Amylyx Pharmaceuticals has announced positive top-line results from its pivotal Phase 3 LUCIDITY trial evaluating avexitide, a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist being developed for the treatment of post-bariatric hypoglycemia (PBH).
In the Phase 3 LUCIDITY study, avexitide successfully met its primary endpoint, reducing the rate of Level 2 and Level 3 (severe) hypoglycemic events by 55%compared to placebo. The investigational therapy also demonstrated statistical significance across all key secondary endpoints, offering clinically meaningful control over severe blood glucose drops.
Post-bariatric hypoglycemia is a rare, debilitating complication that can develop following bariatric surgery. In individuals with PBH, meals trigger an exaggerated GLP-1 surge, driving excessive insulin secretion that leads to recurrent, unpredictable, and dangerously low blood glucose levels. Unlike widely known GLP-1 receptor agonists designed to stimulate GLP-1 activity, avexitide is engineered specifically to block the GLP-1 receptor, countering the overactive hormonal cascade at its source.
Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies available for patients suffering from post-bariatric hypoglycemia.
Based on the robust efficacy and safety profile demonstrated in the Phase 3 LUCIDITY trial, Amylyx plans to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2026, aiming to bring the first targeted therapeutic option to individuals living with PBH.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
