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 (STARLIGHT)

GlaxoSmithKline (GSK)

Status and phase: Not yet enrolling; Phase 2

Conditions: Liver Diseases, Alcoholic

Treatments: Drug: Placebo; Drug: GSK4532990

Study type: Interventional

Funder types: Industry

Identifiers

NCT06613698

222291

2024-511596-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 393 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

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 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.
• Prior liver transplant or current listing for liver transplant during the screening period.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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393 participants in 5 patient groups, including a placebo group

GSK4532990 Dose 1

Experimental group

Treatment:

Drug: GSK4532990

GSK4532990 Dose 2

Experimental group

Treatment:

Drug: GSK4532990

GSK4532990 Dose 3

Experimental group

Treatment:

Drug: GSK4532990

GSK4532990 Dose 4

Experimental group

Treatment:

Drug: GSK4532990

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo