Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI

What Was Tested

The trial (phase 4) is built around Liraglutide for fat loss, obesity & body recomposition.

The main purpose of this study is to help them understand the effects of diabetes medication Liraglutide on weight loss and hunger.

Liraglutide was approved by the FDA in January 2010 for treatment of diabetes.

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

The registry classes the interventions as drug.

More on the Plan

This is a randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide on brain activation in areas involved in cognitive control and reward during food visualization.

Study participation will span approximately 1.5-2 months.

Subjects will learn to self-administer the medication and will have a total of 8 study visits plus one screening visit.

The visits will include the following tests/procedures: 1.

Who Took Part

28 actual participants took part.

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

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

The full record lists 0 inclusion and 38 exclusion criteria; among the exclusions: women who are breastfeeding, pregnant, or wanting to become pregnant; women using iud; moderate, or severe hepatic impairment.

How the Study Was Run

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

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 fat loss, obesity & body recomposition participants took both Liraglutide and the comparison in turn, acting as their own control.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-03 with completion listed for 2014-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization (time frame: 18 days of Liraglutide or placebo treatment).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 28 people with fat loss, obesity & body recomposition.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research.