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

Completed · Phase 2 · Has a placebo group

Conditions studied: Postbariatric Hypoglycemia

In brief

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).

Key facts

Study ID

NCT03373435

Run by

Eiger BioPharmaceuticals

People needed

18

Starts

2018-03-19

Expected to finish

2019-03-15

Last updated by the study team

2022-07-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Duke Early Phase Clinical Research — Durham, North Carolina, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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