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
NCT ID: NCT06613698
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
393 participants
INTERVENTIONAL
2024-09-27
2027-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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GSK4532990 Dose 1
GSK4532990
GSK4532990 will be administered
GSK4532990 Dose 2
GSK4532990
GSK4532990 will be administered
GSK4532990 Dose 3
GSK4532990
GSK4532990 will be administered
GSK4532990 Dose 4
GSK4532990
GSK4532990 will be administered
Placebo
Placebo
Placebo will be administered
Interventions
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GSK4532990
GSK4532990 will be administered
Placebo
Placebo will be administered
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Brandon, Florida, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Marrero, Louisiana, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Terrebonne, Quebec, Canada
GSK Investigational Site
Bergamo, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Chiba, , Japan
GSK Investigational Site
Kagawa, , Japan
GSK Investigational Site
Ansan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon Gyeonggi-do, , South Korea
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
León, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Glasgow Strathclyde, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-511596-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
222291
Identifier Type: -
Identifier Source: org_study_id
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