About this trial
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- GSK4532990
- Placebo