Liraglutide and exercise combination trial to assess weight loss maintenance and immunometabolic health

Maintaining weight loss long-term remains a significant challenge, with many individuals regaining lost weight. Current strategies often fall short in sustaining the metabolic and health benefits achieved through initial weight reduction. Obesity is a complex chronic disease associated with numerous comorbidities, and effective interventions for sustained weight management are crucial. Glucagon-like peptide-1 (GLP-1) receptor agonists like liraglutide have demonstrated efficacy in weight loss, while physical exercise is a cornerstone of healthy living. This study aims to investigate if combining these two powerful interventions can provide superior outcomes for weight loss maintenance and improve immunometabolic health.

This investigator-initiated, randomized, placebo-controlled, parallel-group trial will enroll women and men aged 18 to 65 years with obesity (BMI 32 to 43 kg/m2). Participants will first undergo an 8-week very low-calorie diet (800 kcal/day) to achieve at least 5% body weight loss. Subsequently, 4 study groups will be randomized in a 1:1:1:1 ratio for 52 weeks: 1) placebo, 2) exercise (150 min/week) + placebo, 3) liraglutide 3.0 mg/day, and 4) exercise (150 min/week) + liraglutide 3.0 mg/day. The primary endpoint is the change in body weight from randomization to the end of treatment.