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

NCT03373435 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EIG-EXD-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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).

Conditions

Postbariatric Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Postprandial Glucose Nadir

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

  3 hours following a liquid meal

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

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

Drug: exendin 9-39; Other: Placebo

Treatment Group 2

EXPERIMENTAL

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; Other: Placebo

Interventions

exendin 9-39 DRUG

Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.

Also known as: Avexitide

Treatment Group 1; Treatment Group 2

Placebo OTHER

Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.

Treatment Group 1; Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eiger BioPharmaceuticals: lead

Study Sites (5)

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke Early Phase Clinical Research

Durham, North Carolina, 27710, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related 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. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103.

  PMID: 33616643 RESULT

MeSH Terms

Interventions

exendin (9-39)

Results Point of Contact

• Title: Senior VP, Clinical Development
• Organization: Eiger BioPharmaceuticals, Inc.

info@eigerbio.com

1-650-272-6138

Study Officials

• Colleen Craig, MD

  Eiger BioPharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 14, 2017
• Study Start: March 19, 2018
• Primary Completion: January 30, 2019
• Study Completion: March 15, 2019
• Last Updated: July 18, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)