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
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Number of participants with adverse events (AEs) and serious adverse events (SAEs) — Up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests — Up to 8 weeks
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal) — Baseline (Day 1) and up to Week 52 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 — Baseline (Day 1) and up to 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.
Trial sites (140)
Facility
City
Region
Status
GSK Investigational Site
Chandler
Arizona
Recruiting
GSK Investigational Site
Phoenix
Arizona
Recruiting
GSK Investigational Site
Tucson
Arizona
Recruiting
GSK Investigational Site
Tucson
Arizona
Recruiting
GSK Investigational Site
Coronado
California
Recruiting
GSK Investigational Site
Lancaster
California
Recruiting
GSK Investigational Site
Los Angeles
California
Recruiting
GSK Investigational Site
Los Angeles
California
Recruiting
GSK Investigational Site
Pasadena
California
Recruiting
GSK Investigational Site
Sacramento
California
Recruiting
GSK Investigational Site
Brandon
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami Lakes
Florida
Recruiting
GSK Investigational Site
Atlanta
Georgia
Recruiting
GSK Investigational Site
Indianapolis
Indiana
Recruiting
GSK Investigational Site
Topeka
Kansas
Recruiting
GSK Investigational Site
Marrero
Louisiana
Recruiting
GSK Investigational Site
Detroit
Michigan
Recruiting
GSK Investigational Site
Las Vegas
Nevada
Recruiting
GSK Investigational Site
New York
New York
Recruiting
GSK Investigational Site
Chapel Hill
North Carolina
Recruiting
GSK Investigational Site
Cleveland
Ohio
Recruiting
GSK Investigational Site
Philadelphia
Pennsylvania
Recruiting
GSK Investigational Site
Hermitage
Tennessee
Recruiting
GSK Investigational Site
Arlington
Texas
Recruiting
GSK Investigational Site
Austin
Texas
Recruiting
GSK Investigational Site
Dallas
Texas
Recruiting
GSK Investigational Site
Dallas
Texas
Recruiting
GSK Investigational Site
Fort Worth
Texas
Recruiting
GSK Investigational Site
Georgetown
Texas
Recruiting
GSK Investigational Site
McAllen
Texas
Completed
GSK Investigational Site
San Antonio
Texas
Recruiting
GSK Investigational Site
Richmond
Virginia
Recruiting
GSK Investigational Site
Richmond
Virginia
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire
Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire
Argentina
Recruiting
+ 100 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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