智通财经APP获悉,4月17日,礼来(LLY.US)宣布III期ACHIEVE-1研究取得积极结果,该研究评估了orforglipron与安慰剂相比在饮食和运动单独控制不佳的2型糖尿病成人中的安全性和疗效。Orforglipron是首个成功完成III期研究的口服小分子胰高血糖素样肽-1(GLP-1)受体激动剂,服用时无需食物和水限制。礼来表示未来该药如果获批,将对其能够在全球范围内推出orforglipron且不受供应限制充满信心。
在ACHIEVE-1研究中,orforglipron达到了与安慰剂相比在40周时A1C降低更优的主要终点,从8.0%的基线平均降低A1C 1.3%至1.6%,使用疗效估计量。在一个关键的次要终点中,超过65%接受最高剂量orforglipron治疗的受试者者实现了A1C小于或等于6.5%,低于美国糖尿病协会(ADA)定义的糖尿病阈值。在另一个关键的次要终点中,接受orforglipron治疗的受试者在最高剂量下平均减重16.0磅(7.9%)。鉴于受试者在研究结束时尚未达到体重平台期,可能表明尚未实现完全减重。
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