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

Eiger BioPharmaceuticals18 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postbariatric Hypoglycemia

Interventions

exendin 9-39DRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

Stanford University

Palo Alto, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

Duke Early Phase Clinical Research

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Postprandial Glucose Nadir

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

Time frame: 3 hours following a liquid meal

Data from ClinicalTrials.gov

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