News ArticleZydus Therapeutics' Saroglitazar Shows Significant Resolution of Steatohepatitis Without Fibrosis Worsening in Phase 2b Trial
Phase 2b data presented at AASLD 2026 reveals 39.1% resolution with 4 mg saroglitazar versus 13.7% with placebo in adults with MASH and fibrosis
Zydus Therapeutics announced Phase 2b trial results at AASLD 2026 demonstrating that saroglitazar achieved greater resolution of steatohepatitis without worsening fibrosis compared to placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) and stage F2-F3 fibrosis after 52 weeks. The treatment was generally well tolerated without significant weight gain.
Zydus Lifesciences Limited
General / Other
Zydus Therapeutics reported positive Phase 2b clinical trial results showing that saroglitazar magnesium significantly improved resolution of steatohepatitis without worsening fibrosis in adults with metabolic dysfunction-associated steatohepatitis (MASH) and stage F2–F3 fibrosis, compared to placebo, after 52 weeks of treatment.
The randomized, double-blind, placebo-controlled trial included 189 adults with biopsy-confirmed MASH and stage F2–F3 fibrosis, conducted across sites in Argentina, Turkey, and the United States.
Patients received either saroglitazar magnesium 4 mg, 2 mg, or placebo once daily for 52 weeks. Resolution of steatohepatitis without worsening fibrosis was achieved by 39.1% of patients on 4 mg, 32.4% on 2 mg, and 13.7% on placebo, showing statistically significant differences versus placebo.
Improvement in fibrosis by at least one stage without worsening of NAFLD Activity Score was numerically higher with 4 mg saroglitazar (34.8%) than placebo (24.6%), though this secondary endpoint did not reach statistical significance.
Non-invasive liver fibrosis markers like Pro-C3, APRI, FIB-4, and ADAPT showed favorable improvements with 4 mg saroglitazar compared to placebo.
Treatment was generally well tolerated, with no significant weight gain or drug-induced liver injury observed during the trial.
Highlights
- Phase 2b trial included 189 adults with biopsy-confirmed MASH and stage F2–F3 fibrosis.
- Resolution of steatohepatitis without fibrosis worsening: 39.1% with saroglitazar 4 mg vs. 13.7% with placebo (P=0.002).
- Numerical improvement in fibrosis without worsening NAFLD Activity Score with 4 mg dose but not statistically significant.
- Favorable changes in non-invasive liver fibrosis assessments with 4 mg saroglitazar.
- Treatment well tolerated, no significant weight gain or liver injury signal noted.
- Results presented at AASLD 2026 by Dr. Naga Chalasani.
Key Data Snapshot
What happened
- Zydus Therapeutics announced Phase 2b clinical trial results showing saroglitazar significantly resolved steatohepatitis without worsening fibrosis in MASH patients with stage F2–F3 fibrosis.
- Trial results were presented at the AASLD 2026 annual meeting by Dr. Naga Chalasani.
Key details
- The Phase 2b clinical trial was randomized, double-blind, and placebo-controlled with 189 patients enrolled across sites in Argentina, Turkey and the US.
- Saroglitazar doses tested were 4 mg and 2 mg, given once daily for 52 weeks.
- Primary endpoint was resolution of steatohepatitis without fibrosis worsening, which 39.1% of 4 mg and 32.4% of 2 mg patients achieved, versus 13.7% with placebo.
- Secondary endpoint of fibrosis improvement without worsening NAFLD Activity Score was numerically higher with 4 mg but did not reach statistical significance.
Regulatory and governance context
- Saroglitazar is an investigational product for MASH; safety and effectiveness for this use are not yet established.
- The study followed intention-to-treat analysis and included diabetic status stratification.
- Zydus Therapeutics is a clinical-stage biopharmaceutical company focused on treatments for serious liver diseases.
- Zydus Lifesciences is the parent company with a global presence in healthcare development and manufacturing.
Highlights
- Phase 2b trial included 189 adults with biopsy-confirmed MASH and stage F2–F3 fibrosis.
- Resolution of steatohepatitis without fibrosis worsening: 39.1% with saroglitazar 4 mg vs. 13.7% with placebo (P=0.002).
- Numerical improvement in fibrosis without worsening NAFLD Activity Score with 4 mg dose but not statistically significant.
- Favorable changes in non-invasive liver fibrosis assessments with 4 mg saroglitazar.
- Treatment well tolerated, no significant weight gain or liver injury signal noted.
- Results presented at AASLD 2026 by Dr. Naga Chalasani.
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