Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Tracey McLaughlin, MD
• Collaborator: Eiger BioPharmaceuticals

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