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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2019-03-15

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).

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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.

Conditions

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Postbariatric Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group 1

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

Group Type EXPERIMENTAL

exendin 9-39

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Treatment Group 2

patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)

Group Type EXPERIMENTAL

exendin 9-39

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Interventions

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exendin 9-39

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Avexitide

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No