Metabolic response to a 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
This trial will test whether adding semaglutide to a behavioral weight-management program helps adolescents (12–17) with obesity avoid the usual drop in metabolism that follows weight loss.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06852391 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, open-label Phase 4 trial will enroll adolescents aged 12–17 with obesity who are already in affiliated pediatric weight-management clinics. Participants are randomized to either 6 months of a behavioral lifestyle program (BLP) alone followed by 6 months of BLP plus semaglutide, or to 6 months of BLP plus semaglutide from baseline. The primary outcome is change in resting energy expenditure and related measures of adaptive thermogenesis, with secondary outcomes including exercise work efficiency, brown adipose tissue activity, metabolic biomarkers, liver fat, and quality of life. Imaging and standardized metabolic testing will be performed at baseline and specified follow-up visits to compare the two approaches.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12–17 with obesity (BMI ≥2 standard deviations above the WHO median) who are enrolled in the Growing Health or Next Step pediatric weight-management clinics and have no contraindications to semaglutide or required imaging.
Not a fit: Patients with monogenic, syndromic, or hypothalamic causes of obesity, recent use of glucose-lowering or anti-obesity medications, certain medication contraindications, very high liver enzymes, or MRI/semaglutide contraindications may not benefit or be eligible.
Why it matters
Potential benefit: If successful, combining semaglutide with a behavioral program could reduce the metabolic slowdown after weight loss and improve weight and metabolic health in teens with obesity.
How similar studies have performed: Previous randomized trials have shown semaglutide produces substantial weight loss in adolescents, but its specific effects on adaptive thermogenesis when combined with behavioral programs are less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Hamilton, Ontario
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Katherine M Morrison, MD FRCPC — McMaster University
- Study coordinator: Athena Flores Miranda
- Email: joulemrs@mcmaster.ca
- Phone: 905-525-9140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.