New Phase II data presented at ENDO 2025 highlight avexitide’s potential to significantly reduce severe hypoglycemic events in patients with post-bariatric hypoglycemia, with Phase III results expected in 2026.
Amylyx has announced new exploratory analyses from two Phase II clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH). These data were presented at the Endocrine Society’s annual meeting (ENDO 2025).1
In a Phase IIb study (NCT04652479), avexitide at a dose of 90 mg once daily demonstrated a 64% least-squares mean reduction (p=0.0031) versus baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH. Further, more than half of the participants did not experience any events during the treatment period.
This trial also evaluated avexitide at 45 mg twice daily, which showed consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events.
Meanwhile, new data from the Phase II PREVENT trial (NCT03373435) also showed consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events, but at doses of 30 mg twice daily and 60 mg once daily.
In addition to the new Phase II analyses of avexitide, Amylyx provided an update on its Phase III LUCIDITY trial (NCT06747468) of avexitide. According to the company, LUCIDITY was informed by positive, consistent data stemming from five PBH studies. Recruitment is expected to be completed this year with the first data readout anticipated in the first half of 2026. If avexitide is approved, Amylyx expects commercial launch in 2027.
In a press release, Marilyn Tan, MD, FACE, principal investigator of the LUCIDITY trial and clinical associate professor at Stanford University, said: “Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events.”
In July 2024, Amylyx acquired avexitide from Eiger BioPharmaceuticals. Additionally, the treatment received Breakthrough Therapy Designation by the FDA for a number of indications including PBH and congenital hyperinsulinism. At the time of the announcement, Amylyx shared earlier readouts from the Phase II studies of avexitide.2
In the Phase II PREVENT study:
In the Phase IIb trial of avexitide:
1. Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025. News release. Amylyx Pharmaceuticals. July 13, 2025. Accessed July 15, 2025. https://www.businesswire.com/news/home/20250713408050/en/Amylyx-Pharmaceuticals-Presents-New-Exploratory-Analyses-from-Phase-2-and-Phase-2b-Clinical-Trials-of-Avexitide-in-Post-Bariatric-Hypoglycemia-at-ENDO-2025
2. Amylyx Pharmaceuticals Acquires Phase III-Ready GLP-1 Receptor Agonist Avexitide for Hyperinsulinemic Hypoglycemia from Eiger BioPharmaceuticals. Pharmaceutical Executive. July 12, 2024. Accessed July 15, 2025. https://www.pharmexec.com/view/amylyx-pharmaceuticals-acquires-phase-iii-ready-glp-1-receptor-agonist-avexitide-hyperinsulinemic-hypoglycemia-eiger-biopharmaceuticals
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