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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postbariatric Hypoglycemia

Intervention / Treatment
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* Drug: exendin 9-39
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>patients will receive two dose regimens of exendin 9-39 and one placebo | Drug: exendin 9-39<br>* Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.<br>* Other names: Avexitide;Other: Placebo<br>* Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.<br>|
| Experimental: Treatment Group 2<br>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<br>* Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.<br>* Other names: Avexitide;Other: Placebo<br>* Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glucose Nadir | Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT) | 3 hours following a liquid meal |