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JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity

Study acronym: JOULE-MARS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2025 to Jun 18, 2025 · Secondary endpoints: 12 to 10 · Study description shortened, about 10 words · 2 morev3 Show 5 more changesShow less
    • Start date changed from estimate of Mar 2025 to Jun 18, 2025
    • Secondary endpoints: 12 to 10
    • Study description shortened, about 10 words
    • Site details revised
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Feb 2025 to Mar 2025 Secondary endpoints: details revised at 11 of 12 entries · Site contact updated · Study title shortened, about 5 wordsv2 Show 3 more changesShow less
    • Secondary endpoints: details revised at 11 of 12 entries
    • Site contact updated
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
McMaster University
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Obesity
3,560 trials monitored
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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 Details
NCT Number NCT06852391
Lead Sponsor McMaster University
Collaborators: Canadian Institutes of Health Research (CIHR), Diabetes Canada
Conditions Obesity (Disorder)
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov