Trial reportThe Indian journal of medical research2026
Saroglitazar and vitamin E vs. lifestyle interventions in metabolic dysfunction associated steatotic liver disease: A 3-arm randomised study.
Trial report in The Indian journal of medical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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.
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