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

Phase 2

Completed

• Conditions: Postbariatric Hypoglycemia
• Interventions: Drug: exendin 9-39; Other: Placebo

• Registration Number: NCT03373435
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-14
• Study Start: 2018-03-19
• Primary Completion: 2019-01-30
• Study Completion: 2019-03-15
• Disposition First Submitted: 2020-01-27
• Results First Submitted: 2022-05-17
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-20
• Disposition First Submitted QC: 2022-06-20
• Results First Posted: 2022-06-28
• Disposition First Posted: 2022-06-28
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	exendin 9-39	patients will receive two dose regimens of exendin 9-39 and one placebo
Treatment Group 1	Placebo	patients will receive two dose regimens of exendin 9-39 and one placebo
Treatment Group 2	exendin 9-39	patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)
Treatment Group 2	Placebo	patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)

Primary Outcome Measures

Name	Time	Method
Postprandial Glucose Nadir	3 hours following a liquid meal	Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)

Trial Locations

Locations (5)

Stanford University; 🇺🇸 Palo Alto, California, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Duke Early Phase Clinical Research; 🇺🇸 Durham, North Carolina, United States

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States