- Design
- Phase 2a, randomised, double-blind, placebo-controlled, 24 weeks
- Population
- 60 women with PCOS and MASLD (48 per-protocol)
- Primary outcome
- Relative change in MRI-PDFF liver fat
- Effect
- −14.8% vs +2.0% (P=0.041); ≥30% reduction 36% vs 9%
A phase 2a trial in Hepatology (15 October) randomised 60 women aged 18 to 45 with polycystic ovary syndrome and metabolic dysfunction-associated steatotic liver disease (MASLD) to saroglitazar 4 mg, a dual PPAR alpha/gamma agonist, or placebo for 24 weeks.
In the per-protocol analysis of 48 women, liver fat on MRI fell by about 15% with saroglitazar against a 2% rise with placebo; 36% against 9% achieved a 30% or greater reduction. Liver enzymes, lipids and a FibroScan-based score also improved. Adverse events were similar, with none serious.
Women with PCOS are under-represented in MASLD trials despite high rates of the disease. Saroglitazar is marketed in India, which makes the finding locally relevant, but this is a small phase 2a trial with an imaging endpoint and a per-protocol analysis. Contraception counselling matters with any PPAR agonist in women of reproductive age.
- Liver fat fell about 15% with saroglitazar versus a small rise with placebo at 24 weeks
- Liver enzymes and lipids also improved
- Screen women with PCOS for MASLD
- Discuss contraception: safety in pregnancy is not established
Why it matters
It is one of the few treatment trials in a group with a high and overlooked burden of fatty liver disease.
Don't overread it
Phase 2a, 48 analysed women, per-protocol and an imaging surrogate — no fibrosis or outcome data.
The statistics, in plain English
The primary result (P = 0.041) is only just significant, and the per-protocol analysis excludes those who dropped out, which can exaggerate benefit.
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