Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Glucagon.

It had three arms (groups): one (active comparator), one (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 18-55 years, inclusive. Body Mass Index (BMI) ≥27 to ≤45 kg/m2 and body weight \<450 lbs. Judged to be non-diabetic per the American Diabetes Association guidelines:. In good health on the basis of medical history, physical examination (PE), electrocardiogram (ECG), and normal laboratory values obtained from Screening visit labs. Understands the procedures and agrees to participate in the study program by giving written informed consent, and is willing to comply with the trial restrictions.

The full record lists 11 inclusion and 24 exclusion criteria; among the exclusions: treatment with a selective serotonin reuptake inhibitor, a medication for depression or apomorphine within one week prior to screening due to interaction with zofran; history of bariatric surgery; history of irritable bowel disease, recurrent nausea, or vomiting.

How the Study Was Run

It was run as a non-randomized, parallel-group and single-blind study.

The Glucagon group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant.

It started in 2017-10-24 with completion listed for 2018-02-14.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Energy Expenditure (time frame: 24 hours). Effects of continuous IV infusion of glucagon versus placebo (time frame: 72 hours).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Glucagon in 30 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.