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研究简介<\/b><\/p> \n

一项在不伴有2型糖尿病的超重或肥胖受试者中比较皮下给药46周、每周一次Survodutide和安慰剂对照的随机、平行分组、剂量探索的II期研究。[1]<\/span><\/sup>试验包括20周的剂量递增期和26周的剂量维持期,评估给药剂量分别为0.6 mg、2.4 mg、3.6 mg和4.8 mg的疗效。[1]<\/span><\/sup><\/p> \n

Survodutide<\/b>(<\/b>BI 456906<\/b>)简介<\/b><\/p> \n

Survodutide是一种胰高血糖素\/GLP-1受体双重激动剂,可同时激活GLP-1和胰高血糖素受体。这两种受体在新陈代谢功能调控中起着至关重要的作用。[2]<\/span><\/sup>Survodutide由勃林格殷格翰和Zealand Pharma共同开发,是勃林格殷格翰在心-肾-代谢疾病领域研发产品组合的一部分。<\/p> \n

我们同时也在非酒精性脂肪性肝炎(NASH)和肝纤维化(F1\/F2\/F3期)成人患者中开展II期研究,评估Survodutide的疗效。[3]<\/span><\/sup>试验预计在2023年第4季度完成。Survodutide已获得美国FDA针对其成人NASH适应症的快速通道资格认定。[4]<\/span><\/sup><\/p> \n

超重和肥胖简介<\/b><\/p> \n

2016年,全球超过19亿成年人体重超重,超重定义为体重指数(BMI)达到25或更高。[5]<\/span><\/sup>其中超过6.5亿人患有肥胖,肥胖定义为BMI达到30或更高。[6]<\/span><\/sup>世界肥胖联盟预测,2025年全球超重或肥胖人数可能达到27亿,将成为全球性健康难题,给个人、医疗保健系统和社会将带来沉重的负担。[6]<\/span><\/sup>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。[7]<\/span><\/sup><\/p> \n

关于勃林格殷格翰<\/b><\/p> \n

勃林格殷格翰致力于研究突破性疗法,旨在变革生命,守护世世代代的健康。作为一家研发驱动的全球领先生物制药企业,公司在医疗需求高度未得到满足的领域通过创新展现价值。勃林格殷格翰自1885年成立以来一直是一家独立的家族企业,始终着眼长远与可持续发展。在人用药品、动物保健两大业务领域,全球有超过5.3万名员工服务逾130个地区。更多详情,请访问:www.boehringer-ingelheim.com<\/p> \n

关于<\/b>Zealand Pharma A\/S<\/b><\/p> \n

Zealand Pharma A\/S(纳斯达克股票代码:ZEAL)(简称"Zealand")是一家专注于发现和开发肽类药物的生物技术公司。Zealand发明的10余种候选药物已进入临床开发,其中2种已上市,3种处于后期开发阶段。该公司与多家制药公司建立了开发合作伙伴关系,并为其上市产品建立了商业合作伙伴关系。<\/p> \n

Zealand 成立于 1998 年,总部位于丹麦哥本哈根,在包括波士顿在内的美国设有办事处。有关 Zealand 业务和活动的更多信息,请访问 www.zealandpharma.com<\/a><\/p> \n

参考文献<\/b><\/p> \n

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1 le Roux CW et al. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of BI 456906 in People with Overweight\/Obesity. Presented at the American Diabetes Association's 83rd<\/sup> Scientific Sessions 2023; 23 June 2023. 51-OR.<\/span><\/p>

2 T. Zimmerman et al.<\/i> BI 456906: Discovery and preclinical pharmacology of a novel GCGR\/GLP-1R dual agonist with robust anti-obesity efficacy. Molecular Metabolism. 2022;66:101633.<\/span><\/p>

3 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\/NCT04771273<\/a>. Accessed June 2023.<\/span><\/p>

4 Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH. Available at https:\/\/www.boehringer-ingelheim.com\/us\/press-release\/boehringer-ingelheim-and-zealand-pharma-receive-fda-fast-track-designation<\/a>.Accessed June 2023.<\/span><\/p>

5 World Health Organization. Obesity and Overweight. Available at https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/obesity-and-overweight<\/a>. Accessed June 2023.<\/span><\/p>

6 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.<\/span><\/p>

7 Bray GA et al.<\/i> Obesity: A chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev<\/i> 2017;18:715–723.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n

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