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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)

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease (STARLIGHT)

Okamasa Arisa

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Okamasa Arisa

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Recruiting

Oct. 15, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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.
- Participant has advanced chronic liver disease

- 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 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).

Both

Alchol-related Liver Desease(ALD)

-GSK4532990 Dose1
-GSK4532990 Dose2
-GSK4532990 Dose3
-GSK4532990 Dose4
-Placebo

- Number of participants with adverse events (AEs) and serious adverse events (SAEs) up to 8 weeks
- Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests up to 8 weeks
- Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan(Registered Trademark) at Week 52
- Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52

- Maximum plasma concentration (Cmax), Area Under the Curve from Time 0 to t [AUC (0-t)] , Plasma half-life (t1/2), Apparent clearance (CL/F), Time to maximum concentration (tmax), Apparent terminal phase volume of distribution (Vz/F) of GSK4532990 up to Day4, and Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990 up to 24 hours
- Change from baseline in serum AST at Week 52
- Change from baseline in Enhanced Liver Fibrosis (ELF_trademark) score at Week 52
-Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
- Maximum observed plasma concentration (Cmax) of GSK4532990

+81-87-831-7101

Sept. 20, 2024

No

United States/United Kingdom/Sweden/Turkey/Australia/Canada/Mexico/Denmark/Spain/Italy/Germany/France/South Korea/Argentina/Greece/Poland/South Africa/Israel/Thialand