Study of CONTRAVE and Diet Effects on Brain, Metabolism, and Behavior in Adults with Obesity Aged 18 to 64

What this Trial Is About

Researchers are studying adults aged 18 to 64 with obesity to understand how the drug CONTRAVE40 affects weight loss mechanisms. This study compares CONTRAVE40 plus a diet program against a placebo plus the same diet program. The aim is to explore how CONTRAVE40 influences mood, body composition, metabolism, brain activity, appetite, cravings, and behavioral factors related to obesity. Participants will be randomly assigned to two groups one receiving CONTRAVE40 and the other a placebo, both alongside a 4-week individualized diet program from a registered dietitian. The drug dose is gradually increased to a therapeutic level over four weeks. The study involves five in-person visits for screening, baseline testing, intervention, and follow-up. Participants will take their assigned pills twice daily and engage in weekly diet coaching. Daily online monitoring of medication adherence and side effects will occur during the intervention. Participants will complete assessments at baseline and after four weeks, including body composition, resting energy expenditure, food preferences, cognitive tests, brain scans EEG and MRI, and questionnaires on mood and behavior. Safety and side effects will be regularly monitored. The study will measure changes in brain activity related to food impulsivity and reward, body weight and composition, and metabolic and mood effects. Total participation includes screening, baseline visits, a 4-week treatment period, and post-intervention testing.

Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity