Zydus Announces Completion of Enrolment in EVIDENCES IV Phase 2 Clinical Trial of Saroglitazar Magnesium in NASH

AHMEDABAD: Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has completed enrolment of 104 patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including Non-Alcoholic SteatoHepatitis (NASH) across 20 clinical sites in the United States of America.

The trial will evaluate the percentage change from baseline in serum ALT levels in patients treated with Saroglitazar Magnesium as compared to placebo as the primary endpoint. The change in liver fat content as measured by magnetic resonance imaging will also be compared, along with several other secondary endpoints.

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

Speaking on the development, Mr Pankaj R. Patel, Chairman, Zydus group said, "This is a major milestone in our innovation journey and we hope to report the top-line results of this trial by the end of the year.

In keeping with our mission of creating healthier, happier communities, we are committed towards developing this drug for millions of patients suffering from NASH, an unmet healthcare need."

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