蒂尔泽帕提德用于与代谢功能障碍相关的脂肪肝炎:二期临床试验的结果和前景
Stefano Fiorucci1, Ginevra Urbani1
1Department of Medicine and Surgery, Section of Gastroenterology, University of Perugia, Perugia, Italy.
Expert opinion on investigational drugs
|August 9, 2025
概括
双重GIP/GLP-1受体激动剂蒂尔泽帕提德在2期试验中显示出有望解决MASH (代谢功能障碍相关的脂肪肝炎),而不会使纤维化恶化. 需要进一步的研究来证实MASH治疗中的这些发现.
科学领域:
- 肝病学和内分泌学.
- 英克雷丁模仿剂的药理学
背景情况:
- 蒂尔泽帕提德是一种可注射的双双依赖葡萄糖的胰岛素型多 (GIP) 和类似葡萄糖-1 (GLP-1) 受体激动剂.
- 蒂尔泽帕提德已批准用于超重/肥胖的成年人治疗2型糖尿病.
- GIP和GLP-1缩剂增强胰岛素的释放,并改善葡萄糖代谢.
研究的目的:
- 评估蒂尔泽帕提德在实现MASH解脱和纤维化改善方面的疗效.
- 评估蒂尔泽帕提德对肝硬化和纤维化在活检证明MASH的患者的影响.
主要方法:
- 第二阶段的SYNERGY-NASH研究涉及生检证明MASH和第二或第三阶段纤维化患者.
- 提尔泽帕提德治疗与安慰剂的比较.
主要成果:
- 与安慰剂相比,在 Tirzepatide 治疗的患者中,显著更高的百分比实现了 MASH 解决,而不会使纤维化恶化.
- 更多的tirzepatide组患者表现出1阶段或更大的纤维化改善,而没有MASH恶化,尽管没有统计数据支持.
- 非侵入性纤维化生物标志物没有显著改善.
结论:
- 蒂尔泽帕提德显示出作为MASH治疗的潜力,通过改善MASH分辨率和纤维化而表明.
- 药物提高胰岛素敏感性和减少食物摄入的能力可能有助于其对肝硬化和纤维化的有益作用.
- 需要进行更大规模的临床试验来验证这些发现,并确定蒂尔泽帕提德在MASH管理中的作用.
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