A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease

Description

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

Conditions

Liver Diseases, Alcoholic

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Study Overview

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Study Details

Study overview

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

A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease

Condition
Liver Diseases, Alcoholic
Intervention / Treatment

-

Contacts and Locations

Chandler

GSK Investigational Site, Chandler, Arizona, United States, 85224

Los Angeles

GSK Investigational Site, Los Angeles, California, United States, 90033

Brandon

GSK Investigational Site, Brandon, Florida, United States, 33511

Miami Lakes

GSK Investigational Site, Miami Lakes, Florida, United States, 33016

Indianapolis

GSK Investigational Site, Indianapolis, Indiana, United States, 46202

Marrero

GSK Investigational Site, Marrero, Louisiana, United States, 70072

Detroit

GSK Investigational Site, Detroit, Michigan, United States, 48202

Philadelphia

GSK Investigational Site, Philadelphia, Pennsylvania, United States, 19014

McAllen

GSK Investigational Site, McAllen, Texas, United States, 78503

San Antonio

GSK Investigational Site, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 or ongoing 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 liver transplant or current listing for liver transplant during the screening period.
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

Study Record Dates

2027-08-23