9月18日，勃林格殷格翰中国向国家药品监督管理局药品审评中心(CDE, NMPA)成功递交针对中国超重或肥胖人群的多中心临床试验申请。该试验旨在进一步探索survodutide(GCGR/GLP-1R双重激动剂)在中国患者中的疗效和安全性。此前公布的全球多中心II期临床研究数据表明，在为期46周的survodutide治疗期后，患者体重减轻可高达19%[1]。

　　根据世界卫生组织的统计标准，截至2016年，全球超过19亿成年人体重超重(BMI≥25 kg/m2)[2]，其中超过6.5亿人患有肥胖(BMI≥30 kg/m2)[3]。肥胖是指可能损害健康的异常或过多身体脂肪蓄积, 属于慢性、易复发、进行性疾病状态，目前已成为国际和国内都十分重视的公共卫生问题。

　　不同于世卫组织的定义，中国肥胖问题工作组基于中国患者的特点，建议设定BMI值24.0kg/m2为超重临界值，28.0 kg/m2为肥胖临界值。《中国居民营养与慢性病状况报告(2020年)》显示，成人(≥18岁)的超重率为34.3%、肥胖率为16.4%，超重/肥胖成年人已过半。按照绝对人口数来计算，我国目前已有6亿人超重和肥胖，显然这个数字在全球排名第一。超重和肥胖是复杂的慢性疾病，涉及脂肪的异常或过度蓄积，对个人整体健康构成威胁。[4]

　　勃林格殷格翰大中华区研发和医学高级副总裁张维博士表示，"代谢和心血管、肾病疾病是勃林格殷格翰深耕的疾病领域之一，我们深知该领域中存在巨大未被满足的临床需求。目前中国临床研发团队正积极准备参与全球多中心III期临床试验的前期工作。与此同时，我们也期待该中国临床试验申请能够早日获批，产生survodutide专门针对中国超重和肥胖患者的有效性和安全性的循证医学证据。"

　　参考资料

　　[1] Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906). Available at https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/obesity/phase-ii-clinical-trial-weight-loss-results.

　　[2] World Health Organization. Obesity and Overweight. Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Accessed June 2023.

　　[3] World Heart Federation. Obesity. 2015. Available at: https://world-heart-federation.org/what-we-do/obesity/#:~:text=Global%20estimates%20suggest%20that%20almost,overweight%20or%20obesity%20by%202025 . Accessed June 2023.

　　[4] Bray GA et al. Obesity: A chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev 2017;18:715–723.

　　[5] T. Zimmerman et al. BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy. Molecular Metabolism. 2022;66:101633.

　　[6] ClinicalTrials.gov: A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3). Available at https://clinicaltrials.gov/ct2/show/NCT04771273https://clinicaltrials.gov/ct2/show/NCT04771273 Accessed June 2023.

　　[7] Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH. https://www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-and-zealand-pharma-receive-fda-fast-track-designation. Accessed June 2023.