Amylyx Pharmaceuticals, Inc. ((AMLX)) announced an update on their ongoing clinical study.
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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 safety and efficacy of avexitide in reducing hypoglycemic events in patients with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery.
The intervention being tested is avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, administered via subcutaneous injection. It is designed to reduce insulin secretion and manage hypoglycemia in affected patients.
The study is randomized and double-blind, involving approximately 75 participants who will receive either avexitide or a placebo. The primary purpose is treatment, with both participants and investigators unaware of the treatment assignments to ensure unbiased results.
The study began on April 29, 2025, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on August 4, 2025, indicating ongoing recruitment.
This clinical study could significantly impact Amylyx Pharmaceuticals’ stock performance, as positive results may enhance investor confidence and market position, especially in the competitive field of post-bariatric treatment options.
The study is currently ongoing, with further details available on the ClinicalTrials portal.