NCT06613698 · GlaxoSmithKline
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)
What this study is about
The goal of this study is to assess the safety and effectiveness of GSK4532990 in participants with alcohol-related liver disease.
View original scientific description
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Interventions
DRUG
GSK4532990
GSK4532990 will be administered
DRUG
Placebo
Placebo will be administered
Primary outcome measures
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
Time frame: Up to 8 weeks
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal)
Time frame: Baseline (Day 1) and up to Week 52
Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device.
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52
Time frame: Baseline (Day 1) and up to Week 52
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chandler, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Davis, California
- Los Angeles, California
- Brandon, Florida
- Miami Lakes, Florida
- Atlanta, Georgia
- Indianapolis, Indiana
- Topeka, Kansas
- Marrero, Louisiana
- Detroit, Michigan
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations