原始来源记录
决策级顶线结果
Amylyx：LUCIDITY 3期试验avexitide治疗PBH的topline结果呈阳性
LUCIDITY达到了FDA商定的主要终点，2/3级低血糖事件减少55%（p=0.000003），所有次要终点均达成。Amylyx计划于2026年底前提交avexitide的NDA。
关键事实
- 申报时间
- 2026年8月18日 11:09
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- P值
- 0.000003
- 降低
- 55%
- 参与者
- 78
来源摘录
EX-99.1 2 d180533dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia • LUCIDITY met FDA-agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003) • LUCIDITY met all secondary endpoints showing consistent, highly statistically significant, and clinically meaningful reductions in Level 2 by self-monitoring of blood glucose (SMBG), Level 2 by CGM, and Level 3 hypoglycemic events • Avexitide was generally well-tolerated with a favorable safety profile • Amylyx plans to submit an NDA for avexitide with the FDA by year-end; avexitide has Breakthrough T