
Zydus Lifesciences has commenced a Phase IV real-world data registry trial called "Phase IV EVIDENCES-XI" to investigate the benefits of Saroglitazar Magnesium in patients with nonalcoholic fatty liver disease (NAFLD) and comorbidities. This trial aims to enrol 1,500 male and female NAFLD patients with comorbidities such as obesity, type 2 diabetes mellitus, dyslipidemia, or metabolic syndrome, with 200 patients in each category. The study duration is expected to be around 56 weeks. The trial's primary objective is to assess the change in liver stiffness from baseline to the 52nd week. Saroglitazar Magnesium has already shown beneficial effects in reducing liver fat content in NAFLD patients. The study is anticipated to generate valuable real-world data on NAFLD and nonalcoholic steatohepatitis (NASH) patients, particularly in Asian populations with limited information.
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