CompletedPhase 1, PHASE2Results posted

Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

An Open Label Pilot Study of the Effects of the Glucagon-like Peptide-1 Receptor Antagonist, Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

Lead sponsor

Diva De Leon

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 IDNCT00571324

Org study ID2007-1-5131

Secondary IDR03DK078535-01

Timeline

Milestones

Study first posted2007-12-12estimated

Results first posted2016-11-09estimated

Last update posted2017-12-11actual

Study start2007-08 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age7 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with congenital hyperinsulinism

Exclusion criteria

•Acute medical illness

•History of other systemic chronic disease such as cardiac failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension

•Pregnancy

•Diabetes mellitus

•Use of medications that affect glucose metabolism, such as glucocorticoids, beta agonists, diazoxide and octreotide.

•Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hrs after last dose of diazoxide

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 tableClinicalTrials.gov results section

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.