Saroglitazar and vitamin E vs. lifestyle interventions in metabolic dysfunction associated steatotic liver disease: A 3-arm randomised study.

Background and objectives Lifestyle interventions are a vital component for the management of metabolic dysfunction-associated steatotic liver disease (MASLD). In the present study, we investigated the differential effect of saroglitazar or vitamin E vs. lifestyle interventions only. Methods A total 150 non-diabetic patients aged 19-55 yr were recruited to receive saroglitazar and vitamin E along with lifestyle interventions and lifestyle interventions alone (n=50 in each arm, A, B and C, respectively) for 24 weeks. Liver stiffness measurements and NAFLD fibrosis score were the primary outcomes. The study was registered under Trial registration (CTRI/2022/05/042462). Results Per-protocol analysis was performed in 136 patients (n=46, 47, and 43 in arms A, B and C, respectively). The changes from baseline were not-significant for NAFLD fibrosis score [0.05±0.52, 0.06±0.64 and -0.12±1.0, 95% confidence interval (CI), P =0.41] and liver stiffness measurement [-1.25 (-2.6, -0.2), -1.4 (-3.7, 0.4,) and -0.7 (-1.8, -0.2), P =0.22] in either arm. Changes in secondary outcomes were also not-significant except triglyceride [-13.95 (-61, -18), -4.3 (-28.8, 49) and -13 (-127, 3) P=0.035]. A considerable proportion of patients had at least '2 Kpa reduction' in liver stiffness measurement in arm A (39%) compared to C (19%). Interpretation and conclusions Saroglitazar or vitamin E are similar to lifestyle interventions in improving different non-invasive parameters in MASLD at 24 weeks of intervention.