Zydus Therapeutics, a subsidiary of Zydus Lifesciences, announced positive results from its Phase 2b randomized trial of saroglitazar for MASH and fibrosis. The study demonstrated a significant resolution of steatohepatitis without worsening of fibrosis in patients treated with saroglitazar compared to placebo. The drug was generally well-tolerated, showing no significant weight gain or drug-induced liver injury signals.
Positive Clinical Trial Outcomes
Zydus Therapeutics Inc., a subsidiary of Zydus Lifesciences Limited, has revealed positive results from its Phase 2b randomized, double-blind, placebo-controlled clinical trial of saroglitazar. The trial focused on adults with biopsy-confirmed Metabolic Dysfunction-Associated Steatohepatitis (MASH) and stage F2-F3 fibrosis. These findings are set to be presented at The Liver Meeting® 2026, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).
Key Efficacy Data
The primary endpoint of the study was the resolution of steatohepatitis without worsening of fibrosis. Results showed that 39.1% of patients receiving 4 mg of saroglitazar magnesium and 32.4% receiving 2 mg achieved this outcome, compared to only 13.7% in the placebo group. These statistically significant improvements highlight the potential of saroglitazar in treating MASH.
Safety and Tolerability Profile
Saroglitazar was observed to be generally well-tolerated throughout the 52-week treatment period. The trial reported no significant weight gain among patients, nor did it show any signals of drug-induced liver injury. This favorable safety profile is crucial for an investigational treatment targeting chronic liver conditions.
Study Details
The EVIDENCES X trial (NCT05011305) enrolled 189 adults aged 18-75 years with biopsy-confirmed MASH and stage F2-F3 fibrosis. Participants were randomized to receive either 4 mg saroglitazar magnesium, 2 mg saroglitazar magnesium, or placebo, once daily for 52 weeks. The trial was conducted across sites in Argentina, Turkey, and the United States.
About Saroglitazar and MASH
Saroglitazar is a novel Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist. It is currently under investigation for MASH and Primary Biliary Cholangitis (PBC). MASH, previously known as NASH, is a progressive liver disease characterized by fat accumulation, inflammation, and liver cell injury, which can lead to fibrosis, cirrhosis, and potentially liver failure. Saroglitazar’s unique mechanism targets both bile acid toxicity and liver inflammation, offering a dual approach to managing the disease.
Source: BSE
