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肥胖成年人每周服用一次7.2毫克西马格卢提德 (STEP UP):一种随机对照的3b期试验

Sean Wharton¹, Paula Freitas², Jøran Hjelmesæth³

¹Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Faculty of Health and Kinesiology, York University, Toronto, ON, Canada; Faculty of Medicine, McMaster University, Hamilton, ON, Canada; Wharton Medical Clinic Weight and Diabetes Management, Burlington, ON, Canada.

The lancet. Diabetes & endocrinology

|September 17, 2025

概括

与较低剂量 (2.4 mg) 和安慰剂相比,较高剂量 (7.2 mg) 的西马格卢提德显著改善了肥胖成年人的体重减轻. 这种较高的剂量显示出有利的风险-益处概况,提供了更有效的体重管理解决方案.

科学领域:

内分泌学在内分泌学.
代谢疾病代谢疾病
药理学药理学是指药理学的学科.

背景情况:

每周一次的皮下塞马格卢提德2.4毫克被批准用于肥胖管理.
一些患者在2.4毫克的剂量下无法达到治疗目标.
更高的剂量可能会为体重管理提供更高的疗效.

研究的目的:

评估更高剂量的塞马格卢提德 (7.2毫克) 对肥胖成年人体重管理的疗效和安全性.
为了比较7.2毫克塞马格卢提德与2.4毫克塞马格卢提德和安慰剂的作用.

主要方法:

STEP UP试验:第3b期,随机,双盲,安慰剂和活性控制的研究.
1407名BMI≥30kg/m2 (没有糖尿病) 的成年人每周接受一次7.2毫克,2.4毫克或安慰剂,持续72周,并进行生活方式干预.
共同初级终点:体重的百分比变化和从基线到第72周实现≥5%体重减轻的比例.

主要成果:

与2.4毫克 (-18.7%对 -15.6%) 和安慰剂 (-18.7%对 -3.9%) 相比,7.2毫克西马格卢提德导致显著更大的体重减轻.
与安慰剂和2.4毫克相比,7.2毫克的参与者比例更高,实现了显著的体重减轻 (≥5%,10%,15%,20%,25%).
用7.2mg与安慰剂观察到腰围的改善;胃肠道不良事件在较高剂量时更为常见.

结论:

与安慰剂和2.4毫克相比,7.2毫克的塞马格卢提德在肥胖的成年人体内减轻体重方面表现出更好的疗效.
7.2毫克的剂量保持了有利的风险-益处概况,表明肥胖管理的治疗潜力得到了增强.

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