Comparative Effects of Saroglitazar, Vitamin E and Lifestyle Modification on Liver Fibrosis Markers in Metabolic Dysfunction-Associated Steatotic Liver Disease

Abstract

Introduction: This study presents the effects of metabolic dysfunction-associated steatotic liver disease (MASLD), which is a global health issue. It is related with obesity, metabolic dysfunction, and progressive liver fibrosis. In order to prevent this issue, it requires an effective treatment plan. This study assessed the effect of Saroglitazar, Vitamin E, and lifestyle modification on liver fibrosis markers and metabolic parameters in patients with MASLD/metabolic dysfunction-associated steatohepatitis (MASH).

Methods: This investigator-initiated, prospective, randomised study was conducted among 170 patients from May 2025 to April 2026 in our hospital. 170 participants were divided into three groups: Saroglitazar (n=60), Vitamin E (n=60), and Only Lifestyle group (n=50). Each parameter was measured at baseline and after 24 weeks.

Results: Baseline characteristics were comparable across the Saroglitazar (n=60), Vitamin E (n=60), and Lifestyle (n=50) groups. Median age (33–35 years; p=0.72), male distribution (86–88%; p=0.91), anthropometric measures, and all baseline laboratory parameters showed no significant differences (all p>0.05). After 24 weeks, improvements were observed across all groups, with significant between-group differences only for triglyceride reduction, which was greatest with Saroglitazar (−14.2 vs. −4.5 vs. −13.5 mg/dL; p=0.034). The proportion achieving ≥2 kPa liver stiffness reduction was highest with Saroglitazar (40%), followed by Vitamin E (35%) and Lifestyle intervention (20%), with Saroglitazar significantly outperforming Lifestyle intervention (p=0.028).

Conclusion: The study concluded that the Saroglitazar showed improvement in the triglyceride levels and liver stiffness response, while all other three interventions showed similar improvement in the fibrosis and the functional marker for liver.