NCT06852391RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 18 Jun 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- McMaster University
- Diseases
- Obesity
- NCT number
- NCT06852391
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 74
- From 18 Jun 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.