Phase 2 N=3 Double-blind Treatment

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

Post Bariatric Hypoglycemia

Bottom Line

View on ClinicalTrials.gov: NCT02771574 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Nadir Glucose — 41; 43; 39; 42 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lyo avexitide (Drug); Liq avexitide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tracey McLaughlin
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Nadir Glucose	41; 43; 39; 42; 41; 41	—
SECONDARY Change in Composite Symptom Score as a Measure of Treatment Effect	25; 12; 22; 15; 19; 17	—
SECONDARY Pharmacokinetics of Subcutaneous Avexitide: Plasma Concentration Prior to Dosing (Co)	11; 16; 4; 71; 204	—
SECONDARY Pharmacokinetics of Subcutaneous Avexitide: Maximum Plasma Concentration (Cmax)	61; 156; 228; 331; 359	—
SECONDARY Pharmacokinetics of Subcutaneous Avexitide: Time of Maximum Plasma Concentration (Tmax)	270; 252; 240; 190; 396	—
SECONDARY Pharmacokinetics of Subcutaneous Avexitide: Area Under the Plasma Concentration Versus Time Curve (AUC)	21151; 51765; 77849; 129427; 147417	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02771574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.