Protocol for a randomised, double-blinded, controlled trial of youth with childhood-onset obesity treated with semaglutide [amount hidden]: the RESETTLE trial

What Was Tested

The paper reports a study of Semaglutide, published as a clinical study.

Therefore, this study investigates the effect of the glucagon-like peptide-1 receptor agonist, semaglutide, as an add-on to hospital-based obesity care in youth who still have obesity following hospital-based obesity care as children.

The trial has been approved by the Danish Medicines Agency and the Ethical Committee of the Capital Region of Denmark (H-20039422).

Who Took Part

According to the abstract, 270 adults were involved.

The age groups tagged for this paper are teenagers, young adults and adults, both men and women.

The researchers will enrol expectedly 180-270 young adults aged 18-28 years based on their previous response to a paediatric obesity management programme and their current body mass index (BMI).

The primary outcome is the change in BMI from randomisation to the end of treatment with semaglutide compared with placebo.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Some adults received a placebo instead of Semaglutide, giving a reference point.

This is an investigator-initiated, randomised, placebo-controlled, double-blind trial.

Secondary endpoints are changes in weight and body composition.

What Was Measured

The subject headings attached to it are Glucagon-Like Peptides, Pediatric Obesity, Body Mass Index, Randomized Controlled Trials as Topic, Weight Loss and Semaglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 270 adults.

The publication is from 2024 (BMJ open), a journal based in England.

More context: the Semaglutide compound page, all human trials.