Amylyx Pharmaceuticals announced that its experimental drug, avexitide, met the primary endpoint of the Phase 3 LUCIDITY trial. The study focused on post-bariatric hypoglycemia (PBH), a condition causing dangerously low blood sugar after weight-loss surgery. No FDA-approved treatments currently exist for this condition.
Avexitide reduced the rate of significant and severe hypoglycemic events by 55% compared to a placebo. The drug was generally well-tolerated and showed no treatment-related serious adverse events.
Amylyx plans to file for FDA approval by the end of 2026.