Amylyx's avexitide hits primary endpoint in Phase 3 LUCIDITY for post-bariatric hypoglycaemia
Amylyx Pharmaceuticals reported positive topline results on 18 August 2026 from LUCIDITY, its pivotal Phase 3 trial of avexitide in post-bariatric hypoglycaemia (PBH). The 78-participant, randomised, double-blind, placebo-controlled study met its FDA-agreed primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycaemic events versus placebo (p=0.000003) through Week 16.
Avexitide, a first-in-class GLP-1 receptor antagonist, also met all secondary endpoints, with consistent, statistically significant reductions in Level 2 events by self-monitoring of blood glucose and by continuous glucose monitoring, and in adjudicated Level 3 events. Participants had PBH following Roux-en-Y gastric bypass surgery and were randomised 3:2 to 90 mg avexitide once daily or placebo. The drug was generally well tolerated, with mostly mild-to-moderate adverse events and no serious treatment-related events; no changes in body weight were observed.
Amylyx plans to submit a New Drug Application to the FDA by year-end. Avexitide holds Breakthrough Therapy and Orphan Drug designations, and if approved would be the first treatment for PBH.
