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 efficacy and safety of avexitide, a treatment for post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass, by measuring the reduction of hypoglycemic events.
The intervention being tested is avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist. It is administered as a 90 mg subcutaneous injection once daily to reduce insulin secretion mediated by the GLP-1 receptor.
The study is interventional with a randomized, parallel assignment model. It is double-blind, meaning neither participants nor investigators know who receives the treatment or placebo. The primary purpose is treatment, with approximately 75 participants randomized in a 3:2 ratio to receive either avexitide or placebo.
The study began on December 18, 2024, with the last update submitted on October 8, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
The update from Amylyx Pharmaceuticals could influence its stock performance and investor sentiment, given the potential market for effective PBH treatments. Competitors in the GLP-1 receptor antagonist space may also be impacted as the study progresses.
The study is ongoing, with further details available on the ClinicalTrials portal.