Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia

A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia

Lead sponsor

Eiger BioPharmaceuticals

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 IDNCT03373435

Org study IDEIG-EXD-001

Timeline

Milestones

Study first posted2017-12-14actual

Study start2018-03-19actual

Primary completion2019-01-30actual

Study completion2019-03-15actual

Results first posted2022-06-28actual

Last update posted2022-07-18actual

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior

•Diagnosis of PBH

•At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia

Exclusion criteria

•Other cause of endogenous hyperinsulinism other than PBH

•Metabolic or bariatric surgical procedure other than RYGB

•History of non-RYGB upper GI surgery

•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.