Amylyx reports positive Phase 3 LUCIDITY results for avexitide in post-bariatric hypoglycemia

Amylyx Pharmaceuticals, Inc.

• LUCIDITY met primary endpoint: 55% reduction in composite Level 2/3 hypoglycemic events vs placebo (p=0.000003).
• All secondary endpoints met: reductions in SMBG-measured Level 2, CGM-measured Level 2, and adjudicated Level 3 events.
• Trial enrolled 78 adults with PBH post-RYGB; randomized 3:2 to 90 mg avexitide SC daily or placebo.
• NDA submission to FDA planned by end of 2026; avexitide has Breakthrough Therapy and Orphan Drug designations.
• Avexitide well-tolerated; no serious AEs related to treatment; common AEs: diarrhea, injection site erythema, bruising.