AHMEDABAD: Homegrown pharma major, Zydus Lifesciences Limited on Friday announced it has commenced the Phase-IV Real World Data registry trial Evidence-XI for Saroglitazar Magnesium (Mg) in Non-Alcoholic Fatty Liver Disease (NAFLD) patients with comorbidities.
The Phase-IV, Evidence-XI trial is set to enrol some 1,500 male and female NAFLD patients with comorbidities including type-II diabetes mellitus, dyslipidemia, or obesity. The study duration will pan over some 56 weeks.
The primary endpoint is to measure the change in liver stiffness measurement performed at the end of 52 weeks, the company said in a statement.
Saroglitazar Mg has been studied in two well-controlled Phase-II clinical trials in patients with NAFLD and Non-Alcoholic Steatohepatitis (NASH) in India by far.
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 the Phase-IV Evidences Real World Data Study.
“This will be a landmark study that will help establish one of the largest prospective registries of patients with NASH. It will help generate novel Real World Data (RWD) in NAFLD/NASH patients, especially lacking in Asian population. 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 said.
Pankaj R. Patel, Chairman, Zydus Lifesciences, said, “NAFLD and NASH are serious life-threatening conditions and we have now studied Saroglitazar Mg in over ten 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,” he added.
The USFDA has granted Fast Track status and Orphan Drug Designation for Saroglitazar Mg in PBC. Saroglitazar Mg has also received Orphan Drug Designation in Europe for the treatment of PBC. Once approved, the Orphan drug designation will lead to 10 years of market exclusivity in Europe.
Zydus Lifesciences shares traded at Rs 507.15 on BSE as the markets closed on Friday, down 1.1% against its previous close.
The Phase-IV, Evidence-XI trial is set to enrol some 1,500 male and female NAFLD patients with comorbidities including type-II diabetes mellitus, dyslipidemia, or obesity. The study duration will pan over some 56 weeks.
The primary endpoint is to measure the change in liver stiffness measurement performed at the end of 52 weeks, the company said in a statement.
Saroglitazar Mg has been studied in two well-controlled Phase-II clinical trials in patients with NAFLD and Non-Alcoholic Steatohepatitis (NASH) in India by far.
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 the Phase-IV Evidences Real World Data Study.
“This will be a landmark study that will help establish one of the largest prospective registries of patients with NASH. It will help generate novel Real World Data (RWD) in NAFLD/NASH patients, especially lacking in Asian population. 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 said.
Pankaj R. Patel, Chairman, Zydus Lifesciences, said, “NAFLD and NASH are serious life-threatening conditions and we have now studied Saroglitazar Mg in over ten 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,” he added.
The USFDA has granted Fast Track status and Orphan Drug Designation for Saroglitazar Mg in PBC. Saroglitazar Mg has also received Orphan Drug Designation in Europe for the treatment of PBC. Once approved, the Orphan drug designation will lead to 10 years of market exclusivity in Europe.
Zydus Lifesciences shares traded at Rs 507.15 on BSE as the markets closed on Friday, down 1.1% against its previous close.