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

NCT07582874 | Unknown

• 1 other identifier: AVX-002
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-bariatric Hypoglycemia

Keywords

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

Interventions

Avexitide DRUG

90 mg subcutaneous injection once per day at least one hour prior to first meal of the day.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amylyx Pharmaceuticals Inc.: lead

Study Sites (1)

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229-4801, United States

AVAILABLE

MeSH Terms

Conditions

Hypoglycemia

Interventions

exendin (9-39)

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Medical Director, Amylyx Pharmaceuticals

CONTACT

1-857-575-7007; MedInfo@amylyx.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 13, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)