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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Liver Diseases, Alcoholic

In brief

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

Key facts

Study ID

NCT06613698

Run by

GlaxoSmithKline

People needed

393

Starts

2024-09-27

Expected to finish

2028-03-07

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States (enrolling)
• GSK Investigational Site — Tucson, Arizona, United States (enrolling)
• GSK Investigational Site — Tucson, Arizona, United States (enrolling)
• GSK Investigational Site — Coronado, California, United States (enrolling)
• GSK Investigational Site — Lancaster, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — Los Angeles, California, United States (enrolling)
• GSK Investigational Site — Pasadena, California, United States (enrolling)
• GSK Investigational Site — Sacramento, California, United States (enrolling)
• GSK Investigational Site — Brandon, Florida, United States (enrolling)
• GSK Investigational Site — Miami, Florida, United States (enrolling)
• GSK Investigational Site — Miami Lakes, Florida, United States (enrolling)
• GSK Investigational Site — Atlanta, Georgia, United States (enrolling)
• GSK Investigational Site — Indianapolis, Indiana, United States (enrolling)
• GSK Investigational Site — Topeka, Kansas, United States (enrolling)
• GSK Investigational Site — Marrero, Louisiana, United States (enrolling)
• GSK Investigational Site — Detroit, Michigan, United States (enrolling)
• GSK Investigational Site — Las Vegas, Nevada, United States (enrolling)
• GSK Investigational Site — New York, New York, United States (enrolling)
• GSK Investigational Site — Chapel Hill, North Carolina, United States (enrolling)
• GSK Investigational Site — Cleveland, Ohio, United States (enrolling)
• GSK Investigational Site — Philadelphia, Pennsylvania, United States (enrolling)
• GSK Investigational Site — Hermitage, Tennessee, United States (enrolling)
• GSK Investigational Site — Arlington, Texas, United States (enrolling)
• GSK Investigational Site — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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