Weight Management Program with Semaglutide for Obesity
JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
Recruiting
Phase 4Interventional Study
Obesity (Disorder)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
74 (estimated)
Sponsor
McMaster University · Other
Who this trial is looking for
This trial is looking for adolescents aged 12 to 17 who are dealing with obesity. Participants will either follow a behavioral lifestyle program alone or with a medication called semaglutide for six months.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetes
You may be able to join if
I am 12-17 years old
I have been diagnosed with obesity
I am enrolled in a pediatric weight management program
You may not be able to join if
I cannot have an MRI due to claustrophobia or metal implants
I have been taking atypical anti-psychotics
I have a history of pancreatitis
I have a known eating disorder
I am pregnant or breastfeeding
I have had recent cigarette smoking
I have a history of a cardiac condition that prevents exercise testing
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 behavio…
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.
Trial Locations
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Eligibility 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 contraindica…
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.
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