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, a glucagon-like peptide-1 receptor antagonist, in reducing hypoglycemic events in patients with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery.
The intervention being tested is avexitide, administered as a 90 mg subcutaneous injection once daily. Avexitide is designed to inhibit GLP-1 receptor signaling, thereby reducing insulin secretion and managing hypoglycemia.
The study employs a randomized, double-blind, placebo-controlled design with a parallel intervention model. Approximately 75 participants will be randomly assigned to either the avexitide or placebo group, with both participants and investigators blinded to the treatment assignments. The primary purpose of the study is treatment-focused.
The study began on April 29, 2025, with primary completion expected in the near future. The last update was submitted on July 1, 2025. These dates are crucial as they guide investor expectations regarding study progress and potential market entry.
This clinical update could positively influence Amylyx Pharmaceuticals’ stock performance by boosting investor confidence in the company’s research capabilities and potential market expansion. The study’s success may also impact competitors in the post-bariatric hypoglycemia treatment space.
The study is ongoing, and further details are available on the ClinicalTrials portal.