CAMBRIDGE, Mass. — Amylyx Pharmaceuticals, Inc. announced it has completed enrollment in its pivotal Phase 3 LUCIDITY clinical trial evaluating avexitide, an investigational therapy for post-bariatric hypoglycemia (PBH), with topline results expected in the third quarter of 2026.
The final participant in the trial has been randomized and dosed, bringing total enrollment to 78 patients. The 16-week, multicenter, randomized, double-blind, placebo-controlled study is designed to assess the efficacy and safety of avexitide in adults who developed PBH following Roux-en-Y gastric bypass surgery.
Avexitide, a first-in-class glucagon-like peptide-1 receptor antagonist, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for PBH. Participants who complete the initial study period are eligible to enter a 32-week open-label extension.
“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.”
The study’s primary endpoint, agreed upon with regulators, measures the reduction in a composite of Level 2 and Level 3 hypoglycemic events through Week 16.
PBH is a chronic metabolic condition characterized by unpredictable and potentially severe drops in blood sugar following bariatric surgery. Patients can experience symptoms ranging from dizziness to seizures and loss of consciousness, often requiring emergency care.
“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 withdraw from their work and social lives,” said Marilyn Tan, MD, FACE, principal investigator of the LUCIDITY clinical trial and clinical professor of medicine at the Stanford School of Medicine. “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.”
The Phase 3 study builds on data from five prior clinical trials of avexitide in PBH, which demonstrated statistically significant reductions in hypoglycemic events and a generally favorable safety profile.
If approved, Amylyx expects to launch avexitide commercially in 2027.
