Zydus Therapeutics, a subsidiary of Zydus Lifesciences Limited, has announced encouraging results from its Phase 2b clinical trial of saroglitazar in adults with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. The findings, presented at the American Association for the Study of Liver Diseases (AASLD) 2026 meeting, indicate that saroglitazar may significantly improve liver health without worsening fibrosis.
The trial, known as EVIDENCES X, assessed the efficacy and safety of saroglitazar magnesium at doses of 2 mg and 4 mg, compared to a placebo, over a 52-week period. The study involved 189 participants from Argentina, Turkey, and the United States, all of whom had biopsy-confirmed MASH and stage F2–F3 fibrosis. The primary endpoint was the resolution of steatohepatitis without worsening fibrosis. Results showed that 39.1% of patients receiving 4 mg and 32.4% of those on 2 mg achieved this outcome, compared to just 13.7% in the placebo group.
In addition to the primary endpoint, the trial also evaluated secondary outcomes, including improvements in liver fibrosis and metabolic parameters. While the 4 mg dose showed a numerically higher improvement in fibrosis compared to placebo, it did not reach statistical significance. However, saroglitazar demonstrated favourable effects on non-invasive liver fibrosis assessments and was generally well tolerated, with no significant weight gain or liver injury signals reported.
Dr. Naga Chalasani, a leading expert in gastroenterology and hepatology, highlighted the potential of saroglitazar to address both liver disease and associated metabolic dysfunctions, such as type 2 diabetes and obesity. He noted that the trial results support further investigation of saroglitazar in larger, longer-term studies.
Zydus Therapeutics continues to explore saroglitazar as a treatment option for MASH, although its safety and efficacy for this indication have not yet been established. The trial’s findings contribute to the ongoing research into effective therapies for MASH, a condition that poses significant clinical and economic challenges globally. Analysts suggest that if future studies confirm these results, saroglitazar could become a valuable tool in managing MASH and its complications.
