Zydus Cadila update on clinical trial of Saroglitazar Magnesium in NAFLD and NASH

Zydus Cadila announced that Saroglitazar Magnesium has achieved the primary end-points in the EVIDENCES IV trial in patients with NAFLD and NASH.

The EVIDENCES IV NASH trial was a randomized, double-blind, placebo-controlled study that enrolled 106 patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including Non-Alcoholic Steatohepatitis (NASH) across 20 clinical sites in the United States of America. Patients were randomly assigned in a ratio of 1:1:1:l to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks.

A statistically significant reduction in hepatic fat content from baseline was observed in patients treated with Saroglitazar Magnesium as compared to placebo following 16 weeks of treatment as measured by MRI-PDFF. The secondary endpoints of the trial also included measurements of other Liver enzymes, Insulin resistance, Liver fibrosis, BMI, Waist circumference, MRI-derived measures of total liver fat index, Lipid and lipoprotein levels, and pharmacokinetic parameters.

This study is one of several EVIDENCES trials conducted to assess the effect of Saroglitazar Magnesium in various populations with NAFLD, including patients with NASH.

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