CompletedPhase 2

Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia

United States18 participantsStarted 2018-03-19

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Postprandial Glucose Nadir

Timeframe: 3 hours following a liquid meal

Trial details

NCT IDNCT03373435

SponsorEiger BioPharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-30

Results submitted2022-05-17

View on ClinicalTrials.gov More Postbariatric Hypoglycemia trials