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The phase IV Evidences- XI trial will enrol approximately 1500 male and female NAFLD patients with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome- 200 patients each).
The study duration is approximately 56 weeks. The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52.
Pankaj R. Patel, chairman of Zydus Lifesciences said, “NAFLD and NASH are serious life-threatening conditions and we have now studied Saroglitazar mg in over 10 different trials which have been completed and the ongoing EVIDENCES I to X series of clinical trials in patients with NAFLD and NASH across clinical sites in India, Mexico, USA and Europe. We hope that this will be a big leap forward in managing and treating the unmet healthcare needs of NAFLD and NASH.”
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit (from continuing operations) tumbled 27.55% to Rs 298.8 crore despite of 31.66% jump in total revenue from operations to Rs 5,010.6 crore in Q4 FY23 over Q4 FY22.
The scrip rose 0.50% to currently trade at Rs 515.60 on the BSE.
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