Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Dr. Tracey McLaughlin, MD

Status and phase: Completed; Phase 2

Conditions: Acquired Hyperinsulinemic Hypoglycemia

Treatments: Drug: Avexitide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04652479

52880

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Avexitide 45 mg twice daily then avexitide 90 mg once daily

Experimental group

Description:

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

Treatment:

Drug: Avexitide

Avexitide 45 mg once daily then avexitide 90 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: Avexitide