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Amylyx Pharmaceuticals Announces Completion of Enrollment in Pivotal Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia
Last participant has been randomized and dosed in the LUCIDITY trial of avexitide; LUCIDITY enrolled a total of 78 participants Topline data readout on
About this update from Amylyx Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nLast participant has been randomized and dosed in the LUCIDITY trial of avexitide; LUCIDITY enrolled a total of 78 participants\n\n\n\nTopline data readout on track; anticipated in Q3 2026\n\n\n\nLUCIDITY is evaluating the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16\n\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAmylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that the last participant has been randomized and dosed in the pivotal Phase 3 LUCIDITY clinical trial of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist with U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in post-bariatric hypoglycemia (PBH). LUCIDITY is a 16-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of avexitide in adults with PBH following Roux-en-Y gastric bypass (RYGB) surgery. Participants who complete the 16-week double-blind period are eligible to enter a 32-week open-label extension period. The trial has enrolled 78 participants, with topline data readout anticipated in Q3 2026. If approved, commercial launch of avexitide is anticipated in 2027.\n\n\n“We are pleased to have completed enrollment in our pivotal Phase 3 LUCIDITY trial, and we extend our gratitude to the LUCIDITY trial sites and participants for their continued contributions to the trial,” said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. “We remain encouraged by the statistically significant data generated in five previous Phase 1 and Phase 2 clinical trials of avexitide in PBH, including statistically significant reductions in hypoglycemic events. Early NDA-readiness preparations are currently underway, and we look forward to topline data expected in Q3 2026.”\n\n\n“Today, living with PBH means living with constant and unpredictable hypoglycemic events, which studies have shown are driven by an exaggerated GLP-1 response. These events can lead to severe medical consequences, such as seizures, loss of consciousness, emergency department visits, hospitalization, and long-term impacts, including cognitive dysfunction. The significant burden of this chronic metabolic condition can strip away independence, forcing many of my patients to w...