Amylyx reports positive Phase 3 results for avexitide in post-bariatric hypoglycemia

Amylyx Pharmaceuticals announced on August 18, 2026 that its Phase 3 LUCIDITY trial of avexitide met its primary endpoint in patients with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery. The trial was a 78-participant, multicenter, randomized, double-blind, placebo-controlled study testing avexitide, described as an investigational, first-in-class GLP-1 receptor antagonist, in people with PBH after gastric bypass.¹

The study achieved the FDA-agreed primary endpoint, showing a 55% reduction in the combined rate of Level 2 and Level 3 hypoglycemic events versus placebo, with a p-value of 0.000003.¹ The trial also met all of its secondary endpoints, showing statistically significant and consistent drops in Level 2 events measured by self-monitored blood glucose and continuous glucose monitoring, as well as in Level 3 events.¹

On dosing, participants were randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo.¹

Safety results were favorable. Avexitide was generally well-tolerated during the double-blind period, with a safety profile consistent across earlier PBH studies, and most adverse events were mild to moderate with no serious drug-related events reported.¹ The most frequent side effects were diarrhea and injection-site erythema and bruising.¹ No body-weight changes were seen in either treatment arm over the 16-week double-blind period.¹

Looking ahead, Amylyx said it plans to submit a New Drug Application to the FDA by the end of 2026.¹ The FDA has already granted avexitide Breakthrough Therapy Designation for PBH.¹ The trial's 32-week open-label extension and the avexitide expanded access program both remain ongoing.¹ Company executives said preparations continue for a potential commercial launch in 2027, if approved.¹