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Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Recruiting
I'm InterestedTrial ID: NCT04652479
Purpose
The primary goal of this study is to evaluate the safety and efficacy of two different dosing
regimens of an investigational drug called Avexitide in treating low blood sugar in patients
with Acquired Hyperinsulinemic Hypoglycemia.
Official Title
A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia
Stanford Investigator(s)
Marilyn Tan
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism
Eligibility
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
Intervention(s):
drug: Avexitide
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Termeh Shamloo
650-721-1300