Regulatory Disclosure Summary

Key Clinical Trial Results

The Phase 2b randomized, double-blind, placebo-controlled clinical trial (EVIDENCES X, NCT05011305) evaluated saroglitazar magnesium in adults with biopsy-confirmed MASH and stage F2–F3 fibrosis:

Primary Endpoint Results:

  • Resolution of steatohepatitis without worsening of fibrosis after 52 weeks of treatment
  • 39.1% of patients receiving saroglitazar magnesium 4 mg achieved primary endpoint
  • 32.4% of patients receiving saroglitazar magnesium 2 mg achieved primary endpoint
  • 13.7% of patients receiving placebo achieved primary endpoint
  • Treatment differences versus placebo: 24.9% (95% CI, 9.5–40.3; P=0.002) for 4 mg and 16.5% (95% CI, 1.3–31.6; P=0.033) for 2 mg

Secondary Endpoint Results:

  • Improvement in fibrosis by at least one stage without worsening of NAFLD Activity Score (NAS)
  • 34.8% with 4 mg vs. 24.6% with placebo (treatment difference 10.2%, not statistically significant)
  • 22.8% with 2 mg

Non-Invasive Assessment Improvements (4 mg vs placebo):

  • Pro-C3: −9.50 ng/mL (95% CI, −15.3 to −3.7)
  • APRI: −0.35 (95% CI, −0.5 to −0.2)
  • FIB-4: −0.30 (95% CI, −0.5 to −0.1)
  • ADAPT: −0.53 (95% CI, −1.0 to −0.1)

Safety Profile

Saroglitazar was generally well tolerated without significant weight gain or drug-induced liver injury signal.

Trial Design Details

  • Multicenter trial conducted at sites in Argentina, Turkey, and the United States
  • 189 participants aged 18–75 years randomized 1:1:1
  • Treatment groups: saroglitazar magnesium 4 mg (n=64), 2 mg (n=63), placebo (n=62)
  • 52-week treatment duration
  • Analysis used intention-to-treat population with missing-at-random methodology
  • Stratified by baseline diabetes status

Product Status

Saroglitazar is an investigational Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist currently under investigation for MASH and Primary Biliary Cholangitis (PBC). The drug has received Orphan Drug Designation, Fast Track Designation, and Priority Review from the US FDA for PBC treatment. Safety and effectiveness for MASH use have not been established.

Presentation Details

Results were presented as a late-breaking oral presentation at The Liver Meeting® 2026 (AASLD annual meeting) by Naga Chalasani, MD, FAASLD, David W. Crabb Professor of Gastroenterology and Hepatology.

Corporate Structure

Zydus Therapeutics Inc. is identified as a wholly owned subsidiary of Zydus Lifesciences Limited, headquartered in Pennington, New Jersey, focused on developing treatments for rare and serious liver diseases.

Forward-Looking Statements

The disclosure contains standard forward-looking statements under the Private Securities Litigation Reform Act of 1995, noting that actual results could differ from expectations and the company does not commit to updating statements unless required by law.