潜在首款！礼来Tirzepatide治疗阻塞性睡眠呼吸暂停III期研究成功

医药魔方04-18

4月17日，礼来宣布其GLP-1R/GIPR双重激动剂Tirzepatide（替尔泊肽）用于治疗中度至重度阻塞性睡眠呼吸暂停（OSA）合并肥胖的III期SURMOUNT-OSA临床试验获得积极结果。与安慰剂相比，Tirzepatide注射液（10mg或15mg）显著降低了受试者呼吸暂停低通气指数（AHI），达到了主要终点。AHI记录了受试者每小时睡眠中呼吸受限或气流完全阻塞的次数，用于评估OSA的...

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Successful Phase III study of Lilly Tirzepatide in the treatment of obstructive sleep apnea","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"III":1,"LLY":1},"content_text":"4月17日，礼来宣布其GLP-1R/GIPR双重激动剂Tirzepatide（替尔泊肽）用于治疗中度至重度阻塞性睡眠呼吸暂停（OSA）合并肥胖的III期SURMOUNT-OSA临床试验获得积极结果。与安慰剂相比，Tirzepatide注射液（10mg或15mg）显著降低了受试者呼吸暂停低通气指数（AHI），达到了主要终点。AHI记录了受试者每小时睡眠中呼吸受限或气流完全阻塞的次数，用于评估OSA的严重程度和治疗结果的有效性。Tirzepatide是目前唯一被批准用于慢性体重管理的GLP-1R/GIPR类药物，其在美国以商品名Zepbound进行商业化，在美国以外的一些全球市场以商品名Mounjaro进行商业化。此次OSA适应症III期成功意味着Tirzepatide将打开减重之外的又一个市场。SURMOUNT-OSA Study 1评估了Tirzepatide在未接受正压通气（PAP）治疗的中度至重度OSA合并肥胖成人患者中的疗效。研究结果显示，在52周时，Tirzepatide组受试者平均AHI较基线降低了27.4次/小时，而安慰剂组降低了4.8次/小时。在关键的次要结局中，Tirzepatide可使平均AHI较基线降低55.0%，而安慰剂组降低了5.0%；Tirzepatide还使患者的平均体重较基线减少18.1%，而安慰剂组的平均体重较基线仅减少1.3%。SURMOUNT-OSA Study 2评估了Tirzepatide在接受并计划继续进行PAP治疗的中重度OSA合并肥胖成人中的疗效。结果显示，在52周时，Tirzepatide组受试者平均AHI较基线降低了30.4次/小时，而安慰剂平均降低了6.0次/小时。在关键的次要结局中，Tirzepatide可使平均AHI较基线降低62.8%，而安慰剂组为6.4%；Tirzepatide还使患者的平均体重较基线降低了20.1%，而安慰剂组降低了2.3%。在SURMOUNT-OSA研究中，Tirzepatide的总体安全性与先前报道的SURMOUNT和SURPASS试验中的结果相似，最常报道的是胃肠道相关不良事件，严重程度一般为轻至中度。基于这些结果，礼来计划在年中开始向美国FDA和其他全球监管机构提交上市申请，此前，Tirzepatide已获得FDA授予的用于治疗中重度OSA合并肥胖的快速通道认定。阻塞性睡眠呼吸暂停（OSA）是一种与睡眠相关的呼吸障碍，其特征是睡眠时患者上呼吸道完全或部分塌陷，导致呼吸暂停或呼吸不足，并可能导致血氧饱和度降低和/或患者从睡眠中醒来。阻塞性睡眠呼吸暂停会导致严重的心脏代谢并发症，包括高血压、冠心病、中风、心力衰竭、心房颤动和2型糖尿病等。“在美国，有8000万成年人受到OSA综合征的影响，其中超过2000万人患有中度至重度OSA。然而，85%的OSA病例未被诊断，因此未得到治疗，”礼来公司产品开发高级副总裁Jeff Emmick博士说。“正面解决这一未满足的需求是至关重要的，虽然有药物获批治疗OSA相关的过度嗜睡，不过Tirzepatide有可能成为治疗OSA的第一种药物。”Copyright © 2024 PHARMCUBE. 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