 "Zydus Lifesciences")
Zydus Lifesciences Ltd, on Friday, announced the commencement of Phase-IV real-world data registry trial ‘Evidences- XI’ for Saroglitazar Magnesium in non-alcoholic fatty liver disease (NAFLD) patients with comorbidities.
In a regulatory filing, the company said, “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).”
Pankaj R Patel, chairman, Zydus Lifesciences Ltd 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.”
I’d like to thank all the patients, investigators, and study sites that are now participating in our Phase 4 Evidences-XI Real World Evidence trial. We hope that this will be a big leap forward in managing and treating the unmet healthcare needs of NAFLD and NASH,” he added.
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, the company said in a statement.
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Shares of Zydus Lifesciences Ltd, on Friday, fell over 1 per cent at Rs 507.60 on the BSE.
Dr. Rohit Loomba, MD, Professor of Medicine, Division Chief of Gastroenterology at the University of California, San Diego School of Medicine, and Director of Hepatology at UC San Diego Health will lead the steering committee of this Phase IV Evidences- RWD Study.
“This Phase 4 Evidences-study is a landmark study establishing one of the largest prospective registry of patients with non-alcoholic steatohepatitis (NASH) in the world. It will help generate novel real-world data (RWD) in NAFLD/NASH patients that is especially lacking in Asian populations,” said Dr. Rohit Loomba.
“Real world data is crucial to formulate clinical guidelines, to further support its use in clinical practice and this will add to our existing knowledge of Saroglitazar Mg and its role in the management of NAFLD/ NASH,” he added.
Saroglitazar Mg has been studied in two well-controlled Phase 3 clinical trials in patients with NAFLD and NASH in India.
