According to reports from CNBC TV18, Zydus Lifesciences announced that its wholly owned subsidiary Zydus Therapeutics reported significant results from a Phase 2b clinical trial of investigational drug saroglitazar. The trial demonstrated that 39.1% of patients receiving saroglitazar magnesium 4 mg and 32.4% of those receiving the 2 mg dose achieved higher rates of steatohepatitis resolution without worsening of liver fibrosis in adults with metabolic dysfunction-associated steatohepatitis (MASH), 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, with the 4 mg dose showing statistically significant results (P=0.002).
As reported by CNBC TV18, the results come 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. The trial was conducted at sites in Argentina, Turkey and the United States, with statistical analyses using intention-to-treat population and missing-at-random methodology. The results were presented as a late-breaking oral presentation at The Liver Meeting 2026, hosted by the American Association for the Study of Liver Diseases (AASLD).
According to CNBC TV18, 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, with a treatment difference of 10.2 percentage points but not reaching statistical significance. The 4 mg dose also showed favourable improvements in non-invasive assessments of liver fibrosis, with treatment differences of -9.50 ng/mL for Pro-C3, -0.35 for AST to Platelet Ratio Index (APRI), -0.30 for Fibrosis-4 Index (FIB-4), and -0.53 for ADAPT score. These metrics suggest a reduction in liver inflammation and fibrosis progression, supporting the clinical findings from biopsy data.
As reported by CNBC TV18, saroglitazar was generally well tolerated during the trial, with no significant weight gain or drug-induced liver injury signal. Naga Chalasani, David W. Crabb Professor of Gastroenterology and Hepatology, noted that many people with MASH and fibrosis also have type 2 diabetes or obesity, requiring options that address both liver disease and metabolic dysfunction. He emphasized that the Phase 2b trial showed a higher proportion of patients achieving resolution of steatohepatitis without worsening of fibrosis with saroglitazar than with placebo, with improvements in lipid and glycemic parameters observed alongside the primary efficacy results.
According to CNBC TV18, 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). Zydus Therapeutics is evaluating saroglitazar as a potential treatment for adults with MASH and fibrosis, with the company noting that saroglitazar is an investigational product for MASH and its safety and effectiveness for this use have not been established. Shares of Zydus Lifesciences Ltd ended at ₹1,195.00, down by ₹1.40, or 0.12% on the BSE following the announcement. The company stated that these results support evaluating saroglitazar in larger, longer-term studies, while saroglitazar is currently under investigation for Primary Biliary Cholangitis (PBC) and has received Orphan Drug Designation and Fast Track Designation from the US FDA for that indication.
