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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373435
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE March 19, 2018
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Postprandial Hypoglycemia [ Time Frame: 3 hours following a liquid meal ]
    Plasma glucose nadir occurring within 3 hours of MMTT
  • Incidence of treatment-emergent adverse events [ Time Frame: 6 weeks ]
    An adverse event can be any unfavorable and unintended sign, symptom, or disease that occurs during the study treatment periods.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Severity score of postprandial neuroglycopenic signs and symptoms calculated from patients' responses to the Edinburgh Hypoglycemia Symptom Scale. (EHSS). [ Time Frame: 3 hours following a liquid meal ]
    Neuroglycopenic symptoms evaluated by the EHSS include blurred vision, confusion, drowsiness, speech difficulty, incoordination, dizziness, and inability to concentrate. Patients will complete the EHSS approximately every 30 minutes during each MMTT.
  • Postprandial hyperinsulinemia. [ Time Frame: 3 hours following a liquid meal ]
    Peak postprandial insulin concentration in response to MMTT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Postbariatric Hypoglycemia
Intervention  ICMJE
  • Drug: exendin 9-39
    Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
    Other Name: Glucagon-like peptide-1 (GLP-1) antagonist
  • Other: Placebo
    Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
Study Arms  ICMJE
  • Experimental: Treatment Group 1
    patients will receive two dose regimens of exendin 9-39 and one placebo
    Interventions:
    • Drug: exendin 9-39
    • Other: Placebo
  • 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)
    Interventions:
    • Drug: exendin 9-39
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2019)
18
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
20
Actual Study Completion Date  ICMJE October 15, 2018
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03373435
Other Study ID Numbers  ICMJE EIG-EXD-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eiger BioPharmaceuticals
Study Sponsor  ICMJE Eiger BioPharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Colleen Craig, MD Eiger BioPharmaceuticals, Inc
PRS Account Eiger BioPharmaceuticals
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP