Zydus Lifesciences Limited announced positive topline results from its completed EVIDENCES-X™ global Phase II(b) clinical trial evaluating Saroglitazar Magnesium (Saroglitazar Mg) in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis.
The multicentre, randomized, double-blind, placebo-controlled study enrolled 189 subjects, who were randomized equally to receive Saroglitazar 2 mg, Saroglitazar 4 mg or placebo for 52 weeks. The trial met its primary endpoint of resolution of steatohepatitis without worsening of fibrosis at week 52, recording a treatment difference of 26.5%.
The study also reported encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology parameters and measures of steatosis, inflammation and ballooning. Detailed findings will be presented at an upcoming Liver Congress and submitted to a peer-reviewed medical journal.
The trial was 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. Patients were enrolled across the United States, Turkey and Argentina.
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said: “The successful completion of the EVIDENCES-X™ Phase II(b) trial and achievement of the primary endpoint marks an important milestone in our MASH development programme. These results reinforce the therapeutic potential of Saroglitazar Mg and our commitment to developing innovative treatment options for patients suffering from chronic liver diseases.”
The results add to evidence from earlier Phase II studies and support Zydus’ ongoing global development programme for Saroglitazar Mg in chronic liver diseases.
Saroglitazar Mg was approved by India’s DCGI for MASH and MASLD in 2020. It remains investigational in the US and has not been approved by the FDA or EMA for MASH or MASLD.
