The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers

What Was Tested

The trial (phase 4) is built around Liraglutide.

Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1) mimetics in comparison to DPP-4 inhibitors.

It had two arms (groups): Placebo (placebo comparator) and Liraglutide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study sessions will be performed on the fourth day after placebo/liraglutide interventions.

Study sessions: On study days participants arrive at the trial centre at 8.00 am after a 12h fast.

Participants are instructed to eat a light dinner around 8.00 pm the previous day and to spend around 8h resting during the night before the study days.

Upon arrival, blood pressure and heart rate is measured and an iv line is started, from which a blood sample is taken from the antecubital vein for blood glucose, insulin and plasma hormone concentrations determination.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: Male healthy volunteers. Normal body weight (body mass index 19 -25 kg/m2). Signed informed consent. Willingness and ability to comply with the protocol.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: any history of or current drug abuse including alcohol consumption on a regular basis or binge drinking; any history of or current psychiatric disease, including any eating disorder, as assessed by structured interview; any history of dieting.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant.

It started in 2010-11 with completion listed for 2012-02.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Food intake at an ad libitum buffet (time frame: day 4). fMRI activity in the brain (time frame: day 4).

It also tracked 2 secondary outcomes, for example Changes in Ghrelin, PYY, glucose and insulin concentrations during the study session.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 16 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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