Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Safety and Effectiveness of GSK4532990 for Adults Aged 18-65 with Alcohol-Related Liver Disease

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 condition known as alcohol-related liver disease (ALD), which affects the liver due to excessive alcohol consumption. The study will evaluate a new treatment called GSK4532990A, which is a solution for injection developed by GlaxoSmithKline. This treatment is being compared to a placebo to determine its safety and effectiveness in treating ALD.

The purpose of the study is to assess how well GSK4532990A works in reducing liver damage in adults with ALD. Participants will receive a single dose of the treatment through an injection under the skin. The study will monitor participants over a period to observe any changes in their liver condition and to ensure the treatment is safe and well-tolerated.

Throughout the study, participants will undergo various assessments to track their health and the impact of the treatment. These assessments will include regular check-ups and tests to measure liver function and overall health. The study aims to provide valuable information on the potential benefits of GSK4532990A for individuals with alcohol-related 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 visit

    Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and requirements.

    You will undergo a series of assessments to confirm your eligibility for the study. These assessments may include medical history review, physical examination, and laboratory tests.

  2. Step 2

    Safety lead-in phase

    In this phase, you will receive a single dose of the study medication, GSK4532990, administered as an injection under the skin (subcutaneous).

    The purpose of this phase is to assess the safety and tolerability of the medication. You will be monitored for any side effects or changes in your health.

  3. Step 3

    Main study period

    During the main study period, the effectiveness of GSK4532990 will be evaluated. You will continue to receive the medication as per the study protocol.

    Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits may include physical exams, blood tests, and other assessments.

  4. Step 4

    End of study

    At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

    You will have the opportunity to discuss your experience and any concerns with the study team.

Who can join the trial?

7 criteria

  • Participants must be between 18 and 70 years old at the time of screening. In South Korea, participants must be at least 19 years old.
  • Participants must have a history of alcohol consumption that is compatible with either Alcoholic Liver Disease (ALD) or Metabolic Alcoholic Liver Disease (MetALD). This means drinking patterns that fit certain criteria, such as consuming a specific number of standard drinks per day or week.
  • Female participants must not be pregnant or breastfeeding. They must either be women of nonchildbearing potential or use a highly effective contraceptive method with a failure rate of less than 1%. This method should start at least 28 days before the first dose of the study drug and continue during the study and for at least 18 weeks after the last dose. A negative pregnancy test is required within 24 hours before the first dose.
  • Participants using certain medications can join if their medication dose has been stable for at least 6 months before the study starts and is expected to remain the same during the study. These medications include incretin analogues, PPAR agonists, SGLT2 inhibitors, thyroid hormone receptor beta agonists, FXR agonists, fatty acid synthase inhibitors, FGF21 agonists, or Vitamin E at doses greater than 400 IU per day.
  • Participants must be able to give signed informed consent before any study-specific procedures. This means they understand and agree to the study's requirements and restrictions.
  • Participants must have liver cirrhosis, a condition where the liver is scarred and not functioning properly. This must be confirmed by a previous liver biopsy, medical imaging, or a compatible biochemical profile. The cirrhosis must be classified into one of the following Child-Turcotte-Pugh (CTP) classes: CTP A (Score 5-6), CTP B (Score 7-9), or CTP C (Score greater than 9).
  • Participants must be willing and able to comply with all study assessments and follow the study schedule of activities.

Who cannot join the trial?

1 criterion

  • Participants with **alcoholic liver diseases** cannot join the study. This refers to liver problems caused by drinking too much alcohol.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

GSK4532990 is a medication being tested to see if it can help people with a liver condition called steatohepatitis, which is related to alcohol use. The study is looking at how safe this medication is and how well it works. It is given as a single injection under the skin. The main goal is to see if it can improve liver health by reducing certain measurements that indicate liver damage. This medication is still being studied, so researchers are trying to find out the best dose and how it affects the liver condition over time.

What is already known about the treatment

GSK4532990 – GSK4532990 is administered as a single subcutaneous injection, meaning it is given under the skin. It is currently being studied in a Phase 2 clinical trial to determine its safety and effectiveness for treating steatohepatitis in adults with alcohol-related liver disease. The main goal is to see if it can reduce liver stiffness and improve liver function. At the molecular level, GSK4532990 works by targeting specific pathways involved in liver inflammation and damage. It is classified as a therapeutic agent for liver diseases.

Investigated diseases

Liver Diseases, Alcoholic – Alcoholic liver diseases are a group of conditions caused by excessive alcohol consumption, leading to liver damage. The progression typically begins with fatty liver, where fat accumulates in liver cells. If alcohol consumption continues, it can lead to alcoholic hepatitis, characterized by inflammation and liver cell damage. Over time, this can progress to fibrosis, where scar tissue forms, and eventually cirrhosis, which is severe scarring that impairs liver function. The liver's ability to regenerate is compromised, leading to further complications. The progression of these conditions is influenced by the amount and duration of alcohol intake.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511596-15-00Protocol code222291Estimated enrolment390 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.