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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Youth aged 12-17 years
• Diagnosed with obesity (BMI ≥2 standard deviations above WHO Reference median)
• Enrolled in Growing Health Weight Management or Next Step pediatric clinics (ie. have at least one year of the program remaining).

🚫 You may not be able to join if…

• Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight >300lb. Ineligible for imaging visit only.
• Use of atypical anti-psychotics.
• Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs, Antidepressants, anxiolytic drugs, anti-psychotic drugs, Thyroid drugs, Antiemetic or amphetamine, dextromethorphan and metoclopramide.)
• Elevated alanine aminotransferase (ALT) > 5 x upper range of normal at screening.
• Use of glucose lowering or any anti-obesity medication in the previous 3 months.
• Known monogenic, syndromic or hypothalamic causes of obesity.
• Diagnosis of type 1 or 2 diabetes mellitus.
• Prior bariatric surgery or liver transplantation.
• Alcohol intake exceeding 3 drinks per week or reported cannabis use.
• Recent history of cigarette smoking (previous 3 months) - ineligible for imaging only.
• History or family history of multiple endocrine neoplasia 2 or medullary thyroid cancer.
• History of pancreatitis.
• Presence of untreated endocrine disorder.
• History of an eating disorder and / or history of suicidal ideation
• History of a cardiac condition that precludes exercise testing or unable to have exercise testing done in the GHWM pediatric clinic, inability to use a cycle ergometer. Participant who does not have a peak power value obtained in the GHWM pediatric clinic Female who is pregnant, breast-feeding or intends to become pregnant. Female who refuses to use a means of contraception if sexually active. Participation in any interventional clinical study within 90 days before screening.

Where this trial is running

• McMaster University, Hamilton, Ontario, Canada

Who to contact

Athena Flores Miranda · 905-525-9140 · joulemrs@mcmaster.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06852391.