Testing semaglutide with lifestyle changes in teens with obesity
Tests semaglutide plus lifestyle program versus lifestyle alone in teens with obesity.
Plain-language title generated from the registry record
Registry title: JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
Key facts
- Where
- Hamilton, CanadaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT06852391, who can take part
Where in Canada
- McMaster UniversityHamilton, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- McMaster University
- Trial code
- NCT06852391
- Record updated
- 14 January 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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).
Exclusion: Prior bariatric surgery or liver transplantation; Recent history of cigarette smoking (previous 3 months) - ineligible for imaging only; 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; 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.); Diagnosis of type 1 or 2 diabetes mellitus; 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; 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; 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; Known monogenic, syndromic or hypothalamic causes of obesity; Alcohol intake exceeding 3 drinks per week or reported cannabis use.