蒂尔泽帕提德用于代谢功能障碍相关的肝硬性肝炎与肝纤维化
Rohit Loomba1, Mark L Hartman1, Eric J Lawitz1
1From the Metabolic Dysfunction-Associated Steatotic Liver Disease Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California at San Diego, La Jolla (R.L.), and Pacific Rim Pathology, San Diego (C.B.) - both in California; Eli Lilly (M.L.H., Y.T., B.B., D.A.R., A.N., M.C.B., A.H.), the Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine (R.V.), and the Department of Pathology and Laboratory Medicine, Indiana University (O.W.C.) - all in Indianapolis; the Texas Liver Institute, University of Texas Health, San Antonio (E.J.L.); the Department of Hepato-Gastroenterology and Digestive Oncology, Angers University Hospital, and Hemodynamics, Interaction of Fibrosis and Hepatic Tumor Invasiveness Laboratory, Structure Fédérative de Recherche Interactions Cellulaires et Applications Thérapeutiques 4208, Angers University - both in Angers, France (J.B.); the Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy (E.B.); the Department of Gastroenterology and Hepatology, Yokohama City University, Yokohama, Japan (M.Y.); and the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health and Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond (A.J.S.).
蒂尔泽帕提德在第二阶段试验中显著改善了与代谢功能障碍相关的脂肪肝炎 (MASH) 和肝纤维化. 需要进一步的研究来确认蒂尔泽帕蒂德的存在.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 代谢功能障碍相关的脂肪肝炎 (MASH) 是一种严重的肝病,具有显著的死亡风险.
- 针对中度至重度纤维化MASH的双重GIP/GLP-1受体激动剂蒂尔泽帕提德的疗效仍在研究中.
研究的目的:
- 评估在被诊断为MASH和F2或F3阶段肝纤维化患者中提尔泽帕提德的疗效和安全性.
- 为了确定MASH治疗的最佳蒂尔泽帕提德剂量.
主要方法:
- 一个52周,双盲,随机,安慰剂控制,多中心的第二阶段试验.
- 参与者每周接受皮下提尔泽帕提德 (5,10或15毫克) 或安慰剂.
- 主要终点:MASH解脱无纤维化恶化;次要终点:纤维化改善至少一个阶段.
主要成果:
- 与安慰剂相比,提尔泽帕提德在所有测试剂量 (44-62%与10%相比) 中显示出更高的MASH解决率.
- 在提尔泽帕提德组 (51-55%) 与安慰剂 (30%) 相比,观察到显著的纤维化改善.
- 胃肠道事件是最常见的不良事件,一般为轻度至中度.
结论:
- 在中度至重度肝纤维化患者中,为期52周的提尔泽帕蒂德治疗有效地消除MASH,而不会使纤维化恶化.
- 需要进行更大,更长期的研究,以充分确定tirzepatide在MASH治疗中的疗效和安全性.
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