Metabolic response to a lifestyle program with or without semaglutide in adolescents with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.