- Design
- Multicentre double-blind randomised placebo-controlled phase 2a trial
- Population
- 60 women aged 18–45 with PCOS and MASLD (48 per protocol)
- Primary outcome
- Relative change in MRI-PDFF liver fat at 24 weeks
- Effect
- −14.8% vs +2.0% (P = 0.041); ≥30% reduction in 36.0% vs 8.7%
This phase 2a double-blind trial randomised 60 women aged 18 to 45 with polycystic ovary syndrome and MASLD to saroglitazar 4 mg or placebo for 24 weeks. The primary analysis included 48 women who completed per protocol.
Liver fat on MRI fell by about 15% relative to baseline with saroglitazar, against a slight rise with placebo. More women on saroglitazar achieved a 30% or greater reduction (36% vs 9%). Liver enzymes, lipids and the FibroScan-AST score also improved. Adverse events were similar, and one pregnancy in the saroglitazar arm had a normal outcome.
Saroglitazar, a dual PPAR alpha/gamma agonist developed in India, is approved by CDSCO for diabetic dyslipidaemia and MASLD-related indications. Women with PCOS are rarely included in MASLD trials despite high prevalence.
The trial was small, short and analysed per protocol, and fat fraction is a surrogate. Safety in women trying to conceive is not established.
- Screen women with PCOS for MASLD, particularly those with obesity or insulin resistance.
- Keep weight loss and metabolic risk management as first-line treatment for MASLD in PCOS.
- Discuss contraception if prescribing saroglitazar to women of reproductive age, as pregnancy safety is unknown.
- Treat this as early-phase evidence on a surrogate end point.
Why it matters
It addresses a group with high MASLD risk that trials usually leave out.
Don't overread it
Phase 2a, per-protocol, surrogate end point; it does not show less fibrosis or better outcomes.
The statistics, in plain English
The relative fat reduction of about 15% versus a 2% rise had a P value of 0.041, only just significant in 48 women. Per-protocol analysis can overstate benefit if dropouts differ between arms.
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