Zydus Lifesciences has commenced Phase of IV Real World Data Registry trial ‘EVIDENCES- XI’ for Saroglitazar Magnesium in NAFLD patients with comorbidities (ClinicalTrials.gov Identifier: NCT05872269).
The Phase IV EVIDENCES- XI trial will enroll around 1500 male and female NAFLD patients with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome- 200 patients each). The study duration is around 56 weeks. The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
