[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639974":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":34,"collaborators":7,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":7,"eligibilityCriteria":41,"healthyVolunteers":38,"sex":42,"minAge":43,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":44,"phases":7,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Amylyx Pharmaceuticals Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Avexitide","90 mg subcutaneous injection once per day at least one hour prior to first meal of the day.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Medical Director, Amylyx Pharmaceuticals","CONTACT","1-857-575-7007","MedInfo@amylyx.com",[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"Diabetes and Glandular Disease Clinic","AVAILABLE","San Antonio","Texas","78229-4801","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-98.49363,29.42412,{"lat":32,"lon":31},{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100639974","an-expanded-access-protocol-to-provide-avexitide-in-patients-with-post-bariatric-hypoglycemia-100639974",false,"NCT07582874","An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia","Patients in this EAP will be eligible in one of two categories (Category A and Category B) as defined below:\n\n* Category A: Individuals who have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.\n* 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.\n\nKey Inclusion Criteria:\n\nApplicable to all patients:\n\n* 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.\n* 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.\n* If female, cannot be breastfeeding or lactating, and if of childbearing potential must agree to use a highly effective method of birth control during EAP participation. A negative urine pregnancy test is required at time of entry.\n* If male, must agree to use a highly effective method of birth control during EAP participation.\n\nFor Category A:\n\n* Have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.\n\nFor Category B:\n\n* Have clinical diagnosis of PBH, and underwent documented RYGB ≥ 12 months prior to EAP eligibility assessment.\n* Has body mass index (BMI) of up to 40 kg\u002Fm2.\n* Treating physician confirmation of either participation in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participant who signed ICF and was eligible for LUCIDITY based on screening and run-in, but was unable to be randomized due to completion of recruitment.\n\nKey Exclusion Criteria:\n\nApplicable to all patients:\n\n* Use of GLP-1 receptor agonists, glucose-dependent insulinotropic polypeptide (GIP)\u002FGLP-1 receptor dual agonists, and other GLP-1 receptor agonist combination therapies.\n* Presence of any clinically relevant condition which, per the judgment of the treating physician, may preclude the patient from safe treatment.\n\nFor Category B:\n\n* 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.\n* History of upper GI surgery affecting RYGB anatomy or function, other than RYGB.\n* Any known or suspected allergy to the investigational medicinal product (avexitide) or any related product (e.g., exenatide).\n* Abnormal liver function defined as AST and\u002For ALT \\> 5 times the upper limit of the normal and\u002For bilirubin level \\>3 times the upper limit of the normal within 12 weeks from entry.\n* Renal impairment, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 within 12 weeks from entry.\n* History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH.\n* Presence of acute or chronic pancreatitis, history of idiopathic acute pancreatitis, or pancreatic cancer.","ALL","18 Years","EXPANDED_ACCESS","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.",[47],"Post-bariatric Hypoglycemia",[49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"AVX","avexitide","PBH","post-bariatric hypoglycemia","hypoglycemia post bariatric surgery","reactive hypoglycemia","hypoglycemia","low blood sugar","Roux-en-Y gastric bypass (RYGB)","Roux-en-Y gastric bypass","Roux-en-Y","RYGB","gastric bypass","LUCIDITY","PREVENT","exendin","exendin 9-39","exendin 939","2026-05-05",{"date":69,"type":70},"2026-05-13","ACTUAL",{"name":5,"class":6},1]