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New treatment option for Obesity (Disorder)
Official title JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
ClinicalTrials.gov ID: NCT06852391
What this study is testing
What is Semaglutide Pen Injector?
Semaglutide Pen Injector is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity (disorder).
Also referred to as Wegovy®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- 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).
You likely can't join if
- Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight \>300lb. Ineligible for imaging visit...
- Use of atypical anti-psychotics.
- Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs...
- 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.
See the full eligibility 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).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.