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.

Lead Sponsor:

Tracey McLaughlin

Collaborator: Eiger BioPharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Lyo avexitide
  • Drug: Liq avexitide

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cindy Lamendola, RN, MSN, NP
650-723-3141
Not Recruiting