The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
393
GSK4532990 will be administered
Placebo will be administered
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 28 (kiloPascal)
Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device.
Time frame: Baseline (Day 1) and up to Week 28
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 28
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.
Time frame: Baseline (Day 1) and up to Week 28
Maximum plasma concentration (Cmax) of GSK4532990
Time frame: Up to Day 4
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Time frame: Up to Day 4
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Time frame: Up to 24 hours
Plasma half-life (t1/2) of GSK4532990
Time frame: Up to Day 4
Apparent clearance (CL/F) of GSK4532990
Time frame: Up to Day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Chandler, Arizona, United States
RECRUITINGGSK Investigational Site
Phoenix, Arizona, United States
RECRUITINGGSK Investigational Site
Tucson, Arizona, United States
RECRUITINGGSK Investigational Site
Davis, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Brandon, Florida, United States
RECRUITINGGSK Investigational Site
Miami Lakes, Florida, United States
RECRUITINGGSK Investigational Site
Atlanta, Georgia, United States
RECRUITINGGSK Investigational Site
Indianapolis, Indiana, United States
RECRUITING...and 113 more locations
Time to maximum concentration (tmax) of GSK4532990
Time frame: Up to Day 4
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Time frame: Up to Day 4
Change from baseline in serum AST at Week 28
Time frame: Baseline (Day 1), and at Week28
Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 28
The ELF™ score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers, including tissue inhibitor of metalloproteinases-1 (TIMP-1), type III procollagen (PIIINP), and hyaluronic acid (HA). The ELF™ score is used as a prognostic marker for disease progression. ELF™ score will range between 4.5 to 14.7. A higher ELF™ score will predict worse prognosis
Time frame: 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
Time frame: Up to Day 3
Maximum observed plasma concentration (Cmax) of GSK4532990
Time frame: Up to Day 3