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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGlaxoSmithKline

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • GSK4532990
  • Placebo

Treatment groups

393 Participants
are divided into 5 treatment groups

Sponsors and collaborators