The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
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.
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).
Sequential
GSK4532990
DrugGSK4532990 will be administered
Placebo
DrugPlacebo will be administered
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal)
Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device.
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Maximum plasma concentration (Cmax) of GSK4532990
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Plasma half-life (t1/2) of GSK4532990
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