disease.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A liver biopsy is performed to assess the condition of the liver using the NASH CRN Scoring System. This helps determine the presence of Nonalcoholic Steatohepatitis (NASH) and the level of fibrosis.

  2. Step 2

    Medication administration

    Participants receive the study medication, GSK4532990, administered via subcutaneous injection. The exact dosage and frequency are determined by the study protocol.

    In addition to the study medication, participants may receive a 0.9% Sodium Chloride Injection as a placebo or control.

  3. Step 3

    Ongoing monitoring

    Regular follow-up visits are scheduled to monitor the participant's health and response to the medication. These visits include physical examinations and laboratory tests.

    Participants are required to report any side effects or changes in their health status during these visits.

  4. Step 4

    Final assessment

    After 52 weeks, a final assessment is conducted to evaluate the effectiveness of the treatment. This includes another liver biopsy to measure any changes in fibrosis and NASH resolution.

    The primary goal is to achieve improvement in liver fibrosis without worsening NASH, or to resolve NASH without worsening fibrosis.

Who can join the trial?

7 criteria

  • Participant must be between 18 and 75 years old at the time of screening.
  • Must have a Body Mass Index (BMI) of 25 or higher. BMI is a measure of body fat based on height and weight. For Asian participants, a BMI of 23 or higher is required.
  • The investigator believes that the participant has features of metabolic syndrome, and the most likely cause of liver disease is Non-alcoholic Fatty Liver Disease (NAFLD). Metabolic syndrome can include conditions like type 2 diabetes, obesity, abnormal cholesterol levels, and high blood pressure.
  • A liver biopsy must show a NAS score of 4 or more, with at least 1 point each in fat buildup, inflammation, and cell damage, and a Fibrosis score of 3. This is confirmed by a central scoring system.
  • Must be able to give signed informed consent before any study-specific procedures are done.
  • Must be able and willing to follow all study assessments.
  • If female, must not be pregnant or breastfeeding. If of childbearing potential, must use a highly effective birth control method with a failure rate of less than 1%. This should start from the time of a negative pregnancy test at screening and at least 28 days before the first study intervention, continuing during the study and for at least 18 weeks after the last intervention. A negative pregnancy test is required within 24 hours before the first dose of the study intervention.

Who cannot join the trial?

10 criteria

  • Individuals with a history of alcohol abuse or dependence cannot participate.
  • Participants with other liver diseases, such as hepatitis, are excluded.
  • People with severe heart problems are not eligible.
  • Individuals with uncontrolled diabetes cannot join the study.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Participants who have had recent major surgery are excluded.
  • People taking certain medications that affect the liver cannot participate.
  • Individuals with a history of cancer within the last five years are not eligible.
  • Participants with severe kidney problems are excluded.
  • People with certain autoimmune diseases cannot join the study.
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Investigated drugs

GSK4532990 is a medication being studied for its potential to treat nonalcoholic steatohepatitis (NASH), a liver condition. The trial aims to see if this medication can help reduce liver fibrosis (scarring) or resolve NASH in patients.

What is already known about the treatment

GSK4532990 – This medication is administered orally and is currently being studied in clinical trials for its potential to treat Non-alcoholic Steatohepatitis (NASH), a severe form of Non-alcoholic Fatty Liver Disease. It is in the Phase 2b stage of clinical trials, where its efficacy and safety are being evaluated. The main therapeutic indication is to address liver fibrosis and resolve NASH in affected individuals. At the molecular level, GSK4532990 works by inhibiting the enzyme 17 β-Hydroxysteroid Dehydrogenase type 13, which is believed to play a role in the development of liver disease. It is classified pharmacologically as an enzyme inhibitor.

Investigated diseases

Non-alcoholic Fatty Liver Disease – This condition occurs when fat builds up in the liver of people who drink little or no alcohol. It is often associated with obesity, insulin resistance, and metabolic syndrome. The disease can progress from simple fatty liver (steatosis) to non-alcoholic steatohepatitis (NASH), which involves liver inflammation and damage. Over time, NASH can lead to fibrosis, where scar tissue forms in the liver, and potentially progress to cirrhosis, a severe scarring that affects liver function. The progression of the disease is often slow and may not cause noticeable symptoms in the early stages. As the disease advances, individuals may experience fatigue, discomfort in the upper right abdomen, and other symptoms related to liver dysfunction.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507503-62-00Protocol code218672Estimated enrolment266 patientsSponsorGlaxosmithkline Research & Development Limited

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