DOI: 10.1002/edm2.70377 ISSN: 2398-9238
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
Mukulesh Gupta, Kumar Prafull Chandra, Rajiv Awasthi, Arunkumar R. Pande, Nitin Ranjan Gupta, Vivek Agarwal, Dinesh Kumar 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