Reward Mechanisms in Obesity

What Was Tested

The trial (phase 4) is built around Liraglutide.

All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli.

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

35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector.

The registry classes the interventions as drug.

Who Took Part

70 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: BMI ≥ 30 kg/m2 and \< 40 kg/m2.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: history of any psychiatric, neurological, cardiovascular, renal or liver disease, malignancies, type 1 and type 2 diabetes mellitus; use of centrally acting medication, glucocorticoides, insulin, orlistat; any substance abuse.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-03-05 with completion listed for 2020-03-18.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system (time frame: 16 weeks).

It also tracked 15 secondary outcomes, for example change of body weight, changes in waist circumference, changes in fasting blood sugar, changes in glucagon, changes in ghrelin and changes in leptin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 70 people.

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.