RECRUITINGPhase 2INTERVENTIONAL
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)
About This Trial
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Who May Be Eligible (Plain English)
Who May Qualify:
- Capable of giving signed willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
DRUG
GSK4532990
GSK4532990 will be administered
DRUG
Placebo
Placebo will be administered
Locations (20)
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Davis, California, United States
GSK Investigational Site
Los Angeles, California, 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
Atlanta, Georgia, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Marrero, Louisiana, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Arlington, Texas, United States
GSK Investigational Site
Austin, Texas, United States