Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial
Authors' conclusion
Dapagliflozin was associated with significant improvements in hepatic steatosis, non-invasive fibrosis surrogate markers, metabolic parameters, and liver function in T2DM patients with MASLD over 12 months.
Study context
- Population
- Patients with T2D and MASLD50 completed, per-protocol
- Participants
- 54 patients
- Primary endpoint
- Changes in hepatic steatosis (CAP) and non-invasive fibrosis surrogates (LSM)
- Follow-up
- 12 months
Methodological detailsopen-label, parallel-group, per-protocol analysis
- Open-label
- Parallel-group
- Per-protocol analysis
Primary result
As reported in the abstract
- Hepatic steatosis (CAP): 316.7 to 245.7 dB/m; mean change - 71.02 dB/m (95% CI −63.4 to - 78.6; p < 0.001)
- Liver stiffness (LSM): 8.59 to 7.28 kPa; mean change - 1.31 kPa (95% CI −0.92 to - 1.70; p < 0.001)
- Per-protocol analysis
- Single-arm
Further findings
Glycaemic control, body weight, lipid profile, liver enzymes, US steatosis grading, serum fibrosis markers
- Improvements observed
Safety
- Genitourinary infections, the most frequently reported adverse events
- 32%
- Serious adverse events
- 0
Original publication
Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial. Diabetes Res Clin Pract. Published 25 August 2026. doi:10.
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