RecruitingLiver Diseases, Alcoholic

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: GlaxoSmithKline

✓ 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

✕ 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