Saroglitazar for the Management of Diabetic Dyslipidemia and Non-Alcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis

Abstract

Background: Type 2 diabetes mellitus (T2DM) is often associated with diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD), both of which significantly increase the risk of cardiovascular and hepatic complications. Saroglitazar, a dual PPAR agonist, has emerged as a promising agent for addressing these metabolic abnormalities.

Aim: To systematically evaluate the efficacy and safety of Saroglitazar in improving lipid profile, glycemic control, liver enzymes, and hepatic steatosis in patients with T2DM and/or NAFLD.

Methods: A systematic review and meta-analysis were conducted in accordance with PRISMA 2020 guidelines. A comprehensive search of six major databases and gray literature sources identified relevant studies up to January 2025. Fourteen studies comprising 300 adult patients were included. Pooled mean differences and prevalence estimates were calculated using a random-effects model. Risk of bias was assessed using appropriate tools for randomized and observational studies.

Results: Saroglitazar significantly reduced triglyceride levels by –110.4 mg/dL (95% CI: –124.7 to –96.1), ALT by –28.8 U/L (95% CI: –33.4 to –24.2), HbA1c by –0.8% (95% CI: –1.0 to –0.6), and liver fat content by –7.5% (95% CI: –8.7 to –6.3); all with p < 0.001. The pooled prevalence of clinical response was 57.2% (95% CI: 49.0–65.4; I² = 29%). Adverse events were mild and infrequent, with no serious events reported.

Conclusion: Saroglitazar offers significant metabolic and hepatic benefits in patients with T2DM and/or NAFLD, with a favorable safety profile. It effectively improves lipid parameters, glycemic control, and liver health.

Recommendations: Saroglitazar may be considered in the therapeutic strategy for T2DM patients with dyslipidemia or NAFLD. However, larger randomized trials with long-term follow-up are recommended to confirm its long-term efficacy and safety.

Keywords: Saroglitazar, Diabetic Dyslipidemia, Non-Alcoholic Fatty Liver Disease, PPAR Agonist, Meta-Analysis