Study wrapper · #1230
Efficacy of Luseogliflozin Added to Semaglutide in Patients With Metabolic Dysfunction-Associated Steatohepatitis and Type 2 Diabetes Mellitus: A Randomised, Open-Label Trial.
Editor's note
A negative trial on its primary analysis, and worth reporting as such: with 60 participants and an open-label design, it was underpowered to resolve histological differences of the size observed. The consistent direction across all three histology endpoints plus the biomarker improvements makes this a reasonable signal for a larger study rather than a null result. Note also that semaglutide was dosed at antidiabetic rather than obesity-trial levels, which limits comparison with the MASH-specific programme.
Plain-language abstract
In this 52-week Japanese randomized open-label trial, 60 adults with biopsy-confirmed MASH and type 2 diabetes received either semaglutide plus the SGLT2 inhibitor luseogliflozin or semaglutide alone, with liver biopsies before and after. Every liver-histology endpoint numerically favoured the combination, but in the main pre-specified analysis none reached statistical significance. The combination did produce greater reductions in body weight, HbA1c, liver enzymes, and FibroScan liver stiffness, with no new safety concerns.