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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

NCT06613698

RecruitingPhase 2

Sponsor: GlaxoSmithKline

Conditions: Liver Diseases, Alcoholic

Interventions: GSK4532990, Placebo

Countries: United States, Argentina, Australia, Canada, Denmark, France, Germany, Greece

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).

Locations (140)

Chandler, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Coronado, California, United States
Lancaster, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Sacramento, California, United States
Brandon, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Topeka, Kansas, United States
Marrero, Louisiana, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Hermitage, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Georgetown, Texas, United States
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