Amylyx Pharmaceuticals, Inc. ((AMLX)) announced an update on their ongoing clinical study.
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Amylyx Pharmaceuticals, Inc. (AMLX) 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 individuals who have undergone Roux-en-Y gastric bypass surgery and experience post-bariatric hypoglycemia (PBH).
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 by inhibiting GLP-1 receptor signaling, potentially mitigating hypoglycemic episodes in PBH patients.
This interventional study employs a randomized, parallel assignment model with double masking for participants and investigators. The primary purpose is treatment, with participants allocated to either avexitide or placebo groups in a 3:2 ratio during the double-blind period.
The study commenced on April 29, 2025, with primary completion anticipated in the near future. The latest update was submitted on July 1, 2025, indicating ongoing recruitment and study progress.
The successful development of avexitide could significantly impact Amylyx Pharmaceuticals’ stock performance by enhancing its portfolio with a novel treatment for PBH. This could also influence investor sentiment positively, especially in comparison to competitors lacking similar innovations in this niche market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.