An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia

An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia

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.

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/m2.
• 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.

Key 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.