歌禮制藥-B(01672.HK):甘萊NASH候選藥物ASC41完成Ib期臨試超重和肥胖受試者給藥
格隆匯 12 月 22日丨歌禮制藥-B(01672.HK)發佈公告,公司全資附屬公司甘萊製藥有限公司(“甘萊”)的口服片劑ASC41 Ib期臨牀試驗完成超重和肥胖受試者給藥。ASC41是一種具有肝臟靶向性的前體藥物,其活性成分ASC41-A是一種具有選擇性的THR-β激動劑。
公告表示,在這項隨機、雙盲、安慰劑對照的Ib期臨牀研究中,研究對象為低密度脂蛋白膽固醇(LDL-C)大於110 mg/dL的超重和肥胖受試者。治療持續時間為28天,每日給藥一次,每次口服10 mg。本試驗旨在評估以下指標:1)ASC41對心臟健康標誌物即LDL-C、甘油三酯(TG)、總膽固醇(TC)、高密度脂蛋白膽固醇(HDL-C)的影響;2)ASC41片劑的安全性和耐受性;3)ASC41片劑及其活性成分ASC41-A在超重和肥胖受試者中的藥代動力學數據。
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