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研究簡介<\/b><\/p> \n

一項在不伴有2型糖尿病的超重或肥胖受試者中比較皮下給藥46周、每周一次Survodutide和安慰劑對照的隨機、平行分組、劑量探索的II期研究。[1]<\/span><\/sup>試驗包括20周的劑量遞增期和26周的劑量維持期,評估給藥劑量分別為0.6 mg、2.4 mg、3.6 mg和4.8 mg的療效。[1]<\/span><\/sup><\/p> \n

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

Survodutide是一種胰高血糖素\/GLP-1受體雙重激動劑,可同時激活GLP-1和胰高血糖素受體。這兩種受體在新陳代謝功能調控中起著至關重要的作用。[2]<\/span><\/sup>Survodutide由勃林格殷格翰和Zealand Pharma共同開發,是勃林格殷格翰在心-腎-代謝疾病領域研發產品組合的一部分。<\/p> \n

我們同時也在非酒精性脂肪性肝炎(NASH)和肝纖維化(F1\/F2\/F3期)成人患者中開展II期研究,評估Survodutide的療效。[3]<\/span><\/sup>試驗預計在2023年第4季度完成。Survodutide已獲得美國FDA針對其成人NASH適應癥的快速通道資格認定。[4]<\/span><\/sup><\/p> \n

超重和肥胖簡介<\/b><\/p> \n

2016年,全球超過19億成年人體重超重,超重定義為體重指數(BMI)達到25或更高。[5]<\/span><\/sup>其中超過6.5億人患有肥胖,肥胖定義為BMI達到30或更高。[6]<\/span><\/sup>世界肥胖聯盟預測,2025年全球超重或肥胖人數可能達到27億,將成為全球性健康難題,給個人、醫療保健系統和社會將帶來沉重的負擔。[6]<\/span><\/sup>超重和肥胖是復雜的慢性疾病,涉及脂肪的異常或過度蓄積,對個人整體健康構成威脅。[7]<\/span><\/sup><\/p> \n

關于勃林格殷格翰<\/b><\/p> \n

勃林格殷格翰致力于研究突破性療法,旨在變革生命,守護世世代代的健康。作為一家研發驅動的全球領先生物制藥企業,公司在醫療需求高度未得到滿足的領域通過創新展現價值。勃林格殷格翰自1885年成立以來一直是一家獨立的家族企業,始終著眼長遠與可持續發展。在人用藥品、動物保健兩大業務領域,全球有超過5.3萬名員工服務逾130個地區。更多詳情,請訪問:www.boehringer-ingelheim.com<\/p> \n

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

Zealand Pharma A\/S(納斯達克股票代碼:ZEAL)(簡稱"Zealand")是一家專注于發現和開發肽類藥物的生物技術公司。Zealand發明的10余種候選藥物已進入臨床開發,其中2種已上市,3種處于后期開發階段。該公司與多家制藥公司建立了開發合作伙伴關系,并為其上市產品建立了商業合作伙伴關系。<\/p> \n

Zealand 成立于 1998 年,總部位于丹麥哥本哈根,在包括波士頓在內的美國設有辦事處。有關 Zealand 業務和活動的更多信息,請訪問 www.zealandpharma.com<\/a><\/p> \n

參考文獻<\/b><\/p> \n

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久久久亚洲欧洲日产国码二区

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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