在过重或肥胖的成年人中,每天服用一次口服50毫克的塞马格卢提德 (OASIS 1):一个随机,双盲,安慰剂对照的3期试验
在PubMed上查看摘要
概括
此摘要是机器生成的。在没有2型糖尿病的超重或肥胖成年人中,口服赛马格卢提德50 mg显著降低了体重. 与安慰剂相比,这种类似于葡萄糖的-1 类比在68周内显示出更高的疗效.
科学领域
- 药理学和治疗学
- 代谢疾病和内分泌学
- 临床试验研究
背景情况
- 肥胖和超重是全球重要的健康问题,需要有效的药物治疗.
- 葡萄糖类-1 (GLP-1) 受体激动剂在体重控制方面表现有前途.
- 在非糖尿病患者中,高剂量口服赛马格卢提德的疗效和安全性需要严格的临床评估.
研究的目的
- 与安慰剂相比,每天服用50毫克西马格卢提德的减肥效果进行评估.
- 在该群体中评估口服50毫克的安全性和耐受性.
- 确定服用50毫克西马格卢提德可显著减轻体重的参与者比例.
主要方法
- 一个随机的,双盲的,安慰剂控制的,第三阶段的优势试验.
- 包括没有2型糖尿病的BMI≥30kg/m2或≥27kg/m2的成年人.
- 68周的治疗时间,服用50毫克西马格卢提德或安慰剂,结合生活方式干预.
- 主要终点:体重百分比变化和68周体重减轻≥5%的比例 (治疗意向分析).
主要成果
- 服用50毫克西马格卢提德的平均体重减轻率为-15. 1%,而服用安慰剂的平均减轻率为- 2. 4% (p< 0. 0001).
- 显著更高的比例实现了≥5%,10%,15%和20%的体重减轻与semaglutide.
- 与安慰剂 (86%) 相比,西马格卢提德的不良反应更频繁,主要是轻度至中度的胃肠道问题.
结论
- 每天服用50毫克的西马格卢提德可以在超重或肥胖的成年人中降低体重,并且具有临床意义.
- 这项研究证实了高剂量口服赛马格卢提德作为治疗选择的有效性.
- 胃肠道副作用是常见的,但通常可以控制,支持药物的长期使用潜力.
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