CompletedPhase 2Results posted

Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia

Lead sponsor

Dr. Tracey McLaughlin, MD

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

•BMI ≤40

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 IDNCT04652479

Org study ID52880

Timeline

Milestones

Study first posted2020-12-03actual

Study start2021-06-21actual

Primary completion2022-06-30actual

Study completion2022-06-30actual

Last update posted2023-06-09actual

Results first posted2023-06-09actual

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening

•History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record.

•Body mass index (BMI) of up to 40 kg/m2

•If female, must not be breastfeeding and must have a negative urine pregnancy test result

Exclusion criteria

•Major surgery within 6 months before randomization.

•History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia).

•Use of agents that may interfere with glucose metabolism

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.