Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Acquired Hyperinsulinemic Hypoglycemia
About this trial
This is an interventional treatment trial for Acquired Hyperinsulinemic Hypoglycemia focused on measuring Post Bariatric Hypoglycemia, avexitide, Post-Bariatric Hypoglycemia, Post-gastrectomy hypoglycemia, Post gastrectomy hypoglycemia, Post-esophagectomy hypoglycemia, Post esophagectomy hypoglycemia, Post-Nissen Fundoplication hypoglycemia, Post Nissen Fundoplication hypoglycemia, Exendin (9-39), Exendin 9-39
Eligibility Criteria
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
Sites / Locations
- Clinical and Translational Research Unit
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Avexitide 45 mg twice daily then avexitide 90 mg once daily
Avexitide 45 mg once daily then avexitide 90 mg twice daily
Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days
Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days