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

Status:	Completed
Conditions:	Endocrine
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 65
Updated:	2/13/2019
Start Date:	March 19, 2018
End Date:	October 15, 2018

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

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).

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.

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

We found this trial at

sites

Duke Early Phase Clinical Research

2400 Pratt Street
Durham, North Carolina 27710

Phone: 919-613-6246

2199

from 91732

Durham, NC