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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 2Ages 18 Years - 70 YearsAllGlaxoSmithKline
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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).
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What it tests

  • GSK4532990
  • Placebo
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Where

140 sites
GSK Investigational Site
Chandler, United States
GSK Investigational Site
Phoenix, United States
GSK Investigational Site
Tucson, United States
GSK Investigational Site
Tucson, United States
GSK Investigational Site
Coronado, United States
GSK Investigational Site
Lancaster, United States
GSK Investigational Site
Los Angeles, United States
GSK Investigational Site
Los Angeles, United States

โ€ฆand 132 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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