RecruitingPhase 4NCT06852391

JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity

JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity - a Randomized Controlled Trial

Sponsor

McMaster University

Enrollment

74 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity (Disorder)

Summary

The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Study participants will be randomized to one of two groups. Group A will follow a behavioral lifestyle program (BLP) alone for 6 months, followed by BLP and treatment with semaglutide for six months. Group B will be enrolled in BLP and semaglutide from baseline to 6 months. The primary research question will assess, in youth aged 12-17 years diagnosed with obesity and enrolled in a weight management program, if the implementation of a BLP together with semaglutide, compared to the implementation of BLP alone for 6 months leads to less adaptive thermogenesis.

Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

The Joule MARS study investigates how the body adapts its metabolism (particularly resting energy expenditure and exercise efficiency) when adolescents with obesity lose weight through a behavioral lifestyle program alone versus a behavioral program combined with the weight-loss medication semaglutide. Understanding these metabolic adaptations — sometimes called adaptive thermogenesis — matters because the body often fights back against weight loss by burning fewer calories. Eligible participants are youth aged 12–17 years diagnosed with obesity (BMI at least 2 standard deviations above the WHO median) who are already enrolled in a pediatric weight management clinic; those with type 1 or 2 diabetes, eating disorders, prior bariatric surgery, pregnancy, or certain medications are excluded. Participation involves being randomly assigned to one of two groups for 6 months, undergoing metabolic testing (including in a whole-room calorimeter), body composition scans, and MRI imaging, with semaglutide injections provided to one group. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Pen Injector

Semaglutide will be delivered by a subcutaneous injection using an injectable pen once weekly. Semaglutide is formulated with 5 approved doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg). Treatment will commence with the lowest dose and will be increased every 4 weeks to the maximum tolerable dose where they will remain for the remainder of the treatment. Participants who are taking the drug will have monthly visits to assess any adverse events, dose titration and drug adherence.

BEHAVIORALBehavioural Lifestyle Program (BLP)

The BLP will be delivered by the Growing Healthy Weight Management (GHWM) pediatric program at McMaster Children's Hospital. GHWM is a family-based program addressing health behaviours (nutritional pattern and eating behaviours, physical activity, sedentary time and sleep) and physical and mental health issues. In Year 1, the program typically includes 2 group sessions and monthly individualized sessions with the participant and their family. The interdisciplinary weight management team is comprised of a registered dietician, exercise physiologist, kinesiologist, social worker and/or psychologist, general pediatrician and pediatric endocrinologists.