- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373435
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia (PREVENT)
A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.
Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.
Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University
-
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Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado, Denver
-
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Early Phase Clinical Research
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) of up to 40 kg/m2
- Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
- Diagnosis of PBH
- At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia
Exclusion Criteria:
- Other cause of endogenous hyperinsulinism other than PBH
- Metabolic or bariatric surgical procedure other than RYGB
- History of non-RYGB upper GI surgery
- Use of agents that may interfere with glucose metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment Group 1
patients will receive two dose regimens of exendin 9-39 and one placebo
|
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Other Names:
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
|
EXPERIMENTAL: Treatment Group 2
patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
|
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Other Names:
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial Glucose Nadir
Time Frame: 3 hours following a liquid meal
|
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
|
3 hours following a liquid meal
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Colleen Craig, MD, Eiger BioPharmaceuticals, Inc
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIG-EXD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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