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Completed

NCT Number: NCT03373435

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

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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Key information

Conditions

Postbariatric Hypoglycemia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exendin 9-39

Drug

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

Other names: Avexitide

Placebo

Other

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

Primary outcomes

  1. Postprandial Glucose Nadir

    Time frame: 3 hours following a liquid meal

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

Sponsors and collaborators

Lead sponsor

Eiger BioPharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2017
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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