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Recruiting Phase 2 NCT06613698

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

Phase 2 – studying effectiveness and dosage
Conditions: Liver Diseases, Alcoholic

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Who can participate
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).
Locations 17
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Australia (1)
GSK Investigational Site
Adelaide , South Australia
US GSK Clinical Trials Call Center
Canada (1)
GSK Investigational Site
Calgary , Alberta
US GSK Clinical Trials Call Center
Denmark (1)
GSK Investigational Site
Esbjerg
US GSK Clinical Trials Call Center
France (1)
GSK Investigational Site
Angers
US GSK Clinical Trials Call Center
Greece (1)
GSK Investigational Site
Athens
US GSK Clinical Trials Call Center
Italy (1)
GSK Investigational Site
Bergamo
US GSK Clinical Trials Call Center
Japan (1)
GSK Investigational Site
Chiba
US GSK Clinical Trials Call Center
Mexico (1)
GSK Investigational Site
DF
US GSK Clinical Trials Call Center
Poland (1)
GSK Investigational Site
Katowice
US GSK Clinical Trials Call Center
South Africa (1)
GSK Investigational Site
Johannesburg
US GSK Clinical Trials Call Center
South Korea (1)
GSK Investigational Site
Ansan
US GSK Clinical Trials Call Center
Spain (1)
GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center
Sweden (1)
GSK Investigational Site
Stockholm
US GSK Clinical Trials Call Center
Turkey (1)
GSK Investigational Site
Kocaeli , İzmit
US GSK Clinical Trials Call Center
United Kingdom (1)
GSK Investigational Site
Bristol
US GSK Clinical Trials Call Center
United States (1)
GSK Investigational Site
Chandler , Arizona
US GSK Clinical Trials Call Center
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
27.09.2024
Completion date
07.03.2028
Registry ID
NCT06613698
Source
anzctr
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