ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03373435
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Eiger BioPharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Postbariatric Hypoglycemia Drug: exendin 9-39 Other: Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Treatment Group 1
patients will receive two dose regimens of exendin 9-39 and one placebo
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.

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)
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.




Primary Outcome Measures :
  1. Postprandial Hypoglycemia [ Time Frame: 3 hours following a liquid meal ]
    Plasma glucose nadir occurring within 3 hours of MMTT

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Postprandial hyperinsulinemia. [ Time Frame: 3 hours following a liquid meal ]
    Peak postprandial insulin concentration in response to MMTT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373435


Contacts
Contact: Teresa Joshi, RN 714-651-4910 tjoshi@eigerbio.com

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Aileen Muno       munoai@stanford.edu   
Contact: Marilyn Tan, MD       mjtan@stanford.edu   
Principal Investigator: Marilyn Tan, MD         
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Helen Lawler, MD    720-848-5146    Endo.ClinicalTrials@ucdenver.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dezeray Cephas    443-507-8222    dcephas1@jhu.edu   
Principal Investigator: Clare Lee, MD, MHS         
United States, North Carolina
Duke Early Phase Clinical Research Recruiting
Durham, North Carolina, United States, 27710
Contact    919-613-6246    DCRIvolunteer@duke.edu   
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Constance B Trantow    608-265-7814      
Sponsors and Collaborators
Eiger BioPharmaceuticals
Investigators
Study Director: Colleen Craig, MD Eiger BioPharmaceuticals, Inc

Responsible Party: Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier: NCT03373435     History of Changes
Other Study ID Numbers: EIG-EXD-001
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents