Comparative Efficacy and Safety of Saroglitazar and Dapagliflozin on Hepatic Steatosis and Glycemic Control in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A 25-Week Prospective Multicenter Comparative Cohort Study.
7 affiliations
- 1Udyan Health Care Pvt Ltd, Lucknow, Uttar Pradesh, India.
- 2Dr Chandra's Diabetes and Heart Clinic, Lucknow, Uttar Pradesh, India.
- 3Prarthana Clinic and Diabetes Care Centre, Lucknow, Uttar Pradesh, India.
- 4Lucknow Endocrine Diabetes & Thyroid Clinic, Lucknow, Uttar Pradesh, India.
- 5Lucknow Hormone Centre, Lucknow, Uttar Pradesh, India.
- 6RR Diabetes and Heart Care Centre, Lucknow, Uttar Pradesh, India.
- 7Harsha Clinic and Diabetes Centre, Lucknow, Uttar Pradesh, India.
Abstract
Introduction
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the leading cause of chronic liver disease globally, driven by rising obesity and type 2 diabetes mellitus (T2DM). Existing medications provide minimal fibrosis regression, highlighting the need for comparative evidence on agents with metabolic and hepatic benefits. This study compared the efficacy and safety of saroglitazar 4 mg and dapagliflozin 10 mg in patients with MASLD.Methods
This 25-week, prospective, multicentre, open-label active-controlled comparative cohort study enrolled adults aged 18-70 years with MASLD confirmed by FibroScan (steatosis grade S3, controlled attenuation parameter [CAP] ≥ 292 dB/m, and/or fibrosis stage ≥F2, liver stiffness measurement [LSM] ≥ 8.0 kPa). Participants received saroglitazar (n = 27) or dapagliflozin (n = 27) once daily, added to standard of care per physician discretion. The primary endpoint was change from baseline in hepatic steatosis (CAP) and fibrosis (LSM); secondary endpoints included HbA1c, hepatic enzymes, lipid profile, and adverse events.Results
All 54 participants completed follow-up. CAP decreased from 314.7 to 278.7 dB/m with saroglitazar and from 310.2 to 287.0 dB/m with dapagliflozin (between-group p = 0.44). LSM decreased in both arms (saroglitazar -0.96 kPa; dapagliflozin -0.46 kPa; between-group p = 0.80). HbA1c improved in both groups (saroglitazar 8.28%-6.76%; dapagliflozin 8.14%-7.30%), with a significantly greater reduction with saroglitazar (between-group p = 0.04). ALT and AST declined similarly in both arms despite higher baseline ALT with saroglitazar. Triglycerides decreased significantly within both groups (saroglitazar -62.5 mg/dL; dapagliflozin -28.3 mg/dL), with no significant between-group difference. No treatment-emergent adverse events, including edema, occurred in either group.Conclusions
Both saroglitazar and dapagliflozin improved hepatic steatosis, fibrosis markers, liver enzymes, and glycemic control over 25 weeks, with comparable hepatic benefit. Saroglitazar produced a significantly greater reduction in HbA1c, suggesting a possible glycemic-preferential advantage in patients requiring simultaneous glycemic and hepatic control; larger randomized trials are needed to confirm any differential hepatic efficacy.Trial registration
Clinical Trials Registry of India, CTRI/2024/08/071848.
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BibTeX
@article{gupta2026comparative,
title = {{Comparative Efficacy and Safety of Saroglitazar and Dapagliflozin on Hepatic Steatosis and Glycemic Control in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A 25-Week Prospective Multicenter Comparative Cohort Study.}},
author = {Mukulesh Gupta and Kumar Prafull Chandra and Rajiv Awasthi and Arunkumar R Pande and Nitin Ranjan Gupta and Vivek Agarwal and Dinesh Kumar},
journal = {Endocrinology, diabetes \& metabolism},
year = {2026},
month = nov,
doi = {10.1002/edm2.70377},
url = {https://europepmc.org/article/MED/42967591},
note = {CC BY},
}
RIS
TY - JOUR
TI - Comparative Efficacy and Safety of Saroglitazar and Dapagliflozin on Hepatic Steatosis and Glycemic Control in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A 25-Week Prospective Multicenter Comparative Cohort Study.
AU - Mukulesh Gupta
AU - Kumar Prafull Chandra
AU - Rajiv Awasthi
AU - Arunkumar R Pande
AU - Nitin Ranjan Gupta
AU - Vivek Agarwal
AU - Dinesh Kumar
PY - 2026
DA - 2026/11/01
JO - Endocrinology, diabetes & metabolism
DO - 10.1002/edm2.70377
UR - https://europepmc.org/article/MED/42967591
AB - Introduction Metabolic dysfunction-associated steatotic liver disease (MASLD) is the leading cause of chronic liver disease globally, driven by rising obesity and type 2 diabetes mellitus (T2DM). Existing medications provide minimal fibrosis regression, highlighting the need for comparative evidence on agents with metabolic and hepatic benefits. This study compared the efficacy and safety of saroglitazar 4 mg and dapagliflozin 10 mg in patients with MASLD.Methods This 25-week, prospective, multicentre, open-label active-controlled comparative cohort study enrolled adults aged 18-70 years with MASLD confirmed by FibroScan (steatosis grade S3, controlled attenuation parameter [CAP] ≥ 292 dB/m, and/or fibrosis stage ≥F2, liver stiffness measurement [LSM] ≥ 8.0 kPa). Participants received saroglitazar (n = 27) or dapagliflozin (n = 27) once daily, added to standard of care per physician discretion. The primary endpoint was change from baseline in hepatic steatosis (CAP) and fibrosis (LSM); secondary endpoints included HbA1c, hepatic enzymes, lipid profile, and adverse events.Results All 54 participants completed follow-up. CAP decreased from 314.7 to 278.7 dB/m with saroglitazar and from 310.2 to 287.0 dB/m with dapagliflozin (between-group p = 0.44). LSM decreased in both arms (saroglitazar -0.96 kPa; dapagliflozin -0.46 kPa; between-group p = 0.80). HbA1c improved in both groups (saroglitazar 8.28%-6.76%; dapagliflozin 8.14%-7.30%), with a significantly greater reduction with saroglitazar (between-group p = 0.04). ALT and AST declined similarly in both arms despite higher baseline ALT with saroglitazar. Triglycerides decreased significantly within both groups (saroglitazar -62.5 mg/dL; dapagliflozin -28.3 mg/dL), with no significant between-group difference. No treatment-emergent adverse events, including edema, occurred in either group.Conclusions Both saroglitazar and dapagliflozin improved hepatic steatosis, fibrosis markers, liver enzymes, and glycemic control over 25 weeks, with comparable hepatic benefit. Saroglitazar produced a significantly greater reduction in HbA1c, suggesting a possible glycemic-preferential advantage in patients requiring simultaneous glycemic and hepatic control; larger randomized trials are needed to confirm any differential hepatic efficacy.Trial registration Clinical Trials Registry of India, CTRI/2024/08/071848.
SN - 2398-9238
ER -