Amylyx Completes Phase 3 Enrollment For Avexitide In Post-Bariatric Hypoglycemia, Data Expected 2026

Amylyx Pharmaceuticals has completed patient enrollment and dosing in its pivotal Phase 3 LUCIDITY trial evaluating avexitide, an investigational GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH). The therapy has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The study targets adults who developed PBH following Roux-en-Y gastric bypass surgery and represents a major milestone in advancing a potential first-in-class treatment.

“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.”

LUCIDITY is a 16-week, multicenter, randomised, double-blind, placebo-controlled study designed to assess avexitide’s efficacy and safety. Participants who finish the blinded phase may continue into a 32-week open-label extension. A total of 78 patients have been enrolled, with topline results expected in the third quarter of 2026. Pending regulatory approval, Amylyx anticipates launching the therapy commercially in 2027.

“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, hospitalisation, 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 withdraw from their work and social lives,” said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY clinical trial. “Preventing even a single event could meaningfully improve someone’s quality of life, and there is an urgent need for medicine to treat this devastating condition.” Dr Tan is also a Clinical Professor of Medicine at the Stanford School of Medicine.

The trial’s primary endpoint, agreed upon with regulators, measures reductions in moderate-to-severe hypoglycemic episodes (Levels 2 and 3) through Week 16. Its design builds on findings from five prior PBH trials, where avexitide consistently demonstrated statistically significant reductions in serious hypoglycemic events and maintained a favourable tolerability and safety profile.