6月23日,礼来于上周六公布了其口服小分子GLP-1类药物orforglipron在三期临床试验ACHIEVE-1中的详细数据。数据显示,在所有剂量组中,这款在研药物实现了2型糖尿病成人患者糖化血红蛋白平均1.3%至1.6%的降幅,且在用药四周内就可观察到改善,同时,高剂量组在第40周时实现平均体重减轻近8%。
据悉,在试验中,orforglipron被每日一次服用,剂量为3毫克、12毫克和36毫克。结果显示,只有12毫克和36毫克剂量组在体重减轻方面相较于安慰剂显示出具有临床意义且统计显著的效果。此外,礼来指出,orforglipron的安全性表现与GLP-1药物类别的既往耐受性数据一致,胃肠道不适为报告频率最高的不良事件。
未来几个月将有多个orforglipron的关键三期临床数据公布,其中一项对比诺和诺德(NVO.US)口服司美格鲁肽的三期试验初步数据预计将在今年晚些时候发布。与此同时,两项三期临床试验ATTAIN-1和ATTAIN-2(测试Orforglipron在体重管理中的效果)预计将于2025年第三季度公布结果。礼来计划在2025年底之前递交全球监管申请,以推动该药在肥胖症适应症方面的上市进程。
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