Prespecified study endpoints
sleep disturbance, itch, fibrosis, NASH, steatohepatitis
SECONDARY, FIBROSIS, STEATOHEPATITIS
The primary endpoints included occurrence of SAEs, AEs resulting in treatment discontinuation and/or dose reductions, AEs of special interest up to end-of-study, changes in ALT and AST from baseline to week 12, and relative change in % HFF from baseline to week 12. Secondary endpoints included changes from baseline to week 12 in body weight, FGF19 and C4 levels, GGT and fasting lipid profile. Occurrence of potential itch was also assessed using VAS as a patient-reported outcome. VAS for sleep disturbance due to nocturnal itch was assessed as an exploratory endpoint. Additional secondary endpoints for Part C included the proportion of patients achieving ≥1 stage improvement in fibrosis (NASH CRN) without worsening of steatohepatitis or resolution of steatohepatitis without worsening of fibrosis at week 48 compared with baseline, changes in ALT and AST levels from baseline to week 48 and relative change in % HFF from baseline to week 48. Exploratory endpoints at week 48 included changes in total NAS and individual components.