Intranasal Glucagon and Energy Balance

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Glucagon.

Based on studies in animals, it does so by working on the brain.

It had two arms (groups): Glucagon (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Resting energy expenditure, appetite and food intake is being investigated in up to 20 individuals.

Participants are their own control in a single-blind, placebo-controlled, crossover design.

Study visits occur 1-3 weeks apart with intranasal glucagon or placebo applied in random order.

Resting energy expenditure is measured via indirect calorimetry at baseline and over 90 minutes post-spray in 10-20 minute segments.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Body mass index 25- 40 kg/m2. Hemoglobin in the normal range. Normal fasting glucose and HbA1C. Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 1 month prior to and after the study.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: study participant with active hepatic disease (except hepatic steatosis which is frequently seen in overweight/obese individuals); any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis; any current or previous history of malignancy.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-06-06 with completion listed for 2018-09-30.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Energy Expenditure (time frame: 90 minutes).

It also tracked 2 secondary outcomes, for example Food intake and Appetite.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Glucagon in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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