Zydus Lifesciences has announced positive topline results from its completed EVIDENCES-X™ Phase II(b) clinical trial evaluating Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis. The global, multicentre study enrolled 189 patients who were randomly assigned to receive either Saroglitazar 2 mg, Saroglitazar 4 mg or placebo. The treatment was administered over 52 weeks. The trial was prospective, randomized, double-blind and placebo-controlled, with liver biopsies used to assess treatment outcomes.
The study achieved its primary endpoint of resolution of steatohepatitis without worsening of fibrosis at week 52. The treatment difference was 26.5%. The trial also reported positive findings across several secondary and exploratory measures, including improvements in liver histology, steatosis, inflammation and ballooning. The EVIDENCES-X™ study was led by Prof Naga Chalasani, MD, Interim Chair, Department of Medicine, Indiana University School of Medicine, and Prof Arun J Sanyal, MD, Division of Gastroenterology, Virginia Commonwealth University, who served as co-Principal Investigators. Zydus said detailed findings from the trial will be presented at an upcoming Liver Congress. The company also plans to submit the data for publication in a peer-reviewed medical journal.
Dr Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said the completion of the Phase II(b) study and achievement of the primary endpoint represent an important milestone in the company’s 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,” he said.
MASH and Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) remain major health concerns worldwide. Experts estimate that about 25% of adults globally are affected by MASLD, while MASH is estimated to affect between 5% and 20% of adults.
MASH is a progressive form of MASLD marked by fat accumulation, inflammation and liver cell injury. The condition can progress to fibrosis, cirrhosis, liver failure, liver cancer and death. The latest findings build on earlier Phase II studies of Saroglitazar in patients with MASH and MASLD.
Saroglitazar Mg was approved by the Drug Controller General of India in 2020 for the treatment of MASH and MASLD in India. However, it remains an investigational compound in the United States and has not been approved by the U.S. Food and Drug Administration or the European Medicines Agency for MASH or MASLD.
Zydus Lifesciences is a global life sciences company involved in the discovery, development, manufacturing and marketing of healthcare products. The group employs more than 30,000 people worldwide, including around 1,500 scientists working in research and development.
