Zydus Saroglitazar Mg Trial Meets Primary Endpoint in MASH

Zydus Lifesciences announced positive topline results from its completed EVIDENCES-X™ Phase II(b) clinical trial for Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH). The trial successfully met its primary endpoint, demonstrating resolution of steatohepatitis with no worsening of fibrosis at 52 weeks, with a treatment difference of 26.5%. The study also showed improvements in key secondary and exploratory endpoints related to liver histology. MASH affects millions globally with limited treatment options. Saroglitazar Mg is already approved in India for MASH and MASLD and is an investigational compound in the US and Europe. These results reinforce the drug's therapeutic potential and Zydus' commitment to chronic liver disease treatments.