Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Completed · Phase 2

Conditions studied: Acquired Hyperinsulinemic Hypoglycemia

In brief

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.

Key facts

Study ID

NCT04652479

Run by

Dr. Tracey McLaughlin, MD

People needed

25

Starts

2021-06-21

Expected to finish

2022-06-30

Last updated by the study team

2023-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical and Translational Research Unit — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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