CompletedPhase 1

Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia

Subcutaneous Injection of Exendin (9-39) in Subjects With Hyperinsulinemic Hypoglycemia Post-Bariatric Surgery

Lead sponsor

Tracey McLaughlin

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02996812

Org study ID34054

Timeline

Milestones

Study first posted2016-12-19estimated

Last update posted2024-12-04actual

Study start2015-04actual (month precision)

Primary completion2016-08actual (month precision)

Study completion2016-08actual (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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 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.

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

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.