Actively Recruiting
JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
Led by McMaster University · Updated on 2026-01-14
74
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth aged 12-17 years
- Diagnosed with obesity (BMI 2 standard deviations above WHO Reference median)
- Enrolled in Growing Healthy Weight Management or Next Step pediatric clinics with at least one year remaining in the program
You will not qualify if you...
- Contraindications for MRI such as claustrophobia, implanted metal, recent tattoo, or weight over 300 lb (only ineligible for imaging)
- Use of atypical anti-psychotics
- Use of beta-blockers, steatogenic medications, anti-hyperglycemics, HIV drugs, antidepressants, anxiolytics, anti-psychotics, thyroid drugs, antiemetics, amphetamines, dextromethorphan, or metoclopramide
- Elevated alanine aminotransferase (ALT) greater than 5 times the upper normal limit
- 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 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 eating disorder or suicidal ideation
- History of cardiac condition precluding exercise testing or inability to use a cycle ergometer
- No peak power value obtained in the pediatric clinic
- Female who is pregnant, breast-feeding, intends to become pregnant, or refuses contraception if sexually active
- Participation in any interventional clinical study within 90 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McMaster University
Hamilton, Ontario, Canada, L8S 4L8
Actively Recruiting
Research Team
A
Athena Flores Miranda
CONTACT
A
Aaron Thomas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here