Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

NCT04652479 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 52880
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Hyperinsulinemic Hypoglycemia

Keywords

Post Bariatric Hypoglycemia; avexitide; Post-Bariatric Hypoglycemia; Post-gastrectomy hypoglycemia; Post gastrectomy hypoglycemia; Post-esophagectomy hypoglycemia; Post esophagectomy hypoglycemia; Post-Nissen Fundoplication hypoglycemia; Post Nissen Fundoplication hypoglycemia; Exendin (9-39); Exendin 9-39

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• Rate of Level 3 Hypoglycemia

  Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

• 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)

• 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)

• Postprandial Glycemia During Standardized Mixed Meal Consumption

  3 Hours Following Standardized Liquid Meal

Study Arms (2)

Avexitide 45 mg twice daily then avexitide 90 mg once daily

EXPERIMENTAL

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 45 mg once daily then avexitide 90 mg twice daily

EXPERIMENTAL

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

Interventions

Avexitide DRUG

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

Avexitide 45 mg once daily then avexitide 90 mg twice daily; Avexitide 45 mg twice daily then avexitide 90 mg once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Tracey McLaughlin, MD: lead
• Eiger BioPharmaceuticals: collaborator

Study Sites (1)

Clinical and Translational Research Unit

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

exendin (9-39)

Results Point of Contact

• Title: Marilyn Tan, MD, FACE
• Organization: Stanford University

mjtan@stanford.edu

(650) 721-1300

Study Officials

• Marilyn Tan, MD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: December 3, 2020
• Study Start: June 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 9, 2023
• Results First Posted: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)