Trial Search Results
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
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.
Stanford is currently not accepting patients for this trial.
Collaborator: Eiger BioPharmaceuticals
- Drug: Lyo avexitide
- Drug: Liq avexitide
- 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
- 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.
- 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
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study