Saroglitazar Achieves MASH Resolution in Global Phase IIb Trial: EVIDENCES-X | August 2026

Introduction:

Saroglitazar, a PPAR-α/γ agonist already used for MASLD/MASH in India, is being developed internationally as a potential treatment for MASH with fibrosis. The global EVIDENCES-X trial evaluated its histologic efficacy after 52 weeks of treatment.

Why was this study needed?

MASH with fibrosis remains a major therapeutic challenge.

Saroglitazar has demonstrated metabolic and liver-related benefits in earlier studies.

Its efficacy required confirmation using biopsy-based regulatory endpoints in a global population.

International development requires evidence beyond its existing clinical use in India.

Key Findings:

189 patients with MASH and fibrosis were randomised to saroglitazar 2 mg, 4 mg, or placebo for 52 weeks.

The study met its biopsy-based primary endpoint of MASH resolution without worsening of fibrosis.

The company reported a 26.5-percentage-point treatment difference versus placebo.

Improvements were also reported in steatosis, lobular inflammation, hepatocyte ballooning, and other histologic parameters.

Detailed dose-specific efficacy results have not yet been disclosed.

The magnitude of fibrosis improvement and complete safety data also remain unavailable.

These are currently topline company-reported results, with full scientific presentation still awaited.

Bottom Line:

Saroglitazar has achieved biopsy-confirmed MASH resolution without worsening fibrosis in a global Phase IIb trial. The results strengthen its international development potential, but full efficacy and safety data are needed before judging its place in MASH therapy.