A common diabetes medication may soon become a game-changer in treating a dangerous and hard-to-treat liver disease.
Key Points at a Glance
- Dapagliflozin significantly improved MASH—a serious liver disease—without worsening fibrosis in 53% of patients.
- Patients on dapagliflozin were 2.9 times more likely to experience full disease resolution than those on placebo.
- The drug also improved liver fibrosis, insulin resistance, and visceral fat, showing broad metabolic benefits.
- Adverse events were rare and similar between treatment and placebo groups, affirming the drug’s safety.
Scientists have just unlocked a powerful new use for an existing medication. In a major international trial, the diabetes drug dapagliflozin showed remarkable effectiveness in treating metabolic dysfunction-associated steatohepatitis (MASH)—a progressive, potentially fatal liver condition affecting millions worldwide.
The trial, conducted across six hospitals in China and published in The BMJ, enrolled 154 adults with biopsy-confirmed MASH. Participants were randomized to receive either dapagliflozin or a placebo daily for 48 weeks. The results were nothing short of transformative: more than half of the patients treated with dapagliflozin showed substantial improvement in liver inflammation and fat accumulation, without worsening fibrosis—the scarring that marks irreversible liver damage.
“This is the first time a trial of this size and quality has demonstrated such clear histological improvements in non-diabetic and diabetic MASH patients,” said lead investigator Dr. Huijie Zhang. The trial found that 53% of those taking dapagliflozin met the primary endpoint—MASH improvement without fibrosis worsening—compared to just 30% in the placebo group.
Equally important, 23% of patients on dapagliflozin achieved full resolution of MASH without fibrosis progression—nearly three times more than the placebo group. Meanwhile, liver fibrosis improvement without MASH worsening was observed in 45% of dapagliflozin users, versus 20% of those on placebo.
Dapagliflozin’s benefits extended beyond the liver. Participants experienced reductions in body weight, abdominal visceral fat, liver stiffness, and levels of liver enzymes like γ-GT. Blood sugar control improved among diabetics, and insulin resistance dropped in non-diabetics. These changes suggest that dapagliflozin’s effects are systemic, not just localized to liver cells.
Crucially, the treatment was also safe. Only 1% of dapagliflozin participants discontinued due to adverse events, compared to 3% on placebo. No serious cardiovascular events, cancer cases, or deaths occurred in the dapagliflozin group.
MASH, formerly known as NASH, is more aggressive than non-alcoholic fatty liver disease (MASLD) and can progress to cirrhosis in up to 25% of patients. Current treatment options are limited, with only one drug—resmetirom—approved for MASH in the U.S. in 2024. Dapagliflozin’s success offers a new, readily available option, especially for patients already managing type 2 diabetes.
The study’s findings may rapidly shift treatment guidelines and improve outcomes for millions. “We’re witnessing a potential paradigm shift,” said Dr. Zhang. “With its safety profile and systemic benefits, dapagliflozin could become a cornerstone of MASH therapy.”
Source: BMJ
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