Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial

Jun 4, 2025BMJ (Clinical research ed.)

Dapagliflozin's effects on fatty liver disease linked to metabolism in a controlled clinical trial

AI simplified

GLP-1 Therapies on OpenScience ↗PubMed ↗DOI ↗OA ↗

Abstract

improvement without worsening of fibrosis was observed in 53% of participants treated with dapagliflozin.

In the dapagliflozin group, 30% of participants showed MASH improvement without worsening of fibrosis compared to 53% in the dapagliflozin group.
A mean decrease of -1.39 in the non-alcoholic fatty liver disease activity score was documented for the dapagliflozin group.
MASH resolution without worsening of fibrosis occurred in 23% of participants receiving dapagliflozin versus 8% in the placebo group.
Fibrosis improvement without worsening of MASH was seen in 45% of the dapagliflozin group compared to 20% in the placebo group.
Adverse events led to treatment discontinuation in 1% of the dapagliflozin group and 3% of the placebo group.

AI simplified

OBJECTIVE: To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor dapagliflozin in participants with metabolic dysfunction-associated steatohepatitis ().

DESIGN: Multicentre, double blind, randomised, placebo controlled trial.

SETTING: Six tertiary hospitals in China from 23 November 2018 to 28 March 2023.

PARTICIPANTS: 154 adults with biopsy diagnosed MASH, with or without type 2 diabetes.

INTERVENTIONS: All participants were randomly assigned to receive 10 mg orally of dapagliflozin or matching placebo once daily for 48 weeks.

MAIN OUTCOME MEASURES: The primary endpoint was MASH improvement (defined as a decrease of at least 2 points in non-alcoholic fatty liver disease activity score (NAS) or a NAS of ≤3 points) without worsening of liver fibrosis (defined as without increase of fibrosis stage) at 48 weeks. The secondary endpoints included the MASH resolution without worsening of fibrosis and fibrosis improvement without worsening of MASH. Analyses used the intention-to-treat dataset.

RESULTS: MASH improvement without worsening of fibrosis was reported in 53% (41/78) of participants in the dapagliflozin group and 30% (23/76) in the placebo group (risk ratio 1.73 (95% confidence interval (CI) 1.16 to 2.58); P=0.006). Mean difference of NAS was -1.39 (95% CI -1.99 to -0.79); P<0.001). MASH resolution without worsening of fibrosis occurred in 23% (18/78) of participants in the dapagliflozin group and 8% (6/76) in the placebo group (risk ratio 2.91 (95% CI 1.22 to 6.97); P=0.01). Fibrosis improvement without worsening of MASH was reported in 45% (35/78) of participants in the dapagliflozin group, as compared with 20% (15/76) in the placebo group (risk ratio 2.25 (95% CI 1.35 to 3.75); P=0.001). The percentage of individuals who discontinued treatment because of adverse events was 1% (1/78) in the dapagliflozin group and 3% (2/76) in the placebo group.

CONCLUSION: Treatment with dapagliflozin resulted in a higher proportion of participants with MASH improvement without worsening of fibrosis, as well as MASH resolution without worsening of fibrosis and fibrosis improvement without worsening of MASH, than with placebo.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03723252.

Key numbers

53%

Increase in Improvement

53% of dapagliflozin group vs. 30% in placebo group

23%

Resolution Rate

23% in dapagliflozin group vs. 8% in placebo group

45%

Fibrosis Improvement Rate

45% in dapagliflozin group vs. 20% in placebo group

Full Text

We can’t show the full text here under this license. Use the link below to read it at the source.

View full text ↗

Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial

Abstract

Key numbers

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief

Abstract

Key numbers

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief