This Phase 2b study is a randomized, double-blind, parallel-arm, placebo-controlled trial to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg compared with placebo in subjects with NASH. Subjects will be randomized 1:1:1 to receive Saroglitazar Magnesium 4 mg, Saroglitazar Magnesium 2 mg, or placebo via IVRS/IWRS. Total duration of the study will be up to 89 weeks including two screening visits (12 weeks), randomization and double-blind treatment phase (76 weeks), and a safety follow-up of 1 week after the last administration of study drug. Subjects will be evaluated at the study site for 14 scheduled visits. During the course of the study subjects will have 2 liver biopsies and 6 transient elastography/FibroScan performed to monitor liver fibrosis.

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with NASH/MASH cirrhosis and fibrosis stage 4.

Primary objective is to evaluate the effect of EFX compared to placebo on achieving
NASH/MASH resolution AND fibrosis regression at Week 52 (in
Cohort 1 only) and to evaluate the effect of EFX compared to placebo on all-cause
mortality and liver-related clinical outcomes as measured by the
time to first occurrence of any of the predefined, adjudicated events
in subjects with NASH/MASH and fibrosis.