A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease

Last updated: June 13, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Primary Biliary Cholangitis

Treatment

GSK4532990

Placebo

Clinical Study ID

NCT06613698
222291
2024-511596-15
  • Ages 18-65
  • 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.

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: GSK4532990
Phase: 2
Study Start date:
September 27, 2024
Estimated Completion Date:
August 23, 2027

Connect with a study center

  • GSK Investigational Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • GSK Investigational Site

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • GSK Investigational Site

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • GSK Investigational Site

    Melbourne, 3004
    Australia

    Site Not Available

  • GSK Investigational Site

    Parkville Melbourne, 3050
    Australia

    Site Not Available

  • GSK Investigational Site

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • GSK Investigational Site

    New Westminster, British Columbia V3L 3W4
    Canada

    Site Not Available

  • GSK Investigational Site

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • GSK Investigational Site

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • GSK Investigational Site

    Terrebonne, Quebec J6X 4P7
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Esbjerg,
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense C, 5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Angers Cedex 9, 49933
    France

    Site Not Available

  • GSK Investigational Site

    Bobigny cedex, 93000
    France

    Site Not Available

  • GSK Investigational Site

    CrEteil Cedex, 94000
    France

    Site Not Available

  • GSK Investigational Site

    Lille, 59037
    France

    Site Not Available

  • GSK Investigational Site

    Rouen cedex, 76031
    France

    Site Not Available

  • GSK Investigational Site

    Berlin, 10787
    Germany

    Site Not Available

  • GSK Investigational Site

    Kiel, 24105
    Germany

    Site Not Available

  • GSK Investigational Site

    Leipzig, 04103
    Germany

    Site Not Available

  • GSK Investigational Site

    Bergamo, 24127
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Bologna, 40138
    Italy

    Site Not Available

  • GSK Investigational Site

    Messina, 98124
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano, 20162
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Padova, 35131
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, 00128
    Italy

    Site Not Available

  • GSK Investigational Site

    Chiba, 286-8520
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Gunma, 371-8511
    Japan

    Site Not Available

  • GSK Investigational Site

    Kagawa, 760-0017
    Japan

    Site Not Available

  • GSK Investigational Site

    Nara, 634-8522
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 565-0871
    Japan

    Site Not Available

  • GSK Investigational Site

    Saitama, 350-0495
    Japan

    Site Not Available

  • GSK Investigational Site

    Shizuoka, 431-3192
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 180-8610
    Japan

    Site Not Available

  • GSK Investigational Site

    Ansan, 15355
    Korea, Republic of

    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

    Acapulgo, 39670
    Mexico

    Site Not Available

  • GSK Investigational Site

    Ciudad de Mexico, 11510
    Mexico

    Site Not Available

  • GSK Investigational Site

    DF, 14080
    Mexico

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Leon, 24071
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28041
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39011
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46014
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Valladolid, 47003
    Spain

    Site Not Available

  • GSK Investigational Site

    Stockholm, SE-141 86
    Sweden

    Site Not Available

  • GSK Investigational Site

    Uppsala, 753 09
    Sweden

    Site Not Available

  • GSK Investigational Site

    Istanbul, 34010
    Turkey

    Site Not Available

  • GSK Investigational Site

    Izmir, 35100
    Turkey

    Site Not Available

  • GSK Investigational Site

    Glasgow Strathclyde, G51 4TF
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, W2 1NY
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • GSK Investigational Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • GSK Investigational Site

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • GSK Investigational Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • GSK Investigational Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • GSK Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19014
    United States

    Active - Recruiting

  • GSK Investigational Site

    Dallas, Texas 75235
    United States

    Site Not Available

  • GSK Investigational Site

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • GSK Investigational Site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • GSK Investigational Site

    Richmond, Virginia 23249
    United States

    Active - Recruiting

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