TY - JOUR T1 - Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2019-031431 VL - 9 IS - 11 SP - e031431 AU - Simon Birk Kjær Jensen AU - Julie Rehné Lundgren AU - Charlotte Janus AU - Christian Rimer Juhl AU - Lisa Møller Olsen AU - Mads Rosenkilde AU - Jens Juul Holst AU - Bente Merete Stallknecht AU - Sten Madsbad AU - Signe Sørensen Torekov Y1 - 2019/11/01 UR - http://bmjopen.bmj.com/content/9/11/e031431.abstract N2 - Introduction The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.Methods and analysis This is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18–65 years) with obesity (body mass index 32–43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups 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 change in body weight from randomisation to end-of-treatment.Ethics and dissemination The trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.Trial registration number 2015-005585-32 ER -