Amylyx Pharmaceuticals Advances Phase 3 Study on Avexitide for Post-Bariatric Hypoglycemia

Amylyx Pharmaceuticals, Inc. ((AMLX)) announced an update on their ongoing clinical study.

Amylyx Pharmaceuticals, Inc. is conducting a Phase 3 study titled A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia. The study aims to assess the efficacy and safety of avexitide, a treatment for post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery, by comparing it to a placebo. The significance lies in addressing PBH, a condition affecting patients post-surgery, by reducing hypoglycemic events.

The intervention being tested is avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist administered via subcutaneous injection. Its purpose is to reduce insulin secretion and manage hypoglycemic events in PBH patients.

The study follows an interventional design with random allocation and a parallel intervention model. It is double-blind, meaning neither participants nor investigators know who receives the treatment or placebo. The primary purpose is treatment-focused, aiming to evaluate avexitide’s effectiveness.

The study began on April 29, 2025, with an estimated primary completion date not specified. The last update was submitted on August 21, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.

This clinical update could positively influence Amylyx Pharmaceuticals’ stock performance by showcasing progress in addressing PBH, a niche yet significant market. Investors may view this as a promising development, especially if the study results are favorable. Competitors in the PBH treatment space may also feel the pressure to advance their research efforts.

The study is currently ongoing, with further details available on the ClinicalTrials portal.