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

Primary Purpose

Postbariatric Hypoglycemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
exendin 9-39
Placebo
Sponsored by
Eiger BioPharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postbariatric Hypoglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University of Colorado, Denver
  • Johns Hopkins University
  • Duke Early Phase Clinical Research
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Group 1

Treatment Group 2

Arm Description

patients will receive two dose regimens of exendin 9-39 and one placebo

patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)

Outcomes

Primary Outcome Measures

Postprandial Glucose Nadir
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)

Secondary Outcome Measures

Full Information

First Posted
November 27, 2017
Last Updated
June 30, 2022
Sponsor
Eiger BioPharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03373435
Brief Title
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eiger BioPharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postbariatric Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
patients will receive two dose regimens of exendin 9-39 and one placebo
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Description
patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
Intervention Type
Drug
Intervention Name(s)
exendin 9-39
Other Intervention Name(s)
Avexitide
Intervention Description
Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
Primary Outcome Measure Information:
Title
Postprandial Glucose Nadir
Description
Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)
Time Frame
3 hours following a liquid meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Craig, MD
Organizational Affiliation
Eiger BioPharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Duke Early Phase Clinical Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33616643
Citation
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. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103.
Results Reference
result

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

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