CAMBRIDGE, Mass.– Amylyx Pharmaceuticals presented new exploratory analyses from its Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH), at the Endocrine Society’s annual meeting (ENDO 2025). The results continue to build momentum for avexitide as a potential first-in-class therapy for a serious and currently untreatable condition.
In the Phase 2b study, avexitide 90 mg once daily—the dose currently being tested in the pivotal Phase 3 LUCIDITY trial—led to a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to baseline. More than half of trial participants experienced no Level 2 or 3 hypoglycemic episodes during the treatment period. These outcomes support the FDA-agreed primary endpoint for LUCIDITY, which is expected to complete enrollment in 2025 with topline results anticipated in the first half of 2026.
“Post-bariatric hypoglycemia can profoundly disrupt daily life,” said Dr. Marilyn Tan, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University. “The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events.”
Additional data shared at ENDO 2025 demonstrated that the 90 mg once-daily regimen provides sustained therapeutic exposure over a 24-hour period. Pharmacokinetic and pharmacodynamic modeling confirmed continuous GLP-1 receptor inhibition, with plasma levels consistently exceeding the IC₅₀ threshold throughout the dosing interval.
Camille L. Bedrosian, M.D., Chief Medical Officer at Amylyx, emphasized the clinical significance of the findings. “Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments,” she said. “The exploratory analysis from our Phase 2 and 2b trials shows that avexitide substantially reduces dangerous hypoglycemic episodes, with over half of patients experiencing none at all during treatment.”
Avexitide has shown consistent, dose-dependent efficacy across five clinical trials to date and continues to exhibit a favorable safety profile. The company expects to complete recruitment for the LUCIDITY trial by the end of 2025 and anticipates a commercial launch in 2027, pending regulatory approval.
