Amylyx Announces Phase 3 Trial for Avexitide in Post-Bariatric Hypoglycemia

Based in Cambridge, MA, Amylyx Pharmaceuticals revealed that it will be initiating LUCIDITY, its pivotal Phase 3 trial assessing avexitide in the management of PBH. The purpose of this trial is to compare the decrease in hypoglycemia events in patients who have been through the RYGB surgery. Since the study is intended to start enrolling participants in early 2025, Amylyx expects to wrap up recruitment by the end of the year and report interim data in 2026. The LUCIDITY trial is in line with previous clinical trials, showing efficacy of avexitide as a first therapeutic option for PBH, approved by the FDA.

The LUCIDITY trial will be a phase II multicenter randomised, double-blind, placebo-controlled trial with approximately 75 patients. Participants will be assigned to take 90 mg of avexitide or placebo daily over 16 weeks. The main objective of the trial is to assess the effectiveness of the drug in lowering the incidences of Level 2 and Level 3 hypoglycemic events among PBH patients. Safety/tolerability will also be evaluated, and all participants will have the option of continuing on to an open-label extension for an additional 32 weeks.

Avexitide has also displayed high efficacy and safety in several previous clinical trials where it also lowered the likelihood of hypoglycemia for PBH patients. The Phase 2 study proved that avexitide significantly reduces the incidencee of hypoglycemic events by up to 66%, as patients described fewer incidences of severe hypoglycemia. Avexitide with FDA Breakthrough Therapy and Orphan Drug Designations brings new perspective for PBH patients who suffer from the loss of quality of life because of the recurrent and severe hypoglycemic events. Amylyx believes avexitide has the potential to be impactful for PBH patients, and the company is ready to proceed with Phase 3.