Zydus randomises 'first patient' in phase 2 trial of Saroglitazar Mg in NASH

Ahmedabad: Zydus, a global pharmaceutical company has recently announced that the company has randomised the first patient into the Phase 2(b) Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled clinical trial to evaluate efficacy and safety of Saroglitazar Magnesium in subjects with Non-Alcoholic Steatohepatitis and Fibrosis.

Zydus had earlier received permission from the USFDA. The EVIDENCES-X liver biopsy driven Phase 2(b) trial will be led by Prof. Naga Chalasani, M.D., Interim Chair, Department of Medicine, Indiana University School of Medicine and Prof. Arun J. Sanyal, M.D., Division of Gastroenterology, Virginia Commonwealth University as co-Principal Investigators. The EVIDENCES-X trial will randomise 240 subjects in a 1:1:1 ratio to Saroglitazar 2 mg, Saroglitazar 4 mg or Placebo and study the primary endpoint

"Resolution of steatohepatitis with no worsening of fibrosis" over a period of 76 weeks. The secondary end-points will include improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis, 2 points improvement in NAS, Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy, Histological score changes in steatosis, ballooning, inflammation and fibrosis.