过重/肥胖的中国成年人中的HDM1002:一个随机的,安慰剂控制的,上升剂量的1b期研究
Hongrong Xu1, Wei Hu2, Lin Zhao3
1Department of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai, China.
Obesity (Silver Spring, Md.)
|March 10, 2026
概括
HDM1002,一种类似葡萄糖-1受体激动剂,在中国成年人中显示出可管理的安全性. 该药物导致显著的体重减轻,但没有影响血糖.
科学领域:
- 药理学 药理学是指药理学的学科.
- 代谢疾病 代谢疾病
- 临床试验 临床试验
背景情况:
- 葡萄糖类-1 (GLP-1) 受体激活剂是代谢障碍的一个关键治疗类.
- HDM1002是一种新的小分子GLP-1受体激动剂.
研究的目的:
- 评估HDM1002在中国参与者的安全性,耐受性,药理动力学 (PK) 和药理动力学 (PD).
- 评估安全性和有效性终点的剂量反应关系.
主要方法:
- 在中国成年人 (BMI 24.0-36.0 kg/m2) 进行了一项随机,双盲,安慰剂对照试验.
- 参与者接受口服HDM1002 (50-400毫克/天) 或安慰剂28天以5:1的比例.
- 安全性通过治疗出现的不良事件 (TEAE),生命体征,心电图和实验室测试来评估;PK/PD是次要终点.
主要成果:
- 治疗出现的不良事件 (TEAE) 是轻度/中度,在HDM1002组的70-100%发生,而安慰剂组的60%发生.
- 由于TEAE,两名参与者停止了HDM1002的使用.
- 观察到高剂量的HDM1002显著减轻体重 (例如,200毫克QD -6.1公斤),但与安慰剂相比,对血糖没有显著影响.
- 药物动力学通常与剂量成比例.
结论:
- 在这个中国人群中,HDM1002表现出可管理的安全性和耐受性.
- 这种药物显示出降低体重的潜力,需要进一步调查.
- 在这项短期研究中,没有观察到对血糖控制的显著影响.
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