Saroglitazar reduced liver fat in women with PCOS and fatty liver

Design

Phase 2a, randomised, double-blind, placebo-controlled, 24 weeks

Population

60 women aged 18-45 with PCOS and MASLD

Primary outcome

Relative change in MRI-PDFF liver fat

Effect

-14.8% vs +2.0% (p=0.041); ≥30% reduction 36.0% vs 8.7%

This phase 2a double-blind trial randomised 60 women aged 18 to 45 with polycystic ovary syndrome (PCOS) and metabolic dysfunction-associated steatotic liver disease (MASLD) to saroglitazar 4 mg or placebo for 24 weeks. Saroglitazar is a PPAR alpha/gamma agonist. Published in Hepatology on 15 October 2026.

In the per-protocol population (48 women), liver fat on MRI fell by about 15% relative to baseline with saroglitazar and rose by 2% with placebo (p=0.041). A 30% or greater reduction was reached by 36% versus 9%. Aminotransferases, lipids and FibroScan-AST scores also improved. Adverse events were similar and none were serious.

Women with PCOS are at high risk of fatty liver but are rarely included in MASLD trials. Saroglitazar was developed and approved in India, which makes this directly relevant here.

The trial was small, analysed per protocol, and measured liver fat rather than fibrosis or clinical outcomes. Pregnancy safety is not established.

• Screen women with PCOS for fatty liver, especially with obesity or insulin resistance
• Make weight loss and exercise the foundation of treatment
• Consider saroglitazar only after discussing that evidence in PCOS is early
• Advise reliable contraception, since pregnancy safety is not established
• Recheck liver enzymes and stiffness to judge response

Why it matters

A drug approved in India for fatty liver has early evidence in a group that is often left out of trials.

Don't overread it

Phase 2a, 48 women analysed, and liver fat is a surrogate; it does not show reduced fibrosis or liver events.

The statistics, in plain English

The difference in liver fat change was statistically significant (p=0.041) but based on a per-protocol analysis of 48 women, which can overstate benefit if dropouts differed between groups.

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