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GSK4532990 for adults with alcohol-related liver disease

A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)

Phase 2 Interventional GlaxoSmithKline · NCT06613698

This trial will test whether GSK4532990 is safe and helps adults aged 18 to 70 who have alcohol-related liver disease compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment393 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations131 sites (Chandler, Arizona and 130 other locations)
Trial IDNCT06613698 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, placebo-controlled trial of GSK4532990 in adults aged 18 to 70 with alcohol-related liver disease and advanced chronic liver disease. Participants will receive either GSK4532990 or placebo and be followed for safety and clinical and biochemical measures of liver health. Key eligibility includes a history of alcohol consumption consistent with alcohol-related liver disease, stability on concomitant medications, and meeting predefined laboratory criteria; participants with organ system failure per NACSELD are excluded. The trial is being conducted at GSK investigational sites in Arizona with outcomes focused on tolerability and signals of benefit on liver-related endpoints.

Who should consider this trial

Good fit: Adults 18 to 70 with alcohol-related liver disease and advanced chronic liver disease who can consent, meet lab and medication stability requirements, and pass pre-specified inclusion criteria.

Not a fit: People who meet definitions of organ system failure, who exceed predefined abnormal laboratory thresholds, or who fall outside the age or other eligibility limits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, GSK4532990 could slow or improve liver injury and symptoms in people with alcohol-related liver disease.

How similar studies have performed: Previous drugs targeting inflammation or fibrosis in alcohol-related liver disease and steatohepatitis have shown mixed results, so this approach builds on prior work but is not yet established as a breakthrough.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Capable of giving signed informed consent prior to the performance of any study-specific procedures.
* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
* In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.
* A female participant is eligible to participate after meeting additional pre-defined criteria.
* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
* Participant has advanced chronic liver disease

Exclusion Criteria:

* Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
* Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
* Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
* Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants).
* Chronic or acute, including partial, known portal vein thrombosis.
* Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
* Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
* Poorly controlled hypertension
* Clinical suspicion of rhabdomyolysis during the screening period
* Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
* Body Mass Index (BMI) \>35 kg/m2 at screening
* Any liver-related clinical event that started (onset) \<8 weeks prior to Baseline (D1).

Where this trial is running

Chandler, Arizona and 130 other locations

+81 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Liver Diseases, AlcoholicGSK4532990Alcohol-related liver diseaseSteatohepatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.