# Impact of Saroglitazar on Liver Stiffness Measurements in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) With Compensated Cirrhosis: A Single-Arm Study

## TL;DR

This study examines the effects of Saroglitazar on liver stiffness in patients with a specific type of liver disease and finds it to be safe with some improvements in liver health markers.

## Contribution

The study provides new insights into the safety and effects of Saroglitazar in MASLD with compensated cirrhosis.

## Key findings

- Saroglitazar reduced liver fat content and improved several biochemical markers in patients with MASLD-CC.
- Liver stiffness measurements showed a slight decrease, but changes were not significantly different between groups.
- The drug was generally safe, with only minor adverse events reported.

## Abstract

Background

Saroglitazar, a dual peroxisome proliferator-activated receptor α/γ agonist, shows promise in metabolic dysfunction-associated steatotic liver disease (MASLD). However, its impact and safety in MASLD with compensated cirrhosis (MASLD-CC) remain relatively unexplored.

Methods

In a single-center, single-arm retrospective study, we assessed the impact of Saroglitazar (4 mg for 24 weeks) on liver stiffness measurement (LSM) by magnetic resonance elastography (MRE) in MASLD-CC and evaluated safety and effects on biochemical indices and liver fat content (LFC) by MRI-proton density fat fraction (MRI-PDFF). To distinguish measurement error from true change, a threshold of 0.75 kPa for MRE-LSM was used to categorize LSM progressors and regressors.

Results

Twenty-six patients with MASLD-CC (age 61 (58-64) years; 61.5% female; BMI 28.7 ± 3.3 kg/m²; 88.4% obese; 76.9% with diabetes) completed 24 weeks of follow-up. Body weight (69.5 (64-75) vs 68.3 (66-71) kg, p = 0.02), alanine transaminase (42.5 (30-61) vs 22.5 (20-36) U/L), aspartate transaminase (53 (39-74) vs 40 (33-49) U/L), fasting blood sugar (109 (100-129.5) vs 100.5 (96.3-108.3) mg/dL), total cholesterol (157 (139.5-171) vs 140 (120-167) mg/dL), triglycerides (121 (95-153) vs 100 (94-113.5) mg/dL), and LFC (7.2 (6.9-11.1) vs 5.1 (3.5-6.1) %) decreased with Saroglitazar (p < 0.01 for all). A decrease in MRE-LSM (5.4 (4.9-6.2) vs 5.1 (4.9-5.8) kPa) was seen in the overall cohort (p = 0.04). However, only 4 (15.3%) and 2 (7.6%) showed MRE-LSM regression and progression of ≥ 0.75 kPa, respectively. No differences were noted between regressors and progressors using the 0.75 kPa threshold (23.5% vs 22.2%, p = 0.91). Two patients (pruritus and increased urine frequency) reported adverse events.

Conclusion

Saroglitazar use over 24 weeks in MASLD-CC appears safe. Using pragmatic thresholds, changes in liver stiffness over 24 weeks did not differ significantly. Larger prospective studies with longer follow-up are warranted.