Status:
COMPLETED
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Lead Sponsor:
Eiger BioPharmaceuticals
Conditions:
Postbariatric Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
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 tw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03373435
Start Date
March 19 2018
End Date
March 15 2019
Last Update
July 18 2022
Active Locations (5)
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1
Stanford University
Palo Alto, California, United States, 94304
2
University of Colorado, Denver
Aurora, Colorado, United States, 80045
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
4
Duke Early Phase Clinical Research
Durham, North Carolina, United States, 27710