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Zydus Lifesciences commences Phase IV trial of EVIDENCES-XI

9 Jun 2023 , 01:28 PM

Zydus Lifesciences Ltd. revealed the start of Phase IV of the ‘EVIDENCES- XI’ Real World Data Registry trial for Saroglitazar Magnesium in NAFLD patients with comorbidities.

The EVIDENCES- XI Phase IV trial is expected to enroll approximately 1500 male and female NAFLD patients with comorbidities (obesity, type 2 diabetes mellitus, dyslipidemia, or metabolic syndrome- 200 patients each).

The study will continue for approximately 56 weeks. The primary endpoint is the change in liver stiffness measured by transient elastography between baseline and Week 52.

In India, Saroglitazar Mg was studied in two well-controlled Phase 3 clinical trials in patients with NAFLD and NASH. In the first Phase 3 trial, Saroglitazar Mg demonstrated a significant difference of 28% versus placebo in the primary end-point NAFLD Activity Score (NAS) by at least 2 points.

With two separate EPICS-I and EPICS-II series of trials conducted in the United States and Mexico, Saroglitazar Mg was studied in patients with Primary Biliary Cholangitis (PBC), a rare liver disease.

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