歌禮制藥-B(01672.HK)宣佈脂肪靶向、每月一次注射劑、小分子THRβ激動劑ASC47聯合司美格魯肽治療肥胖症的美國臨牀研究完成首批受試者給藥
格隆匯5月20日丨歌禮制藥-B(01672.HK)宣佈，旨在評估超長效皮下注射ASC47單次給藥聯合司美格魯肽在不伴有2型糖尿病的肥胖受試者中的安全性及初步療效的隨機、雙盲、安慰劑對照研究(「ASC47-103研究」)已完成首批受試者給藥。ASC47-103研究在美國開展，共設3個隊列，受試者接受ASC47單劑量遞增(10毫克、30毫克和60毫克)或注射等量(volume-matched)安慰劑。各隊列受試者還將接受四次司美格魯肽(0.5毫克，每週一次)注射(NCT06972992)。
ASC47是一款由歌禮自主研發的、脂肪靶向、超長效皮下注射的甲狀腺激素受體β(THRβ)選擇性小分子激動劑。ASC47具有獨特的差異化特性，能夠靶向脂肪，從而在脂肪組織中產生劑量依賴性的高藥物濃度。ASC47單藥療法在Ib期肥胖受試者研究中顯示出長達40天的半衰期。在頭對頭比較的飲食誘導肥胖小鼠模型中，低劑量ASC47與司美格魯肽聯合用藥比司美格魯肽單藥療法多減重56.7%，且不減肌。
ASC47-103研究的頂線數據預計將於2025年第四季度公佈。
據悉，ASC47-103研究是一項在美國開展的隨機、雙盲、安慰劑對照的臨牀研究，旨在評估超長效皮下注射ASC47單次給藥聯合司美格魯肽在肥胖受試者(體重指數≥30kg/m2)中的安全性及初步療效。該研究共設3個隊列：隊列1的受試者將接受皮下注射一次10毫克ASC47或等量(volume-matched)安慰劑，及皮下注射四次司美格魯肽(0.5毫克，每週一次)；隊列2的受試者將接受皮下注射一次30毫克ASC47或等量(volume-matched)安慰劑，及皮下注射四次司美格魯肽(0.5毫克，每週一次)；隊列3的受試者將接受皮下注射一次60毫克ASC47或等量(volume-matched)安慰劑，及皮下注射四次司美格魯肽(0.5毫克，每週一次)。
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