To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity

What Was Tested

This registered not phased trial tested Liraglutide for fat loss, obesity & body recomposition.

The study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design.

Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments.

It had two arms (groups): Placebo (placebo comparator) and Liraglutide 3.0 (experimental).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 73 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age 18-60 years. BMI 30-50 kg/m2.

The full record lists 2 inclusion and 33 exclusion criteria; among the exclusions: participants unable or unwilling to provide informed consent; participants with motor, visual or hearing impairment; females with irregular menstrual cycles (onset of menstruation greater than 1 week from expected data during the last 3 months).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Liraglutide.

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

It started in 2019-01-08 with completion listed for 2022-05-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Compare the changes of pre-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group (time frame: Baseline, Week 4, and Week 16). Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group (time frame: Baseline, Week 4, and Week 16). Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group (time frame: Baseline, Week 4, and Week 16).

It also tracked 15 secondary outcomes, for example Correlation between changes in post-prandial fMRI-FCR and changes in energy intake, Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety, Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety, Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety, Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety and Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 73 people with fat loss, obesity & body recomposition.

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

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