Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

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)

Keywords

Liver Diseases, Alcoholic, GSK4532990, Alcohol-related liver disease, Steatohepatitis, Alcoholic Liver Diseases, Fatty Liver

Eligibility

You can join if…

Open to people ages 18-70

  • 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 CAN'T join 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).

Locations

  • GSK Investigational Site accepting new patients
    Sacramento California 95817 United States
  • GSK Investigational Site accepting new patients
    Lancaster California 93534 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlaxoSmithKline
Links
Sign up for this study
ID
NCT06613698
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 393 study participants
Last Updated