Drug firm Zydus Lifesciences Ltd on Friday (November 6) said its wholly owned subsidiary, Zydus Therapeutics, announced results from a Phase 2b clinical trial showing that its investigational drug saroglitazar achieved higher rates of steatohepatitis resolution without worsening of liver fibrosis in adults with metabolic dysfunction-associated steatohepatitis (MASH), compared with placebo.
The primary endpoint was achieved by 39.1% of patients receiving saroglitazar magnesium 4 mg and 32.4% of those receiving the 2 mg dose, compared with 13.7% of patients in the placebo group after 52 weeks of treatment. The treatment differences versus placebo were 24.9 percentage points for the 4 mg dose and 16.5 percentage points for the 2 mg dose.
The results are from a randomised, double-blind, placebo-controlled Phase 2b clinical trial involving 189 adults with biopsy-confirmed MASH and stage F2–F3 fibrosis. The study evaluated the efficacy and safety of saroglitazar magnesium at 2 mg and 4 mg doses, administered once daily for 52 weeks, compared with placebo. The primary endpoint was resolution of steatohepatitis without worsening of fibrosis.
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The findings will be presented as a late-breaking oral presentation at The Liver Meeting 2026, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The presentation is titled Saroglitazar Magnesium Achieves Resolution of Steatohepatitis Without Worsening Fibrosis in Patients with MASH: Results of a Randomised, Placebo-Controlled Phase 2b Trial (EVIDENCES X).
Naga Chalasani, David W. Crabb Professor of Gastroenterology and Hepatology and co-editor-in-chief of HEPATOLOGY, will deliver the presentation. The study was conducted at sites in Argentina, Turkey and the United States.
Fibrosis improvement and secondary endpoint
The trial also evaluated improvement in fibrosis by at least one stage without worsening of the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS), a secondary endpoint.
The response rate for this measure was 34.8% among patients receiving saroglitazar magnesium 4 mg, compared with 24.6% in the placebo group. The treatment difference was 10.2 percentage points but did not reach statistical significance. The response rate among patients receiving the 2 mg dose was 22.8%.
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The 4 mg dose also showed favourable improvements in non-invasive assessments of liver fibrosis compared with placebo. The treatment difference was -9.50 ng/mL for Pro-C3, with a 95% confidence interval (CI) of -15.3 to -3.7.
The corresponding treatment differences were -0.35 for the AST to Platelet Ratio Index (APRI), with a 95% CI of -0.5 to -0.2; -0.30 for the Fibrosis-4 Index (FIB-4), with a 95% CI of -0.5 to -0.1; and -0.53 for the ADAPT score, with a 95% CI of -1.0 to -0.1.
Safety profile and clinical observations
Saroglitazar was generally well tolerated during the trial, with no significant weight gain or drug-induced liver injury signal. Chalasani said, “Many people with MASH and fibrosis also have type 2 diabetes or obesity, so we need options that address both the liver disease and the metabolic dysfunction that drives it.”
He added that the Phase 2b trial showed a higher proportion of patients achieving resolution of steatohepatitis without worsening of fibrosis with saroglitazar than with placebo. “In this Phase 2b trial, more patients achieved resolution of steatohepatitis without worsening of fibrosis with saroglitazar than with placebo,” he said.
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Chalasani also referred to improvements in metabolic parameters observed in the study, saying the results came “along with improvements in lipid and glycemic parameters”. “These results support evaluating saroglitazar in larger, longer-term studies,” he said.
Zydus evaluating saroglitazar for MASH
Zydus Therapeutics is evaluating saroglitazar as a potential treatment for adults with MASH and fibrosis. The company said saroglitazar is an investigational product for MASH, and its safety and effectiveness for this use have not been established.
The statistical analyses used the intention-to-treat population and a missing-at-random methodology. The analyses were also stratified by patients’ baseline diabetes status.
The Phase 2b results provide data on the efficacy and safety of both saroglitazar magnesium doses against placebo over the 52-week treatment period. While the primary endpoint showed higher response rates with both doses, the improvement in fibrosis by at least one stage for the 4 mg dose did not reach statistical significance.
Shares of Zydus Lifesciences Ltd ended at ₹1,195.00, down by ₹1.40, or 0.12%, on the BSE.
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