drugset / Trial / NCT03795701

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

NCT03795701

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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. The study will consist of a 4-week partial dose period (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg) period. The placebo group will administer equivalent volumes of the pre-filled solutions from pen-injector at the same time, using the same method during this period. The study proposes to identify factors contributing to early weight loss response in a Saxenda® treatment program. Specifically, the proposed experiments will help determine if Saxenda® changes brain functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the magnitude of that change is associated with changes in behavioral and physiological variables (hunger, satiety, cravings and weight loss).

Timeline

Start
2019-01-08
Primary completion
2022-05-01
Completion
2022-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 3 mg

Indications