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)

Alcoholic, Liver Diseases

Safety Lead-in Incidence of AEs and of SAEs., Safety Lead-in Incidence of potentially clinically relevant changes from baseline in ECG, vital signs, and clinical laboratory tests., Main Study Period COMP cohort • Change from baseline in LSM using FibroScan® at Week 28, considering death, liver-related hospitalization, liver transplantation and HCC to be poor outcomes DECOMP cohort • Change from baseline in MELD score at Week 28, considering death, liver-related hospitalization, liver transplantation and HCC to be poor outcomes

Safety Lead-in GSK4532990 plasma Cmax, AUC(0-t), AUC(0-24), t1/2, CL/F, tmax, and Vz/F following a single subcutaneous dose of GSK4532990., Main Study Period COMP cohort • Change from baseline in LSM using FibroScan® at Weeks 4, 8, 12, 16, 20, and 24, considering death, liver-related hospitalization, liver transplantation and HCC to be poor outcomes DECOMP cohort • Change from baseline in MELD score at Weeks 4, 8, 12, 16, 20, and 24, considering death, liver-related hospitalization, liver transplantation and HCC to be poor outcomes, Main Study Period COMP cohort, INTER cohort, DECOMP cohort and POOLED In a subset of participants with intensive PK sampling, plasma exposure parameters of GSK4532990 including: • Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) • Maximum observed concentration (Cmax)

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