Clinical Trial Results Summary

Zydus Lifesciences Limited announced positive topline results from its completed EVIDENCES-X™ global Phase II(b) clinical trial of Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH).

Trial Design and Execution

  • The EVIDENCES-X™ trial was a prospective, multicentre, randomized, double-blind, placebo-controlled clinical trial
  • The liver biopsy-driven study enrolled 189 subjects randomized in a 1:1:1 ratio
  • Treatment groups: Saroglitazar 2 mg, Saroglitazar 4 mg, or placebo
  • Treatment period: 52 weeks
  • Geographic scope: Conducted across USA, Turkey, and Argentina
  • Principal Investigators: 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

Primary Endpoint Results

  • The trial successfully met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52
  • Achieved a treatment difference of 26.5%

Secondary and Exploratory Endpoints

  • The study demonstrated encouraging findings across key secondary and exploratory endpoints
  • Improvements observed in liver histology parameters, steatosis, inflammation and ballooning assessments
  • Further details will be presented at the upcoming Liver Congress

Regulatory Status and Background

  • Saroglitazar Mg was approved by the Drug Controller General of India (DCGI) for treatment of MASH and MASLD in India in 2020
  • Saroglitazar Mg remains an investigational compound in the United States and has not been approved by the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA) for MASH and MASLD treatment
  • The results build upon previously published findings from earlier Phase II studies of Saroglitazar in MASH and MASLD patients

Disease Context

  • Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) affects approximately 25% of adults worldwide
  • MASH affects an estimated 5% to 20% of the adult population
  • MASH is characterized by hepatic steatosis, inflammation, and hepatocellular injury
  • The disease can progress to advanced fibrosis, cirrhosis, liver failure, liver cancer, and death
  • MASH represents a significant unmet medical need globally with limited approved treatment options

Management Commentary

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, stated: "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."

Next Steps

  • Data from the EVIDENCES-X™ trial will be presented at upcoming scientific meetings
  • Results will be submitted for publication in a peer-reviewed medical journal

Company Background

Zydus Lifesciences Ltd. employs over 30,000 people worldwide, including 1,500 scientists engaged in R&D. The group has introduced several innovative, first-in class products over the last decade for treating unmet healthcare needs with vaccines, therapeutics, biologicals, and New Chemical Entities.