Amylyx posts Phase 3 LUCIDITY presentation on avexitide for post-bariatric hypoglycemia
AMLX•Trial design, safety, and regulatory plans
The trial enrolled 78 patients in a randomized, double-blind design, testing avexitide 90 mg once daily versus placebo over 16 weeks.
The safety profile was described as generally well tolerated, with no treatment-related serious adverse events; common events included diarrhea and injection-site reactions.
The company outlined plans for an FDA NDA submission by end-2026, targeting a potential commercial launch in 2027 if cleared.
Phase 3 LUCIDITY data meet primary and secondary endpoints
Amylyx highlighted Phase 3 LUCIDITY topline data for avexitide in post-bariatric hypoglycemia, meeting the primary endpoint and all secondary endpoints.
The primary endpoint showed a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events versus placebo at Week 16 (p=0.000003).
