Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Trial ID or NCT#

NCT04652479

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Marilyn Tan
Marilyn Tan
Endocrinologist
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism

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Contact

Termeh Shamloo
650-721-1300

View on ClinicalTrials.gov