Zydus Lifesciences has announced positive topline results from its global Phase II(b) EVIDENCES-X clinical trial evaluating Saroglitazar Magnesium (Saroglitazar Mg) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.

The multicentre, randomised, double-blind, placebo-controlled study enrolled 189 patients, who were randomised in a 1:1:1 ratio to receive Saroglitazar Mg 2 mg, Saroglitazar Mg 4 mg or placebo over 52 weeks.

The trial met its primary endpoint of resolution of steatohepatitis without worsening of fibrosis at week 52, demonstrating a treatment difference of 26.5%.

In addition to the primary endpoint, the study reported encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology, steatosis, inflammation and hepatocellular ballooning.

Zydus said detailed findings from the EVIDENCES-X trial will be presented at an upcoming Liver Congress and submitted for publication in 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, who served as co-Principal Investigators. The study enrolled patients across the US, 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.”

MASH is a progressive form of metabolic liver disease characterised by hepatic steatosis, inflammation and hepatocellular injury and can progress to advanced fibrosis, cirrhosis, liver failure and hepatocellular carcinoma.

The company noted that MASLD and MASH represent significant unmet medical needs globally, with MASLD estimated to affect approximately 25% of adults worldwide, while MASH affects an estimated 5% to 20% of the adult population. 

The EVIDENCES-X results add to Zydus’ earlier clinical data evaluating Saroglitazar in MASH and MASLD and support the company’s ongoing global development programme for the drug in chronic liver diseases. 

Saroglitazar Mg received approval from the Drug Controller General of India (DCGI) for the treatment of MASH and MASLD in India in 2020. However, the drug remains investigational in the US and has not been approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH or MASLD.