Summary: In 154 adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH), 48 weeks of dapagliflozin 10 mg daily improved histological MASH without worsening fibrosis in 53% of patients versus 30% on placebo (RR 1.73, 95% CI 1.16 to 2.58; P=0.006). MASH resolution and fibrosis improvement also favoured dapagliflozin, with few treatment discontinuations.
PICO Summary
| Element | Detail |
|---|---|
| Population | 154 adults with biopsy-diagnosed MASH, with or without type 2 diabetes; multicentre double-blind RCT across six tertiary hospitals in China (2018 to 2023). |
| Intervention | Dapagliflozin 10 mg orally once daily for 48 weeks (n=78). |
| Comparison | Matching placebo once daily for 48 weeks (n=76). |
| Outcome | Primary: MASH improvement without worsening fibrosis 53% (41/78) vs 30% (23/76); RR 1.73 (95% CI 1.16 to 2.58), P=0.006; absolute difference about 23 percentage points (NNT about 4). Mean NAS difference -1.39 (95% CI -1.99 to -0.79), P<0.001. Secondary: MASH resolution without worsening fibrosis 23% (18/78) vs 8% (6/76); RR 2.91 (95% CI 1.22 to 6.97), P=0.01. Fibrosis improvement without worsening MASH 45% (35/78) vs 20% (15/76); RR 2.25 (95% CI 1.35 to 3.75), P=0.001. Discontinuation for adverse events 1% (1/78) vs 3% (2/76). |
Dapagliflozin for MASH
RCT · biopsy-confirmed MASH · 48 weeks
Dapagliflozin 10 mg for 48 weeks improved biopsy-confirmed MASH without worsening fibrosis in more patients than placebo (53% vs 30%, NNT about 4). Modest single-country trial; durability and hard outcomes unknown.
Expert Commentary
This is a positive, adequately blinded, placebo-controlled trial with biopsy-based histological endpoints, which makes it more credible than studies relying on imaging or biomarkers alone. The primary endpoint was met with a clinically meaningful absolute gain of roughly 23 percentage points, an estimated number needed to treat near four, and secondary endpoints for MASH resolution and fibrosis improvement that moved consistently in the same direction. The mean reduction in activity score was significant and supports a genuine histological signal rather than a chance result. Several caveats temper enthusiasm. The trial was modest in size at 154 participants and conducted entirely in tertiary centres in China, so generalisability to other populations and to primary care is uncertain, and the wide confidence interval around the resolution estimate reflects few events. Forty-eight weeks tells us nothing about durability or hard liver outcomes. Can I use this with my patients? Cautiously yes for a patient with type 2 diabetes and biopsy-confirmed MASH who already has another reason for an SGLT2 inhibitor, where this adds supportive rationale rather than a standalone indication. For non-diabetic MASH it remains investigational. Larger, longer, more diverse trials with clinical endpoints are needed before dapagliflozin can be recommended specifically to treat MASH.
References
Lin J, Huang Y, Xu B, et al. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025;389:e083735. doi:10.1136/bmj-2024-083735