Survodutide针对代谢功能障碍相关脂肪性肝炎（MASH）代偿性肝硬化（4期）III期临床试验在中国入组首例患者

关于survodutide

Survodutide是一种胰高血糖素受体/胰高血糖素样肽-1受体（GCGR/GLP-1R）双重激动剂，可同时激活胰高血糖素受体和GLP-1受体，这对于控制代谢功能至关重要。Zealand Pharma授权勃林格殷格翰全权负责survodutide的全球开发与商业化，保留了在北欧市场的联合推广权益。Survodutide是勃林格殷格翰在代谢心肾疾病领域研发组合的组成部分。目前，survodutide用于MASH和纤维化治疗已成功获得美国食品药品监督管理局（FDA）与中国国家药品监督管理局（NMPA）“突破性疗法”认定，欧洲药品管理局（EMA）将其纳入优先药物（PRIME）计划。

关于LIVERAGE^™项目

LIVERAGE^™和LIVERAGE^™-Cirrhosis是两项针对代谢功能障碍相关脂肪性肝炎（MASH）的全球III期临床研究，旨在分别评估survodutide对MASH伴有肝纤维化2期或3期成人患者，以及代偿性MASH肝硬化（4期）成人患者的有效性和安全性。LIVERAGE^™项目拟在全球488个研究中心入组约1800名成人患者，其中包括从中国约57家临床试验中心计划入组159名患者。LIVERAGE^™-Cirrhosis临床试验项目拟在全球471个研究中心入组约1590名成人患者，其中包括从中国约50个临床试验中心计划入组138名患者。

参考文献

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[6] “Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease.” Boehringer Ingelheim. www.boehringer-ingelheim.com/phase-3-studies-survodutide-obesity-and-overweight. Accessed June 2024

[7] “A Study to Test Whether BI 456906 Helps Chinese People Living With Overweight or Obesity to Lose Weight.” Clinicaltrials.gov. clinicaltrials.gov/study/NCT06214741. Accessed June 2024

[8] “A Study to Test Whether BI 456906 Helps Japanese People Living With Obesity Disease (SYNCHRONIZEJP).” Clinicaltrials.gov. clinicaltrials.gov/study/NCT06176365. Accessed June 2024

[9] Quek, Jingxuan, et al. “Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population: a systematic review and meta-analysis.” The Lancet Gastroenterology & Hepatology. Vol. 8, no. 1, Jan. 2023, pp. 20-30. https://doi.org/10.1016/S2468-1253(22)00317-X

[10] “A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight”. Clinicaltrials.gov. https://clinicaltrials.gov/study/NCT06309992. Accessed June 2024.