Zydus Lifesciences Ltd. on Friday announced the commencement of the phase IV trial for Saroglitazar Magnesium among patients having non-alcoholic fatty liver disease (NFLD) and comorbidities.
Saroglitazar Magnesium is used in the treatment of major conditions related to type 2 diabetes and non-alcoholic fatty liver disease.
Zydus, along with its subsidiaries or affiliates, has started the Phase IV Real World Data Registry trial ‘EVIDENCES- XI’, the company said in a filing to the stock exchanges on Friday.
This will include a total of around 1,500 male and female NAFLD patients having comorbidities like obesity, dyslipidemia, type 2 diabetes mellitus or metabolic syndrome.
The test will be conducted over a period of 56 weeks and the primary goal of the trial is to be able to measure the changes made in the stiffness of the liver as performed by transient elastography from Baseline to the 52nd week.
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 be leading this test, the pharmaceutical company said in a press release.
‘Phase 4 EVIDENCES’ is being considered among the largest ones including patients having Non-Alcoholic Steatohepatitis (NASH). It will lead to the generation of novel Real World Data (RWD) for patients having NAFLD or NASH, which is majorly lacking among the Asian population.
Shares of Zydus are trading 0.8 percent lower at Rs 508.95.
