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OpenTrials
Completed

NCT Number: NCT04652479

Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

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.

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Key information

Conditions

Acquired Hyperinsulinemic Hypoglycemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical and Translational Research Unit

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avexitide

Drug

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

Primary outcomes

  1. Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)

    Time frame: 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 outcomes

  1. Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG

    Time frame: 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.

  2. Rate of Level 3 Hypoglycemia

    Time frame: 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.

  3. Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)

    Time frame: 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.

  4. Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)

    Time frame: 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.

  5. Postprandial Glycemia During Standardized Mixed Meal Consumption

    Time frame: 3 Hours Following Standardized Liquid Meal

    Change from Baseline in glycemia During Standardized Mixed Meal Consumption

Sponsors and collaborators

Lead sponsor

Dr. Tracey McLaughlin, MD

Other

Collaborators

  • Eiger BioPharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.