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Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Not Recruiting
Trial ID: NCT02771574
Purpose
This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous
exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous
formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare
disease with unmet clinical need.
Official Title
A Phase 2 Multi-Ascending Dose Trial to Assess the Efficacy, Tolerability and Pharmacokinetic Profile of Exendin (9-39) in Patients With Post-bariatric Hyperinsulinemic Hypoglycemia
Stanford Investigator(s)
Marilyn Tan
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism
Eligibility
Inclusion Criteria:
- Post-bariatric surgery more than 6 months prior to signing the informed consent
- Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms
associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or
carbohydrate administration.
- Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test
(OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant
autonomic and/or neuroglycopenic symptoms.
Exclusion Criteria:
- Patients currently using sulfonylureas or other medications that may interfere with
glucose metabolism within 5 half-lives of drug.
- Participation in any clinical investigation within 4 weeks prior to dosing
- History of or current insulinoma
- Active infection or significant acute illness within 2 weeks prior to dosing
- Female patients who are pregnant or lactating
- Women of childbearing potential and not utilizing effective contraceptive methods
- Inadequate end organ function
Intervention(s):
drug: Lyo avexitide
drug: Liq avexitide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cindy Lamendola, RN, MSN, NP
650-723-3141