Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia

What Was Tested

In this phase 4 trial, researchers set out to test Glucagon.

In the first visit, medical history and physical exam will be performed, and blood samples will be taken to assess overall health.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Visit 1 (Screening) This visit will last about 2 hours.

During the screening visit, a study team member will go over the informed consent form with you and they will help explain why this study is being done and the study procedures involved.

You will have to sign the consent form before any study related procedures take place.

These include the following: * Review medical history and medications.

Who Took Part

Enrollment: 28 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-70 years of age, inclusive, at screening. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits. Males or females diagnosed with ongoing PBH, at least 2 years following Roux-en-Y gastric bypass (RYGB), with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.

The full record lists 3 inclusion and 23 exclusion criteria; among the exclusions: documented hypoglycemia occurring only in the fasting state (\>12 hours fast);; congestive heart failure, nyha class ii, iii or iv;; history of myocardial infarction, unstable angina or revascularization within the past 6 months.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2024-11-26 with completion listed for 2026-06-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Endogenous glucose production (EGP) after administration of exogenous glucagon.

It also tracked 3 secondary outcomes, for example Insulin secretion rate in response to exogenous glucagon.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 28 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.