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

Eiger BioPharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Postbariatric Hypoglycemia

Treatments: Drug: exendin 9-39; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03373435

EIG-EXD-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Treatment Group 1

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: exendin 9-39

Treatment Group 2

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: exendin 9-39