Amylyx Pharmaceuticals reported positive topline results from its Phase 3 LUCIDITY trial of avexitide, an investigational treatment for post-bariatric hypoglycemia in adults who previously underwent Roux-en-Y gastric bypass surgery.
The randomized, double-blind, placebo-controlled study met its FDA-agreed primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events through Week 16 for patients receiving avexitide compared with placebo. The result was highly statistically significant, with a p-value of 0.000003.
The trial enrolled 78 participants with post-bariatric hypoglycemia, a condition marked by recurrent low blood sugar after bariatric surgery. Avexitide was administered as a 90 mg subcutaneous injection once daily.
Amylyx said the study also met all secondary endpoints. Those measures included statistically significant and clinically meaningful reductions in Level 2 hypoglycemic events measured through self-monitoring of blood glucose, continuous glucose monitoring and Level 3 events independently assessed by an event-adjudication committee.
Level 2 hypoglycemia refers to clinically significant low blood sugar, while Level 3 events are severe episodes requiring assistance from another person.
Avexitide was generally well tolerated during the 16-week double-blind phase, according to Amylyx. Most treatment-emergent adverse events were mild or moderate. The company reported no serious adverse events related to avexitide and no observed difference in body weight compared with placebo.
The LUCIDITY trial includes a 32-week open-label extension, which remains ongoing. Participants who received placebo during the double-blind period may transition to avexitide in the extension portion of the study.
Avexitide is a first-in-class glucagon-like peptide-1 receptor antagonist. It is designed to address excessive insulin secretion associated with post-bariatric hypoglycemia, a potentially serious complication that can occur after Roux-en-Y gastric bypass surgery.
Amylyx said it plans to submit a New Drug Application for avexitide to FDA by the end of 2026. If approved, the company is preparing for a potential U.S. commercial launch in 2027.
The drug remains investigational and has not been approved for use in post-bariatric hypoglycemia.
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