Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Acquired Hyperinsulinemic Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652479
• Other study ID #: 52880
• Status: Completed
• Phase: Phase 2
• Start date: June 21, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Hyperinsulinemic Hypoglycemia
• Congenital Hyperinsulinism
• Hypoglycemia
• Nesidioblastosis

Intervention

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

Locations

Country	Name	City	State
United States	Clinical and Translational Research Unit	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Tracey McLaughlin, MD	Eiger BioPharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)	Level 2 hypoglycemia events (ADA, <54 mg/dL) as measured by CGM and defined as the number of events captured by CGM with glucose measures <54 mg/dL during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary	Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG	Distinct episodes of Level 2 hypoglycemia (SMBG glucose <54 mg/dL), divided by number of days for run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary	Rate of Level 3 Hypoglycemia	Severe events during each treatment period characterized by altered mental and/or physical functioning that requires assistance from another person for recovery; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. This would apply regardless of whether a patient actually received external assistance.	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary	Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)	Percentage of time in level 2 hypoglycemia (<54mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary	Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)	Percentage of time in level 1 hypoglycemia (<70mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary	Postprandial Glycemia During Standardized Mixed Meal Consumption	Change from Baseline in glycemia During Standardized Mixed Meal Consumption	3 Hours Following Standardized Liquid Meal