Ahmedabad, Gujarat, India, and Pennington, New Jersey, USA, November 6, 2026

Zydus Therapeutics, Inc., a wholly owned subsidiary of Zydus Lifesciences Limited, has announced encouraging Phase 2b clinical results for its investigational drug candidate saroglitazar magnesium in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis. The findings demonstrate significantly greater resolution of steatohepatitis without worsening of liver fibrosis compared with placebo following 52 weeks of treatment. The results were announced ahead of a late-breaking oral presentation at The Liver Meeting® 2026, organized by the American Association for the Study of Liver Diseases (AASLD). The EVIDENCES X clinical trial evaluated two once-daily doses of saroglitazar magnesium, 2 mg and 4 mg, in patients with biopsy-confirmed MASH and stage F2–F3 fibrosis. According to the primary analysis, 39.1% of patients receiving the 4 mg dose and 32.4% receiving the 2 mg dose achieved MASH resolution without worsening of fibrosis, compared with 13.7% of patients receiving placebo. These findings highlight the potential of saroglitazar as an investigational treatment for patients with progressive metabolic liver disease.

Phase 2b EVIDENCES X Trial Demonstrates Significant MASH Resolution

The randomized, double-blind, placebo-controlled Phase 2b EVIDENCES X trial enrolled 189 adults with biopsy-confirmed MASH and stage F2–F3 liver fibrosis. Participants were randomized into three treatment groups, receiving saroglitazar magnesium 4 mg, saroglitazar magnesium 2 mg or placebo once daily for 52 weeks. The primary endpoint was resolution of steatohepatitis without worsening of liver fibrosis. Results showed that 39.1% of patients in the 4 mg treatment group achieved the primary endpoint, compared with 32.4% in the 2 mg group and 13.7% in the placebo group. The treatment difference versus placebo was 24.9 percentage points for the 4 mg dose (p=0.002) and 16.5 percentage points for the 2 mg dose (p=0.033). Both treatment groups demonstrated statistically significant improvements over placebo. The trial also evaluated improvement in liver fibrosis by at least one stage without worsening of the NAFLD Activity Score (NAS). This secondary endpoint was achieved by 34.8% of patients receiving saroglitazar 4 mg compared with 24.6% receiving placebo. However, the difference in this secondary endpoint did not reach statistical significance. The 2 mg treatment group demonstrated a fibrosis improvement response rate of 22.8%. These results provide important clinical evidence supporting further investigation of saroglitazar in MASH.

Saroglitazar Shows Improvements in Liver Fibrosis Markers

Beyond the primary histological endpoint, saroglitazar demonstrated encouraging improvements in several non-invasive biomarkers associated with liver inflammation and fibrosis. Patients receiving the 4 mg dose experienced favorable changes in Pro-C3, AST-to-Platelet Ratio Index (APRI), Fibrosis-4 Index (FIB-4) and ADAPT scores compared with placebo. The treatment difference in Pro-C3 was -9.50 ng/mL, while APRI and FIB-4 showed treatment differences of -0.35 and -0.30, respectively. The ADAPT score also improved, with a treatment difference of -0.53. These biomarkers are used to assess different aspects of liver fibrosis and disease progression. The findings suggest that saroglitazar may influence several biological processes associated with MASH and liver damage. The treatment was generally well tolerated, with no significant weight gain or drug-induced liver injury signal reported during the study. According to the clinical investigators, improvements were also observed in lipid and glycemic parameters, supporting the potential relevance of saroglitazar for patients who frequently experience metabolic complications alongside liver disease. The findings were presented by Naga Chalasani, MD, FAASLD, David W. Crabb Professor of Gastroenterology and Hepatology, at the 2026 AASLD meeting.

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Zydus Advances Saroglitazar Clinical Development

Saroglitazar is an investigational peroxisome proliferator-activated receptor (PPAR) alpha/gamma agonist designed to influence lipid metabolism, glucose regulation and inflammatory pathways. The dual-receptor mechanism provides a potential therapeutic approach for metabolic diseases involving liver fat accumulation, inflammation and fibrosis. Zydus Therapeutics is continuing to evaluate saroglitazar as a potential treatment for MASH and other serious liver disorders, including primary biliary cholangitis (PBC). The company has also received FDA Orphan Drug Designation, Fast Track Designation and Priority Review for saroglitazar in PBC. Importantly, saroglitazar remains investigational for MASH in the United States, and its safety and effectiveness for this indication have not been established by the FDA. Larger and longer-duration clinical studies will be necessary to confirm its therapeutic benefits and long-term safety profile.

Overall, Zydus Therapeutics’ Phase 2b EVIDENCES X results represent an encouraging advancement in investigational MASH treatment development. The statistically significant improvement in steatohepatitis resolution, together with favorable changes in liver biomarkers, supports continued clinical evaluation of saroglitazar in patients with moderate-to-advanced liver fibrosis.

Source: Zydus Therapeutics press release