Amylyx Pharmaceuticals' GLP-1 receptor antagonist avexitide reduced dangerous blood sugar crashes (Level 2 and 3 hypoglycemia) by 55% compared to placebo in the Phase 3 LUCIDITY trial for post-bariatric hypoglycemia (PBH).
The trial enrolled 78 patients following Roux-en-Y gastric bypass surgery, met all primary and secondary endpoints, and showed no weight change or severe safety signals, with the most common side effects being diarrhea and injection site reactions.
Amylyx is now preparing a New Drug Application for avexitide and plans to file for FDA approval by year-end, positioning it as a potential first therapy for PBH.
Avexitide is a first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy designation, and earlier Phase 2b data showed up to a 64% reduction in hypoglycemic events with once‑daily dosing.
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