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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

RecruitingPhase 2

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)

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
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).

About the study

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

What is being tested

Sponsor: GlaxoSmithKline · Participants: 393 · Started: Sep 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06613698

Locations in the U.S.

ArizonaGSK Investigational Site, Chandler
GSK Investigational Site, Phoenix
GSK Investigational Site, Tucson
GSK Investigational Site, Tucson
CaliforniaGSK Investigational Site, Coronado
GSK Investigational Site, Lancaster
GSK Investigational Site, Los Angeles
GSK Investigational Site, Los Angeles
GSK Investigational Site, Pasadena
GSK Investigational Site, Sacramento
FloridaGSK Investigational Site, Brandon
GSK Investigational Site, Miami
GSK Investigational Site, Miami Lakes
GeorgiaGSK Investigational Site, Atlanta
IndianaGSK Investigational Site, Indianapolis
KansasGSK Investigational Site, Topeka
LouisianaGSK Investigational Site, Marrero
MichiganGSK Investigational Site, Detroit
NevadaGSK Investigational Site, Las Vegas
New YorkGSK Investigational Site, New York
North CarolinaGSK Investigational Site, Chapel Hill
OhioGSK Investigational Site, Cleveland
PennsylvaniaGSK Investigational Site, Philadelphia
TennesseeGSK Investigational Site, Hermitage
TexasGSK Investigational Site, Arlington
GSK Investigational Site, Austin
GSK Investigational Site, Dallas
GSK Investigational Site, Dallas
GSK Investigational Site, Fort Worth
GSK Investigational Site, Georgetown
GSK Investigational Site, San Antonio
VirginiaGSK Investigational Site, Richmond
GSK Investigational Site, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.