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GSK4532990 for Alcohol-related Liver Disease (STARLIGHT Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), and at week 28

Summary

"This trial aims to see if GSK4532990 is safe and effective for people with liver disease caused by alcohol."

Who is the study for?
This trial is for adults aged 18 to 65 with alcohol-related liver disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.
What is being tested?
The study aims to test the safety and effectiveness of a new medication called GSK4532990 compared to a placebo in treating alcohol-related liver disease.
What are the potential side effects?
Potential side effects of GSK4532990 are not detailed here, but common drug-related side effects could include gastrointestinal issues, headaches, fatigue, and allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver is failing according to NACSELD standards.
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My blood tests for liver and kidney function are within normal ranges.
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I have had a TIPSS procedure.
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I have had a liver transplant or am on the waiting list for one.
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I have a blood clot in the vein to my liver.
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I haven't had a heart attack, unstable chest pain, heart failure, or stroke in the last 6 months.
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My blood pressure is not well controlled.
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I might have muscle breakdown.
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I might have had a bleeding episode due to high blood pressure in the liver veins or low blood clotting protein.
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I do not have any cancer except for basal cell carcinoma or uterine carcinoma-in-situ.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), and at week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), and at week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 28 (kiloPascal)
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 28
Secondary study objectives
Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 28

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK4532990 Dose 4Experimental Treatment1 Intervention
Group II: GSK4532990 Dose 3Experimental Treatment1 Intervention
Group III: GSK4532990 Dose 2Experimental Treatment1 Intervention
Group IV: GSK4532990 Dose 1Experimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,799 Previous Clinical Trials
8,377,223 Total Patients Enrolled
~262 spots leftby Dec 2026
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