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)

JRCT ID: jRCT2061240059

Registered date:02/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alchol-related Liver Desease(ALD)
• Date of first enrollment: 15/10/2024
• Target sample size: 393
• Countries of recruitment: United States,Japan,United Kingdom,Japan,Sweden,Japan,Turkey,Japan,Australia,Japan,Canada,Japan,Mexico,Japan,Denmark,Japan,Spain,Japan,Italy,Japan,Germany,Japan,France,Japan,South Korea,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

-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 28
-Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 28

Secondary Outcome

-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 28
-Change from baseline in Enhanced Liver Fibrosis (ELF_trademark) score at Week 28
-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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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 (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
-Current or ongoing 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 liver transplant or current listing for liver transplant during the screening period.
-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

Related Information

• Primary Sponsor: Okamasa Arisa
• Secondary ID(s): NCT06613698