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GSK4532990 for Alcohol-related Liver Disease (STARLIGHT Trial)
Verified 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
Have type 2 diabetes
Be older than 18 years old
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
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), and at week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), and at week 28
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
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,381,111 Total Patients Enrolled
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