Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Trial ID or NCT#
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.
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
- - 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 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
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