Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Trial ID or NCT#
NCT03373435
Status
NOT RECRUITING
Purpose
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).
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Marilyn Tan
Endocrinologist
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism
Contact us to find out if this trial is right for you.
Contact
Aileen Muno
(650) 725-9890
View on ClinicalTrials.gov
