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

June 30, 2022 updated by: Eiger BioPharmaceuticals

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).

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Denver
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Early Phase Clinical Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group 1
patients will receive two dose regimens of exendin 9-39 and one placebo
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Other Names:
  • Avexitide
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
EXPERIMENTAL: Treatment Group 2
patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Other Names:
  • Avexitide
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial Glucose Nadir
Time Frame: 3 hours following a liquid meal
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
3 hours following a liquid meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Colleen Craig, MD, Eiger BioPharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 19, 2018

Primary Completion (ACTUAL)

January 30, 2019

Study Completion (ACTUAL)

March 15, 2019

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (ACTUAL)

December 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • EIG-EXD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postbariatric Hypoglycemia

Clinical Trials on exendin 9-39

3
Subscribe