Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
Status:
Completed
Trial end date:
2020-12-15
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a
diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks
and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week
Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a
ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo
once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is
percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium
groups as compared to the placebo group.