Saroglitazar Improves Liver Health in Women With PCOS/PMOS

A clinical trial found that saroglitazar significantly reduced hepatic steatosis and improved liver enzyme levels in women with polycystic ovary syndrome (PCOS) – now known as polyendocrine metabolic ovarian syndrome (PMOS) – and metabolic dysfunction-associated steatotic liver disease (MASLD).

The findings suggest that the treatment may offer a potential therapeutic option for this population, which remains underrepresented in MASLD clinical trials.

Investigating Saroglitazar in PCOS

Researchers conducted a multicentre, randomised, double-blind, placebo-controlled Phase IIa trial involving 60 women aged 18–45 years with PMOS and MASLD.Participants were randomly assigned to receive either 4 mg of saroglitazar or placebo daily for 24 weeks.

The primary outcome was the relative change in hepatic fat content, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Researchers also assessed liver enzymes, lipid profiles, insulin resistance, and treatment safety.

Saroglitazar Reduced Hepatic Fat Content

At 24 weeks, participants receiving saroglitazar experienced a significant reduction in hepatic fat content compared with those receiving placebo. The relative change from baseline was −14.81% in the saroglitazar group, compared with an increase of 1.96% in the placebo group (p=0.041).

A greater proportion of participants receiving saroglitazar also achieved at least a 30% reduction in hepatic fat content compared with placebo.

Treatment was additionally associated with significant reductions in alanine aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase levels. Improvements were also observed in several lipid parameters, including triglycerides, very-low-density lipoprotein cholesterol, and apolipoprotein B.

The FibroScan-AST (FAST) score also decreased significantly in the saroglitazar group. However, there were no significant between-group differences in insulin resistance, body weight, or liver stiffness measurements.

Adverse events were comparable between the groups, with no serious treatment-emergent adverse events reported.

Clinical Implications

Researchers concluded that saroglitazar was well tolerated and improved hepatic steatosis, liver biochemistry, and atherogenic lipid parameters in reproductive-age women with PMOS and MASLD.

However, researchers highlighted the need for larger, longer-term studies to confirm the findings, assess the durability of treatment effects, and evaluate histological outcomes and longer-term cardiometabolic benefits.

Reference

Samala N et al. Saroglitazar improves hepatic steatosis and liver enzymes in women with polycystic ovary syndrome and MASLD: A multicenter, double-blind, placebo-controlled study. Hepatology.2026. DOI; 10.1097/HEP.0000000000001862.