The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program. The safety of avexitide and patient treatment experience will be monitored during this program.
Category A: Individuals who have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.
Category B: Individuals who participated in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participants who signed ICF and were eligible for LUCIDITY based on screening and run-in, but were unable to be randomized due to completion of recruitment.
Male or female, at least 18 years of age; able to understand the purpose and risks of the program, and provides written informed consent to participate.
Not eligible for or otherwise able to obtain access to avexitide via a clinical trial, and does not have access to satisfactory, alternative treatment options.
Use of GLP-1 receptor agonists, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor dual agonists, and other GLP-1 receptor agonist combination therapies.
Presence of any clinically relevant condition which, per the judgment of the treating physician, may preclude the patient from safe treatment.
Have received another investigational drug for any indication within 5 half-lives of that drug or have participated in another interventional clinical study within 30 days prior to entry visit.
History of upper GI surgery affecting RYGB anatomy or function, other than RYGB.