Introduction and Objective: Metabolic Associated Steatotic Liver Disease (MASLD) frequently coexists with type 2 diabetes mellitus (T2DM) and obesity and represents a major unmet clinical need, particularly with respect to therapies that improve both hepatic and metabolic outcomes. Comparative data between saroglitazar (SARO) and dapagliflozin (DAPA) in MASLD are limited.Methods: A 24-week, prospective, multicenter, open-label, active-controlled study (CTRI/2024/08/071848) enrolled adults aged 18-70 years with FibroScan®-confirmed MASLD (controlled attenuation parameter [CAP] ≥300 dB/m and liver stiffness measurement [LSM] ≥8 kPa). Participants received SARO 4 mg once daily (n=27) or DAPA 10 mg once daily (n=27), in addition to standard of care. Primary endpoints were the change from baseline in hepatic steatosis (CAP) and fibrosis (LSM). Secondary endpoints included changes in glycemic parameters, lipid profile, liver enzymes, anthropometric measures, and safety.Results: Both treatments resulted in significant reductions in hepatic steatosis at week 24 (SARO: 314.7→278.7 dB/m; DAPA: 310.2→287.0 dB/m), with no significant between-group difference (p=0.44). Changes in LSM were minimal and comparable between groups (SARO: 8.4→8.0 kPa; DAPA: 8.3→7.9 kPa; p=0.80). Improvements in glycemic control were observed with both agents; however, HbA1c reduction was significantly greater with SARO compared with DAPA (−1.52% vs −0.84%; p=0.04). Triglyceride reduction was more pronounced in the SARO group, while liver enzymes improved in both arms. No treatment-emergent adverse events were reported.Conclusion: In adults with MASLD, SARO and DAPA produced comparable short-term improvements in hepatic steatosis but had no significant effects on fibrosis over 24 weeks. SARO was associated with greater improvements in glycemic control and triglyceride levels, highlighting potential differences by metabolic phenotype, supporting individualized treatment selection in MASLD, which warrants longer-term outcome studies.
D. Kumar: None. H. Lachhwani: None. M. Gupta: None. K. Chandra: Speaker’s Bureau; Current; Eli Lilly and Company, Novo Nordisk, Sanofi, Boehringer Ingelheim International GmbH, Abbott, Cipla Inc. Advisory Panel; Current; Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., USV Private Limited. R. Awasthi: Speaker’s Bureau; Current; Eli Lilly and Company, Boehringer Ingelheim International GmbH, Sanofi, Novo Nordisk, Bayer AG, Cipla Inc., Sun Pharmaceutical Industries Ltd., Servier Laboratories, USV Private Limited. T. Gupta: None. S. Awasthi: None. A.R. Pande: Speaker’s Bureau; Current; Eli Lilly and Company, Novo Nordisk, Bayer AG. Advisory Panel; Current; Lupin Pharmaceuticals, Inc. Speaker’s Bureau; Current; Sanofi, Serdia Pharmaceuticals (India) Pvt. Ltd. Advisory Panel; Current; Sun Pharmaceutical Industries Ltd. Speaker’s Bureau; Current; USV Private Limited, Cipla Inc., Boehringer Ingelheim International GmbH. N.R. Gupta: Speaker’s Bureau; Current; Novo Nordisk. Advisory Panel; Current; Lupin Pharmaceuticals, Inc. Speaker’s Bureau; Current; Eli Lilly and Company, USV Private Limited. Advisory Panel; Current; Sun Pharmaceutical Industries Ltd. Speaker’s Bureau; Current; Cipla Inc. V. Agarwal: Speaker’s Bureau; Current; Novo Nordisk, Cipla Inc. Advisory Panel; Current; Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., USV Private Limited. Speaker’s Bureau; Current; Boehringer Ingelheim International GmbH. Advisory Panel; Current; Eris Lifesciences Ltd. Speaker’s Bureau; Current; Bayer AG. Advisory Panel; Current; Glenmark Pharmaceuticals.
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