Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Sponsor

Dr. Tracey McLaughlin, MD (Other)

Overall Status

Completed

CT.gov ID

NCT04652479

Collaborator

Eiger BioPharmaceuticals (Industry)

Enrollment

Location

Arms

12.3

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acquired Hyperinsulinemic Hypoglycemia	Drug: Avexitide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia

Actual Study Start Date :

Jun 21, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1 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	Drug: Avexitide Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
Experimental: Treatment Group 2 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 (in the opposite sequence from Treatment Group 1)	Drug: Avexitide Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor

Arm

Intervention/Treatment

Experimental: Treatment Group 1

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

Drug: Avexitide

Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor

Experimental: Treatment Group 2

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 (in the opposite sequence from Treatment Group 1)

Drug: Avexitide

Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor

Outcome Measures

Primary Outcome Measures

Number of diurnal Level 2 hypoglycemia events (ADA, <54 mg/dL) as measured by CGM in patients with severe HH [14 Days]
Change from Baseline in Rate of Level 2 Hypoglycemia measured by CGM

Secondary Outcome Measures

Rate of Level 2 hypoglycemia (ADA, <54 mg/dL) as measured by SMBG [14 Days]
Change from Baseline in Rate of Level 2 Hypoglycemia
Rate of Level 3 Hypoglycemia [14 Days]
Change from Baseline in Rate of Level 3 Hypoglycemia (Severe Hypoglycemia)
Percent diurnal time <54 mg/dL as measured by CGM [14 Days]
Change from Baseline in Percent diurnal time with Clinically Important Hypoglycemia (< 54mg/dL by Continuous Glucose Monitor)
Postprandial glycemia during standardized mixed meal consumption [3 Hours Following Standardized Liquid Meal]
Change from Baseline in glycemia During Standardized Mixed Meal Consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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