Diabetes drug shows benefits for patients with liver disease

The sodium glucose cotransporter 2 (SGLT-2) inhibitor drug dapagliflozin, widely used to treat type 2 diabetes, also shows improvements for patients with progressive liver disease, a clinical trial from China has found.

Published by The BMJ, the results show that treatment with dapagliflozin improved metabolic dysfunction-associated steatohepatitis (MASH) – a condition where excess fat accumulates in the liver, leading to inflammation – and liver fibrosis (a build-up of scar tissue) compared with placebo.

MASH affects more than 5% of adults, more than 30% of people with diabetes or obesity, and can progress to cirrhosis in up to 25% of individuals.

Several studies have reported that SGLT-2 inhibitors can improve liver fat content, liver enzymes, and liver stiffness, but until now no trial has been carried out among patients with MASH.

After an end of study biopsy, 53% (41 of 78) participants in the dapagliflozin group showed improvement in MASH without worsening of fibrosis (defined as no increase in fibrosis stage) compared with 30% (23 of 76) in the placebo group.

Resolution of MASH without worsening of fibrosis occurred in 23% (18 of 78) participants in the dapagliflozin group compared with 8% (6 of 76) in the placebo group.

Fibrosis improvement without worsening of MASH was also reported in 45% (35 of 78) participants in the dapagliflozin group compared with 20% (15 of 76) in the placebo group.

The percentage of participants who discontinued treatment because of adverse events was 1% (1 of 78) in the dapagliflozin group and 3% (2 of 76) in the placebo group.

The researchers acknowledge that the trial was conducted in a Chinese population, which limits its broader generalisability, and that female and older patients were under-represented. But they point out that results were consistent after further analyses, suggesting they are robust.

As such, they conclude: ‘Our findings indicate that dapagliflozin may affect key aspects of MASH by improving both steatohepatitis and fibrosis.’ Large scale and long term trials are needed to further confirm these effects, they add.

The coming years are expected to be particularly exciting in the field of pharmacological treatment for MASH, a linked editorial states, and therapies are likely become increasingly tailored to individual patient profiles: ‘Ideally, such treatments should provide cardiovascular benefit, have an established safety profile, and be accessible to broad and diverse patient populations.’

Lin J, et al. BMJ 2025;389:e083735