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　　9月18日，勃林格殷格翰中國向國家藥品監(jiān)督管理局藥品審評中心(CDE, NMPA)成功遞交針對中國超重或肥胖人群的多中心臨床試驗申請。該試驗旨在進一步探索survodutide(GCGR/GLP-1R雙重激動劑)在中國患者中的療效和安全性。此前公布的全球多中心II期臨床研究數(shù)據(jù)表明，在為期46周的survodutide治療期后，患者體重減輕可高達19%[1]。

　　根據(jù)世界衛(wèi)生組織的統(tǒng)計標準，截至2016年，全球超過19億成年人體重超重(BMI≥25 kg/m2)[2]，其中超過6.5億人患有肥胖(BMI≥30 kg/m2)[3]。肥胖是指可能損害健康的異常或過多身體脂肪蓄積, 屬于慢性、易復發(fā)、進行性疾病狀態(tài)，目前已成為國際和國內都十分重視的公共衛(wèi)生問題。

　　不同于世衛(wèi)組織的定義，中國肥胖問題工作組基于中國患者的特點，建議設定BMI值24.0kg/m2為超重臨界值，28.0 kg/m2為肥胖臨界值�！吨袊�居民營養(yǎng)與慢性病狀況報告(2020年)》顯示，成人(≥18歲)的超重率為34.3%、肥胖率為16.4%，超重/肥胖成年人已過半。按照絕對人口數(shù)來計算，我國目前已有6億人超重和肥胖，顯然這個數(shù)字在全球排名第一。超重和肥胖是復雜的慢性疾病，涉及脂肪的異�；蜻^度蓄積，對個人整體健康構成威脅。[4]

　　勃林格殷格翰大中華區(qū)研發(fā)和醫(yī)學高級副總裁張維博士表示，"代謝和心血管、腎病疾病是勃林格殷格翰深耕的疾病領域之一，我們深知該領域中存在巨大未被滿足的臨床需求。目前中國臨床研發(fā)團隊正積極準備參與全球多中心III期臨床試驗的前期工作。與此同時，我們也期待該中國臨床試驗申請能夠早日獲批，產(chǎn)生survodutide專門針對中國超重和肥胖患者的有效性和安全性的循證醫(yī)學證據(jù)。"

　　參考資料

　　[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.