NCT07582874AvailableNot Applicable
An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Available
- Sponsor
- Amylyx Pharmaceuticals Inc.
- Locations
- 4
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients in this EAP will be eligible in one of two categories (Category A and Category B) as defined below:
- •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.
- •Key Inclusion Criteria:
- •Applicable to all patients:
- •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.
- •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.
- •If male, must agree to use a highly effective method of birth control during EAP participation.
- •For Category A:
- •Have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.
- •For Category B:
- •Have clinical diagnosis of PBH, and underwent documented RYGB ≥ 12 months prior to EAP eligibility assessment.
- •Has body mass index (BMI) of up to 40 kg/m
- •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.
Exclusion Criteria
- •Applicable to all patients:
- •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.
- •For Category B:
- •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.
- •Any known or suspected allergy to the investigational medicinal product (avexitide) or any related product (e.g., exenatide).
- •Abnormal liver function defined as AST and/or ALT > 5 times the upper limit of the normal and/or bilirubin level >3 times the upper limit of the normal within 12 weeks from entry.
- •Renal impairment, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 within 12 weeks from entry.
- •History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH.
- •Presence of acute or chronic pancreatitis, history of idiopathic acute pancreatitis, or pancreatic cancer.
Investigators
Study Sites (4)
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