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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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


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

Contact us to find out if this trial is right for you.


Cindy Lamendola, RN, MSN, NP