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

• Status: Completed
• Trial end date: 2018-10-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eiger BioPharmaceuticals
• Treatments: Glucagon; Glucagon-Like Peptide 1

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