NCT03347890: LIRAOB

Reward Mechanisms in Obesity

Completed Phase 4 Last updated 30 April 2021

What this trial tests

Phase 4 trial testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo in Obesity in 70 participants. Completed in 30 March 2020.

Timeline

5 March 2018

Primary endpoint
18 March 2020

30 March 2020

Quick facts

Lead sponsor	Zoltan Pataky
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	5 March 2018
Primary completion	18 March 2020
Estimated completion	30 March 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Zoltan Pataky — full company profile →

Who can join

Adults 18 to 75, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes).

According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.

All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli. Second, participants will complete behavioural tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated with food intake. Third, metabolic parameters and hormones involved in appetite regulation will be assessed and studied in relation to fMRI.

These measurements will be repeated after 16 weeks in obese individuals. The control group of normal body weight individuals will be evaluated once at Baseline.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized controlled trial investigating the effect of liraglutide on self-reported liking and neural responses to food stimuli in participants with obesity.
   Coppin G, Muñoz Tord D, Pool ER, Locatelli L, et al · · 2023 · cited 10× · PMID 37626125 · DOI 10.1038/s41366-023-01370-w
2. 3D-Printed Pacifier-Shaped Mouthpiece for fMRI-Compatible Gustometers.
   Munoz Tord D, Coppin G, Pool ER, Mermoud C, et al · · 2021 · cited 3× · PMID 34551958 · DOI 10.1523/eneuro.0208-21.2021
3. Does GLP-1 receptor agonist liraglutide alter food-related sensory pleasure in patients with obesity? A randomized controlled trial
   Coppin G, David MT, Pool E, Locatelli L, et al · · 2022 · DOI 10.21203/rs.3.rs-1722974/v1