Last updated: 06/13/2025 06:00:42
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 diseaseSTARLIGHT
GSK study ID
222291
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults with Alcohol-related Liver Disease (ALD)
Trial description: The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
Timeframe: Up to 8 weeks
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 28 (kiloPascal)
Timeframe: Baseline (Day 1) and up to Week 28
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 28
Timeframe: Baseline (Day 1) and up to Week 28
Secondary outcomes:
Maximum plasma concentration (Cmax) of GSK4532990
Timeframe: Up to Day 4
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Timeframe: Up to Day 4
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Timeframe: Up to 24 hours
Plasma half-life (t1/2) of GSK4532990
Timeframe: Up to Day 4
Apparent clearance (CL/F) of GSK4532990
Timeframe: Up to Day 4
Time to maximum concentration (tmax) of GSK4532990
Timeframe: Up to Day 4
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Timeframe: Up to Day 4
Change from baseline in serum AST at Week 28
Timeframe: Baseline (Day 1), and at Week28
Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 28
Timeframe: Baseline (Day 1), and at Week 28
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Timeframe: Up to Day 3
Maximum observed plasma concentration (Cmax) of GSK4532990
Timeframe: Up to Day 3
Interventions:
Enrollment:
393
Primary completion date:
2026-08-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Liver Diseases, Alcoholic
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2024 to August 2027
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Capable of giving signed informed consent prior to the performance of any study-specific procedures.
Exclusion criteria:
- 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).
- 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
- Any liver-related clinical event that started (onset) <8 weeks prior to Baseline (D1).
Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
Trial location(s)
Showing 1 - 6 of 26 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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