Recruiting

BLP with Semaglutide

Sponsor:

McMaster University

Code:

NCT06852391

Conditions

Obesity (Disorder)

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Semaglutide Pen Injector

Behavioural Lifestyle Program (BLP)

Study Details

Brief summary:

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

Obesity (Disorder)

Study ID

NCT06852391

Start date

Jun 18, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BLP, then BLP+semaglutide

Group A will engage in a BLP alone for the first six months of the study, then receive BLP and semaglutide (Wegovy®) for the last six months of the study, beginning with 0.25 mg subcutaneously weekly and being titrated every four weeks up to a maximum of 2.4 mg in approved doses 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg.

experimental: BLP and semaglutide

In addition to BLP, Group B will receive semaglutide (Wegovy®) titrated to maximal dose tolerated, in approved doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg subcutaneously weekly for 6 months .

Interventions

Semaglutide Pen Injector

Semaglutide will be delivered by a subcutaneous injection using an injectable pen once weekly. Semaglutide is formulated with 5 approved doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg). Treatment will commence with the lowest dose and will be increased every 4 weeks to the maximum tolerable dose where they will remain for the remainder of the treatment. Participants who are taking the drug will have monthly visits to assess any adverse events, dose titration and drug adherence.

Behavioural Lifestyle Program (BLP)

The BLP will be delivered by the Growing Healthy Weight Management (GHWM) pediatric program at McMaster Children's Hospital. GHWM is a family-based program addressing health behaviours (nutritional pattern and eating behaviours, physical activity, sedentary time and sleep) and physical and mental health issues. In Year 1, the program typically includes 2 group sessions and monthly individualized sessions with the participant and their family. The interdisciplinary weight management team is comprised of a registered dietician, exercise physiologist, kinesiologist, social worker and/or psychologist, general pediatrician and pediatric endocrinologists.

Primary outcome measure

  • Measurement of Adaptive thermogenesis [ Time Frame: 6, 12 months ]

Central Contacts and Locations

Central contacts

Athena Flores Miranda

905-525-9140joulemrs@mcmaster.ca

Aaron Thomas, PhD

905-525-9140joulemrs@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Athena Flores Miranda

905-525-9140joulemrs@mcmaster.ca

Aaron Thomas

905-525-9140joulemrs@mcmaster.ca

Principal Investigator:

Katherine M Morrison, MD FRCPC

More Information

Sponsor

McMaster University

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Adaptive Thermogenesis
  • obesity
  • semaglutide
  • GLP-1 agonist
  • weight loss
  • Energy expenditure
  • Whole room calorimetry
  • MRI
  • MR elastography
  • Cold exposure
  • Liver stiffness
  • Brown adipose tissue
  • Pediatric
  • Quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-01-14.