礼来首个小分子口服GLP-1药物3期临床研究成功有望颠覆减重药物格局_老虎社区_美港股上老虎

礼来首个小分子口服GLP-1药物3期临床研究成功有望颠覆减重药物格局

证券日报2025-04-18

本报讯（记者李春莲见习记者梁傲男）4月17日，全球制药巨头礼来公司公布了3期临床研究ACHIEVE-1的积极顶线结果，该研究评估了Orforglipron与安慰剂相比，在患有2型糖尿病和仅通过饮食和运动控制不足的成人中的安全性和有效性。　　4月17日，礼来股价收涨超14%，创下自2023年8月份以来的最大单日涨幅。　　在业内人士看来，GLP-1减肥药领域正在从注射剂型向便捷的口服形式转变，而礼来...

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（记者李春莲见习记者梁傲男）4月17日，全球制药巨头礼来公司公布了3期临床研究ACHIEVE-1的积极顶线结果，该研究评估了Orforglipron与安慰剂相比，在患有2型糖尿病和仅通过饮食和运动控制不足的成人中的安全性和有效性。　　4月17日，礼来股价收涨超14%，创下自2023年8月份以来的最大单日涨幅。　　在业内人士看来，GLP-1减肥药领域正在从注射剂型向便捷的口服形式转变，而礼来已经取得了早期领先优势，有望颠覆减重药物格局。　　据礼来介绍，Orforglipron是首款无需饮食、饮水控制的口服小分子GLP-1受体激动剂。礼来方面表示，如果该药物未来获批，公司对其实现全球充足的供应充满信心。这将进一步实现礼来长期以来的使命——降低包括2型糖尿病在内的慢性病的影响。　　“目前共有7项评估Orforglipron在糖尿病和肥胖人群中安全性和有效性的3期临床试验，ACHIEVE-1则是其中的首个研究。作为最新的肠促胰岛素类药物，我们很高兴看到它达到了我们对其安全性、耐受性、血糖控制和减重的各项预期，今年年底前我们将获得有关这一研究的更多数据。”礼来制药董事长兼首席执行官戴文睿表示。　　研究显示，在ACHIEVE项目的第一项3期临床试验中，Orforglipron达到了主要终点，即在40周时，经Orforglipron治疗后糖化血红蛋白（A1C）的降幅显著优于安慰剂组，A1C自8.0%的基线平均降低1.3%至1.6%（使用有效性估计目标）。在关键次要终点，超过65%的患者接受最高剂量的Orforglipron后A1C值降至≤6.5%，低于美国糖尿病协会定义的糖尿病阈值。在另一个关键次要终点，接受Orforglipron的患者在最高剂量下平均减重7.3kg。鉴于患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。　　礼来方面预计，将在今年年底前向全球监管机构提交Orforglipron用于体重管理的上市申请，预计于2026年提交其用于治疗2型糖尿病的上市申请。（文章来源：证券日报）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"hasMoreComments":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":1,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"isCrawlerRequest":true}