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

Postbariatric Hypoglycemia Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373435
• Other study ID #: EIG-EXD-001
• Status: Completed
• Phase: Phase 2
• Start date: March 19, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: June 2022
• Source: Eiger BioPharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 15, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Postbariatric Hypoglycemia

Intervention

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.

Locations

Country	Name	City	State
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	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Eiger BioPharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Craig CM, Lawler HM, Lee CJE, Tan M, Davis DB, Tong J, Glodowski M, Rogowitz E, Karaman R, McLaughlin TL, Porter L. PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia. J Clin Endocrinol Metab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Glucose Nadir	Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)	3 hours following a liquid meal