Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Phase 2

Completed

• Conditions: Acquired Hyperinsulinemic Hypoglycemia
• Interventions: Drug: Avexitide

• Registration Number: NCT04652479
• Lead Sponsor: Dr. Tracey McLaughlin, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Study Start: 2021-06-21
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2023-04-10
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Results First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Avexitide 45 mg twice daily then avexitide 90 mg once daily	Avexitide	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
Avexitide 45 mg once daily then avexitide 90 mg twice daily	Avexitide	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

Primary Outcome Measures

Name	Time	Method
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Level 3 Hypoglycemia	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)	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.
Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)	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.
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)	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.
Postprandial Glycemia During Standardized Mixed Meal Consumption	3 Hours Following Standardized Liquid Meal	Change from Baseline in glycemia During Standardized Mixed Meal Consumption
Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG	Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)	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.

Trial Locations

Locations (1)

Clinical and Translational Research Unit; 🇺🇸 Palo Alto, California, United States