Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

Not Recruiting

Trial ID: NCT02771574


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
Marilyn Tan

Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism


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


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