Effectiveness of Saroglitazar in MASLD Patients: A Prospective, Real-World Assessment of Liver and Metabolic Health

Abstract

Background: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a significant health concern and is commonly associated with conditions such as dyslipidemia, insulin resistance, and increased risk of cardiovascular disease. Managing MASLD requires addressing both liver and metabolic dysfunction. Saroglitazar, a dual PPARα/γ agonist, has shown potential in addressing liver steatosis, fibrosis, and dyslipidemia.

Methodology: This prospective, single-arm, multicentric study with 50 MASLD patients with a mean age of 51.84 ± 10.66 years included 33 males. Patients received Saroglitazar magnesium 4 mg in addition to the standard of care for 6 months. The primary objective was to assess changes in liver stiffness measurement (LSM) and controlled attenuation parameter (CAP), and secondary objectives included evaluating changes in metabolic parameters such as fasting blood glucose (FBG), postprandial blood glucose (PPBG), HbA1c, triglyceride levels, and liver enzymes (ALT, alanine aminotransferase; AST, aspartate aminotransferase) at baseline and the end of the study.

Results: A statistically significant improvement in hepatic parameters, including LSM and CAP scores, was observed. Concurrently, at the end of the study duration, 16% of patients showed improvement from liver fibrosis stages of F3/F4 to F0/F1/F2 (p < 0.0001), and 76% of patients with severe steatosis (S3) decreased to 38% (p < 0.0001). The key metabolic parameters also showed statistically significant reduction in FBG from 140.25 ± 51.5 mg/dL to 117.66 ± 18.17 mg/dL (p = 0.004), HbA1c from 7.46% ± 1.44% to 6.83% ± 1.08% (p = 0.0004) and triglyceride levels from 238.67 ± 168.35 mg/dL to 167.9 ± 113.89 mg/dL (p = 0.0001). However, during the study, anthropometric parameters remained stable, with a minor increase in BMI (28.91 ± 3.5 to 29.12 ± 3.67 Kg/m²).

Conclusion: Despite a slight increase in BMI, Saroglitazar significantly improved transient elastography parameters and hepatic parameters in MASLD patients, suggesting that this drug alone effectively manages MASLD-related metabolic and hepatic dysfunctions.

Keywords: AST; MASLD; Saroglitazar; dyslipidemia.