Efficacy of Luseogliflozin Added to Semaglutide in Patients With Metabolic Dysfunction‐Associated Steatohepatitis and Type 2 Diabetes Mellitus: A Randomised, Open‐Label Trial
Authors' conclusion
In the pre-specified full analysis set, combination therapy at antidiabetic doses did not significantly improve pre-specified histological endpoints compared with monotherapy. In the pre-specified per-protocol analysis, a nominal improvement in the NAS was observed. Combination therapy improved body weight, glycemic control, aminotransferase levels and liver stiffness, with no new safety concerns identified.
Study context
- Population
- Adults with biopsy-confirmed MASH and T2D, Japanrandomised
- Participants
- 60 adults
- Comparison
- Semaglutide plus luseogliflozin vs semaglutide alone
- Combinationn = 24
- Monotherapyn = 36reference
- Primary endpoint
- Histological endpoints: resolution of MASH without worsening fibrosis; ≥ 1-point improvement in NAS without worsening fibrosis; ≥ 1-stage improvement in fibrosis without worsening MASH
- Follow-up
- Week 52
Methodological details52-week, open-label, parallel-group, blinded pathologists
- 52-week
- Open-label
- Parallel-group
- Blinded pathologists
Primary result
As reported in the abstract
Resolution of MASH without worsening fibrosis: Combination vs Monotherapy
34.9% vs 19.4%
≥ 1-point improvement in NAFLD activity score (NAS): Combination vs Monotherapy
75.5% vs 55.6%
≥ 1-stage fibrosis improvement: Combination vs Monotherapy
26.9% vs 13.9%
Further findings
≥ 1-point improvement in NAS, per-protocol analysis · Week 52
- Nominally significant in the pre-specified per-protocol analysis
Body weight, HbA1c, aminotransferases, FibroScan liver stiffness
- Combination therapy reduced body weight, HbA1c, aminotransferase levels and liver stiffness
Original publication
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