Saroglitazar was associated with improvements in liver stiffness, hepatic steatosis, metabolic parameters and non-invasive fibrosis markers in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to a recent Indian study.

This study was published in the February 2026 issue of Liver International.

MASLD is a growing global health concern and encompasses a spectrum of liver disorders characterised by excessive hepatic fat accumulation associated with metabolic dysfunction. In India, reported prevalence of MASLD was 68.2% (CAP ≥ 238 dB/m), and 33.7% for fibrosis (LSM ≥ 7 kPa)1. Its pathogenesis involves hepatic steatosis, lipotoxicity, inflammation and fibrogenesis driven by complex metabolic and endocrine pathways. This has led to the exploration of therapies targeting key regulators such as peroxisomes proliferator-activated receptors (PPARs) that address both liver and metabolic abnormalities.

Saroglitazar is a dual peroxisome proliferator-activated receptor (PPAR)-α/γ agonist. Through PPAR-α activity, it has lipid-modulating effects, while PPAR-γ activity improves insulin sensitivity and glycaemic control, supporting its potential role and evaluation in MASLD.

Study Overview

A prospective, multicentre, single-arm, real-world Phase 4 study2 evaluated saroglitazar 4 mg orally once daily for 52 weeks in patients with MASLD. The interim analysis included 500 patients who had completed 24 weeks of treatment. The mean age was 45.7 ± 11.6 years, 69% of patients were male, and the mean BMI was 29.9 ± 4.7 kg/m². Obesity was the most common metabolic comorbidity (42%), followed by dyslipidaemia (20%), type 2 diabetes mellitus (20%) and metabolic syndrome (18%).

The primary endpoint was change in liver stiffness measurement (LSM) from baseline to Week 52, along with the incidence of treatment-emergent and serious adverse events. Secondary assessments included changes in LSM, CAP, UAP, liver enzymes, HbA1c, fasting glucose, weight, BMI and lipid profile at Weeks 24 and 52. However, the published interim analysis reports the findings from the 24-week assessment.

Some of the key results of the study2 include:

Effect on Liver Stiffness and Steatosis

At Week 24, mean LSM decreased by 2.1 kPa (-20.7%), from 10.1 ± 3.17 kPa to 8.0 ± 3.2 kPa (p<0.001), with 32.6% (n=494) of patients achieving ≥30% reduction. CAP decreased by 20.3 dB/m(n=309) and UAP by 22.3 dB/m (n=182) (p<0.001 for both).

Effect on Liver Enzymes and Glycaemic Parameters

Mean ALT levels decreased by -33.6% from 59.8 ± 39.5 U/L to 39.7 ± 32.9 U/L and AST by -19.6% from 48.9 ± 26.7 U/L to 39.3 ± 21.7 U/L (p<0.001 for both). Among patients with baseline ALT ≥ 40 U/L, 61% achieved ALT normalisation. HbA1c decreased from 6.3% to 6.0%, while fasting glucose decreased from 118.07 ± 44.79 mg/dL to 112.06 ± 46.81 mg/dL.

Effect on Lipid Profile