RECRUITING

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

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Conditions

Liver Diseases, AlcoholicGSK4532990Alcohol-related liver diseaseSteatohepatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2024-09-27
Study Completion:2027-08-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06613698

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Capable of giving signed informed consent prior to the performance of any study-specific procedures.
  2. * Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
  3. * In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.
  4. * A female participant is eligible to participate after meeting additional pre-defined criteria.
  5. * Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
  1. * Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
  2. * 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.
  3. * Current or ongoing malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
  4. * Prior liver transplant or current listing for liver transplant during the screening period.
  5. * Chronic or acute, including partial, known portal vein thrombosis.
  6. * Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
  7. * Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
  8. * Poorly controlled hypertension
  9. * Clinical suspicion of rhabdomyolysis during the screening period
  10. * Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
  11. * Body Mass Index (BMI) \>35 kg/m2 at screening

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site
Chandler, Arizona, 85224
United States
GSK Investigational Site
Los Angeles, California, 90033
United States
GSK Investigational Site
Brandon, Florida, 33511
United States
GSK Investigational Site
Miami Lakes, Florida, 33016
United States
GSK Investigational Site
Indianapolis, Indiana, 46202
United States
GSK Investigational Site
Marrero, Louisiana, 70072
United States
GSK Investigational Site
Detroit, Michigan, 48202
United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19014
United States
GSK Investigational Site
McAllen, Texas, 78503
United States
GSK Investigational Site
San Antonio, Texas, 78215
United States
GSK Investigational Site
Richmond, Virginia, 23249
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-27
Study Completion Date2027-08-23

Study Record Updates

Study Start Date2024-09-27
Study Completion Date2027-08-23

Terms related to this study

Keywords Provided by Researchers

  • GSK4532990
  • Alcohol-related liver disease
  • Steatohepatitis

Additional Relevant MeSH Terms

  • Liver Diseases, Alcoholic