LUCIDITY Trial Positive for Avexitide in Post-Bariatric Hypoglycemia

August 19, 2026 at 11:44

Amylyx Pharmaceuticals reported positive topline results from LUCIDITY, a phase 3 trial evaluating avexitide, which the company described as an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, in adults with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery. The multicenter, randomized, double-blind, placebo-controlled study enrolled 78 participants, and the company said it met an FDA-agreed primary efficacy endpoint through week 16.

Participants were randomized 3:2 to receive avexitide 90mg subcutaneously once daily or placebo during the 16-week double-blind period. The company reported a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events with avexitide versus placebo (p=0.000003).

Amylyx said LUCIDITY also met all secondary endpoints, with reductions in Level 2 events measured by self-monitoring of blood glucose, Level 2 events measured by continuous glucose monitoring, and independently adjudicated Level 3 events.

Avexitide was generally well tolerated through the double-blind period, according to the release. Most adverse events were mild to moderate, and no serious adverse events related to avexitide were reported. The most common adverse events were diarrhea, injection-site erythema, and injection-site bruising. Neither group had changes in body weight over 16 weeks.

According to Amylyx, there are currently no FDA-approved therapies for PBH. The company plans to submit a New Drug Application by the end of 2026. The FDA has granted avexitide Breakthrough Therapy designation for PBH and Orphan Drug designation for hyperinsulinemic hypoglycemia, which includes PBH and congenital hyperinsulinism. The trial’s 32-week open-label extension and the expanded access program remain ongoing, and Amylyx said it plans to present the LUCIDITY data at an upcoming medical meeting.