A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease

Last updated: July 31, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Primary Biliary Cholangitis

Treatment

Placebo

GSK4532990

Clinical Study ID

NCT06613698
222291
2024-511596-15
  • Ages 18-70
  • All Genders

Study Summary

The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of giving signed informed consent prior to the performance of anystudy-specific procedures.

  • Able and willing to comply with all study assessments and adhere to the protocolschedule of activities.

  • In the opinion of the investigator, there is a history of alcohol consumptioncompatible with either ALD or Met ALD.

  • A female participant is eligible to participate after meeting additional pre-definedcriteria.

  • Participants must meet predefined stable use requirements of concomitant medicationsbased on study criteria.

  • Participant has advanced chronic liver disease

Exclusion

Exclusion Criteria:

  • Meeting any definition of organ system failure as defined by the North AmericanConsortium 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) atscreening. Participants under evaluation for possible malignancy at screening arenot eligible.

  • Prior organ transplant or current listing or active consideration for organtransplant 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 toscreening.

  • Poorly controlled hypertension

  • Clinical suspicion of rhabdomyolysis during the screening period

  • Clinical suspicion of a bleeding episode during the screening period related toportal 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).

Study Design

Total Participants: 393
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 27, 2024
Estimated Completion Date:
March 07, 2028

Connect with a study center

  • GSK Investigational Site

    Buenos Aires,
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires 3435910, 1425
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, 1118
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1426
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, S2002
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Parkville Melbourne, Victoria 2145234 3050
    Australia

    Active - Recruiting

  • GSK Investigational Site

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Terrebonne, J6X 4P7
    Canada

    Site Not Available

  • GSK Investigational Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Berlin 2950159, 10787
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Athens, 11527
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Milan, 20162
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milan 6951411, 20162
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milano, 20122
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Roma, 00168
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Roma 8957247, 00168
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Kagawa, 760-0017
    Japan

    Site Not Available

  • GSK Investigational Site

    Kagawa 1860837, 761-0793
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Osaka, 564-0013
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Osaka 1853909, 564-0013
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 07061
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 138-736
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Seoul 1835848, 07061
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08003
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Barcelona 3128760, 08003
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28006
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid 3117735, 28006
    Spain

    Active - Recruiting

  • GSK Investigational Site

    London, W2 1NY
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    London 2643743, W2 1NY
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • GSK Investigational Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • GSK Investigational Site

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dallas, Texas 75203
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dallas 4684888, Texas 4736286 75203
    United States

    Active - Recruiting

  • GSK Investigational Site

    Richmond, Virginia 23249
    United States

    Active - Recruiting

  • GSK Investigational Site

    Richmond 4781708, Virginia 6254928 23249
    United States

    Active - Recruiting

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