Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
NCT ID: NCT04652479
Last Updated: 2023-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2021-06-21
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Avexitide 45 mg twice daily then avexitide 90 mg once daily
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
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
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
Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
Interventions
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Avexitide
Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
Eligibility Criteria
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Inclusion Criteria
* 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
* History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia).
* Use of agents that may interfere with glucose metabolism
18 Years
ALL
No
Sponsors
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Eiger BioPharmaceuticals
INDUSTRY
Dr. Tracey McLaughlin, MD
OTHER
Responsible Party
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Marilyn Tan
Clinical Assistant Professor of Medicine
Principal Investigators
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Marilyn Tan, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Clinical and Translational Research Unit
Palo Alto, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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52880
Identifier Type: -
Identifier Source: org_study_id
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