Saroglitazar reduces liver fat in phase 2A trial in women with PCOS

Women with polycystic ovary syndrome (PCOS) are underrepresented in therapeutic trials for metabolic dysfunction-associated steatotic liver disease (MASLD). In a multicenter, randomized, double-blind phase 2A trial published in Hepatology, 60 women aged 18–45 years with both conditions received saroglitazar 4 mg or placebo for 24 weeks. The primary endpoint was relative change in hepatic fat content measured by MRI proton-density fat-fraction (MRI-PDFF); the primary per-protocol analysis included 25 saroglitazar and 23 placebo recipients.

The least-squares mean relative change in liver fat was −14.81% with saroglitazar versus +1.96% with placebo (P=0.041). After adjustment for a baseline HbA1c imbalance, changes were −18.93% versus +6.43% (P<0.009). A reduction in MRI-PDFF of at least 30% occurred in 36.0% versus 8.7% of participants (P=0.025). Aminotransferases, lipid parameters and FAST score also decreased significantly with saroglitazar, although effect sizes were not provided in the supplied report.

Adverse events were comparable between groups, with none serious. One pregnancy in the saroglitazar group had uneventful maternal and neonatal outcomes; this isolated observation cannot establish pregnancy safety. The findings support further investigation rather than routine use in this population. Interpretation is limited by the small sample, per-protocol primary analysis, baseline HbA1c imbalance, short follow-up and reliance on surrogate rather than clinical liver outcomes.