India, Aug. 31 -- 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 multicentre, randomized, double-blind, placebo-controlled trial enrolled 189 patients, who were divided equally into three groups receiving Saroglitazar 2 mg, Saroglitazar 4 mg or placebo for 52 weeks.
The study met its primary endpoint, demonstrating resolution of steatohepatitis without worsening of fibrosis at week 52, with a treatment difference of 26.5%. The trial also showed positive results across several secondary and exploratory measures, including improvements in liver histo...