Study design
weight loss
SECONDARY
This study is based on a randomized, double-blind (regarding liraglutide treatment), placebo-controlled trial (S-LiTE Randomized trial) conducted at Hvidovre Hospital and the University of Copenhagen, Denmark, from August 2016 to November 2019 (EudraCT number, 2015-005585-32; ClinicalTrials.gov number, NCT04122716) [Included participants were asked to complete a low-calorie diet for eight weeks before being randomized to either exercise, pharmacological treatment with liraglutide, the combination of exercise and liraglutide, or placebo for one year. All participants attended 12 individual consultations to support weight loss maintenance after randomization. These consultations included measurements of body weight and dietary support in compliance with the Danish Authorities’ dietary recommendations [The trial was approved by the Committee of Health Research Ethics and the Danish Medicines Agency and was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Participants provided written informed consent before inclusion. Investigators, assessors, and participants were blinded to study medication. Unblinding was done after the statistical analysis of the primary and secondary endpoints [