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Clinical Trials in Denmark / NCT06613698
Recruiting Phase 2

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

NCT06613698 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2024-09-27
Last updated
2026-08-03

Condition(s) studied

Liver Diseases, Alcoholic

Investigational drug(s) / intervention(s)

GSK4532990 →Placebo

GSK4532990: GSK4532990 will be administered

Placebo: Placebo will be administered

Study summary

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)

Trial sites (140)

FacilityCityRegionStatus
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.

More GlaxoSmithKline trials in Denmark

Other trials for the same condition

Official registry record

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.

View NCT06613698 on ClinicalTrials.gov ↗ ← All trials in Denmark