Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia (PREVENT)
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| ClinicalTrials.gov Identifier: NCT03373435 |
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Recruitment Status :
Recruiting
First Posted : December 14, 2017
Last Update Posted : July 31, 2018
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Sponsor:
Eiger BioPharmaceuticals
Information provided by (Responsible Party):
Eiger BioPharmaceuticals
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Brief Summary:
This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postbariatric Hypoglycemia | Drug: exendin 9-39 Other: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 19, 2018 |
| Estimated Primary Completion Date : | October 2018 |
| Estimated Study Completion Date : | October 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hypoglycemia
Drug Information available for:
Glucagon
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Group 1
patients will receive two dose regimens of exendin 9-39 and one placebo
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Drug: exendin 9-39
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Other Name: Glucagon-like peptide-1 (GLP-1) antagonist Other: Placebo Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
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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)
|
Drug: exendin 9-39
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Other Name: Glucagon-like peptide-1 (GLP-1) antagonist Other: Placebo Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39. |
Primary Outcome Measures :
- Postprandial Hypoglycemia [ Time Frame: 3 hours following a liquid meal ]Plasma glucose nadir occurring within 3 hours of MMTT
- Incidence of treatment-emergent adverse events [ Time Frame: 6 weeks ]An adverse event can be any unfavorable and unintended sign, symptom, or disease that occurs during the study treatment periods.
Secondary Outcome Measures :
- Severity score of postprandial neuroglycopenic signs and symptoms calculated from patients' responses to the Edinburgh Hypoglycemia Symptom Scale. (EHSS). [ Time Frame: 3 hours following a liquid meal ]Neuroglycopenic symptoms evaluated by the EHSS include blurred vision, confusion, drowsiness, speech difficulty, incoordination, dizziness, and inability to concentrate. Patients will complete the EHSS approximately every 30 minutes during each MMTT.
- Postprandial hyperinsulinemia. [ Time Frame: 3 hours following a liquid meal ]Peak postprandial insulin concentration in response to MMTT
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373435
Contacts
| Contact: Teresa Joshi, RN | 714-651-4910 | tjoshi@eigerbio.com |
Locations
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Aileen Muno munoai@stanford.edu | |
| Contact: Marilyn Tan, MD mjtan@stanford.edu | |
| Principal Investigator: Marilyn Tan, MD | |
| United States, Colorado | |
| University of Colorado, Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Helen Lawler, MD 720-848-5146 Endo.ClinicalTrials@ucdenver.edu | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Dezeray Cephas 443-507-8222 dcephas1@jhu.edu | |
| Principal Investigator: Clare Lee, MD, MHS | |
| United States, North Carolina | |
| Duke Early Phase Clinical Research | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact 919-613-6246 DCRIvolunteer@duke.edu | |
| United States, Wisconsin | |
| University of Wisconsin | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Constance B Trantow 608-265-7814 | |
Sponsors and Collaborators
Eiger BioPharmaceuticals
Investigators
| Study Director: | Colleen Craig, MD | Eiger BioPharmaceuticals, Inc |
| Responsible Party: | Eiger BioPharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03373435 History of Changes |
| Other Study ID Numbers: |
EIG-EXD-001 |
| First Posted: | December 14, 2017 Key Record Dates |
| Last Update Posted: | July 31, 2018 |
| Last Verified: | July 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Glucagon-Like Peptide 1 Glucagon |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Gastrointestinal Agents |