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歌禮制藥-B(01672.HK)宣佈ASC47單藥療法澳大利亞Ib期研究取得積極頂線結果及ASC47聯合司美格魯肽的新藥臨牀試驗申請獲美國FDA批準
格隆匯 03-12 07:20

格隆匯3月12日丨歌禮制藥-B(01672.HK)宣佈ASC47澳大利亞Ib期低密度脂蛋白膽固醇(LDL-C)偏高的健康受試者(第一部分)和肥胖症患者(第二部分)中的單次皮下注射研究(NCT06427590)取得令人振奮的藥代動力學和減重數據。

ASC47是一款脂肪靶向、治療肥胖症的減重不減肌的候選藥物,其在低密度脂蛋白膽固醇(LDL-C)偏高的健康受試者和肥胖症患者中的Ib期單次皮下注射研究分別顯示出了長達26天和40天的半衰期,支持每月一次至每兩月一次給藥。

ASC47在LDL-C偏高的健康受試者和肥胖症患者中均安全且耐受性良好。此前的臨牀前數據顯示,在頭對頭飲食誘導肥胖(DIO)小鼠模型中,低劑量ASC47與司美格魯肽(semaglutide)聯合用藥比司美格魯肽單藥療法多減重56.7%。美國食品藥品監督管理局批準脂肪靶向甲狀腺激素受體β(THRβ)選擇性激動劑ASC47與腸促胰素類藥物聯用臨牀試驗,表明了對這一概念性驗證臨牀試驗的認可和支持。

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