RecruitingPhase 2NCT06613698
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
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)
Sponsor
GlaxoSmithKline
Enrollment
393 participants
Start Date
Sep 27, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria6
- 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 Criteria12
- 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).
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Interventions
DRUGGSK4532990
GSK4532990 will be administered
DRUGPlacebo
Placebo will be administered
Locations(131)
View Full Details on ClinicalTrials.gov
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NCT06613698