NCT03373435

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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 two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection. Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.

Conditions

• Postbariatric Hypoglycemia

Interventions

Type	Name	Description
DRUG	exendin 9-39	Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
OTHER	Placebo	Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.

Timeline

• Start date: 2018-03-19
• Primary completion: 2019-01-30
• Completion: 2019-03-15
• First posted: 2017-12-14
• Last updated: 2022-07-18
• Results posted: 2022-06-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study