NEW DELHI, June 9: Zydus Lifesciences on Friday said it has commenced Phase IV real world data registry trial to ascertain the benefits of Saroglitazar Magnesium in non-alcoholic fatty liver disease (NAFLD) patients with comorbidities.
The “Phase IV EVIDENCES- XI” trial will enrol around 1,500 male and female NAFLD patients with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome- 200 patients each), the drug maker said in a regulatory filing.
The study duration is around 56 weeks, it added.
The primary endpoint is to measure the change in liver stiffness from baseline to 52nd week, it said.
Rohit Loomba, MD, Professor of Medicine, Division Chief of Gastroenterology at University of California, San Diego School of Medicine and Director of Hepatology at UC San Diego Health will lead the steering committee of the trial, Zydus said.
“It will help generate novel real world data in NAFLD/NASH patients that is especially lacking in Asian populations. Real world data is crucial to formulate clinical guidelines, to further support its use in clinical practice,” Loomba said.
Zydus Lifesciences Chairman Pankaj R Patel said the company has now studied Saroglitazar Mg in over 10 different trials.
“We hope that this (latest trial) will be a big leap forward in managing and treating the unmet healthcare needs of NAFLD and nonalcoholic steatohepatitis, (NASH),” he added.
The second Phase III study of Saroglitazar Mg in NAFLD patients demonstrated that treatment with Saroglitazar Mg had a beneficial effect on primary end-point of change in liver fat content.
(PTI)
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