Primary objectives~This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives:~Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology.~Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives~Key secondary objectives of Part 1:~To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis~To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH~Other secondary objectives of both Part 1 and Part 2:~To assess the effect of lanifibranor on other key histological features of NASH (only for DBPC period)~To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period)~To assess the effect of lanifibranor on liver tests~To assess the effect of lanifibranor on glycaemic parameters~To assess the effect of lanifibranor on lipid parameters~To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography.~To assess the effect of lanifibranor on health-related quality of life~To assess the safety of lanifibranor~To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3