Effects of imeglimin on liver enzymes and body composition in patients with MASLD and type 2 diabetes: a pilot study

Abstract

Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in patients with type 2 diabetes mellitus (T2DM), yet effective pharmacological options remain limited. Imeglimin, a novel antidiabetic agent targeting mitochondrial bioenergetics, has shown potential hepatoprotective effects in preclinical studies; however, its impact on liver function and body composition in MASLD remains unclear. This retrospective, single-center pilot study analyzed prospectively collected data from 28 patients with MASLD and T2DM who were treated with imeglimin for 6 months. Clinical and biochemical parameters were assessed at baseline and at 3 and 6 months. Body composition was evaluated using bioelectrical impedance analysis. Over 6 months, fasting blood glucose decreased from 148.5 to 131.0 mg/dL (p = 0.015), accompanied by reductions in liver enzymes (aspartate aminotransferase: 33–26 U/L, p < 0.001; alanine aminotransferase: 28.5–23.5 U/L, p = 0.001). Body weight and body fat percentage also decreased (p < 0.001 and p = 0.018, respectively), whereas no statistically significant changes were observed in skeletal muscle mass. No serious adverse events were reported. Imeglimin therapy was associated with favorable changes in glycemic parameters, liver enzymes, and body composition in this pilot cohort, without a statistically significant reduction in skeletal muscle mass. These findings suggest a potential metabolic and hepatic effect of imeglimin and may be particularly relevant for patients with MASLD at risk of sarcopenia. Larger prospective studies with histological or validated non-invasive endpoints are warranted.