CompletedPhase 1, PHASE2Results posted

Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

Role of GLP-1 in Congenital Hyperinsulinism:Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

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 IDNCT00897676

Org study ID2008-10-6255

Secondary IDR01FD004905US Food and Drug Administration

Timeline

Milestones

Study first posted2009-05-12estimated

Primary completion2016-08-26actual

Results first posted2018-01-18actual

Last update posted2020-03-13actual

Study start2009-05 (month precision)

Study completion2017-01actual (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age6 Months

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Confirmed diagnosis of hyperinsulinism

•Mutation analysis results demonstrating KATP channel defect

•Age 6 months to 18 years with

•Persistent hypoglycemia

Exclusion criteria

•Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1

•Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure

•Pregnancy

•Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test

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.