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PCSK9抑制剂雷卡西马布对高脂血症和血葡萄糖的影响:一项随机,双盲,安慰剂控制的第1b/2期研究

Ye Hu¹, Chen Chen¹, Xiao Hui He¹

¹Department of Clinical Pharmacology, Beijing Luhe Hospital, Capital Medical University, Beijing 101199, China.

Biomedical and environmental sciences : BES

|November 6, 2025

概括

在患有高脂血症的中国患者中,雷卡西马布 (SHR-1209) 并没有对葡萄糖代谢产生不良影响. 这项研究表明,该药物对于患有或没有糖尿病的人来说是安全的,没有显示任何负面的血糖影响.

科学领域:

心血管医学心血管医学
内分泌学在内分泌学.
药理学药理学是指药理学的学科.

背景情况:

已知雷卡西马布 (SHR-1209) 可以降低低密度脂蛋白胆固醇.
雷卡西马布对葡萄糖代谢的影响尚未得到充分证实.
评估血糖影响对于患者的安全至关重要.

研究的目的:

评估雷卡西马布对血糖参数的影响.
为了研究其在患有高脂血症的中国人群中的安全性.
为了确定Recaticimab是否影响快餐血葡萄糖 (FPG) 和糖化血红蛋白 (HbA1c).

主要方法:

一项为期24周的随机对照试验,在110名高脂血症患者中比较Recaticimab与安慰剂.
禁食血葡萄糖 (FPG) 和糖化血红蛋白 (HbA1c) 的测量是纵向进行的.
重复测量混合效应模型分析了Recaticimab和血糖水平之间的关联.

主要成果:

在正常葡萄糖代谢的参与者中,HbA1c水平显著下降 (P=0.036).
在血糖代谢异常的参与者中,FPG水平显示出显著的时间效应 (P=0.016).
对于FPG或HbA1c,没有发现显著的组 × 时间相互作用,这表明基于基线葡萄糖状况没有差异效应.

结论:

雷卡西马布在正常或异常葡萄糖代谢的患者中没有表现出任何不良的血糖影响.
这些发现支持Recaticimab在患有或没有糖尿病的人群中的安全性.
雷卡西马布可以安全地用于高脂血症患者,无论他们的葡萄糖代谢状态如何.

关键词:

禁食的血葡萄糖禁食的血葡萄糖葡萄糖的高血糖是因为.这就是HbA1c.超脂血症是因为高脂血症这是一种PCSK9抑制剂.

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