DelfaGLP-1 Atlas

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JOULE-MARS

RecruitingPhase 4

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

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

74

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥2•Age 12-17

Primary endpoint

•Measurement of Adaptive thermogenesis

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06852391
Org study ID18026

Timeline

Milestones

Study first posted2025-02-28actual
Study start2025-06-18actual
Last update posted2026-01-14actual
Primary completion2027-12-31estimated
Study completion2027-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersNot 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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
3
Weight & body composition
2
Glycemic / diabetes
2
Other (unclassified)
2
Cardiometabolic biomarkers
1
Patient-reported / QoL
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Brown Adipose Tissue (BAT) activity

Time frame:From enrollment to 6 months and to 12 months

percent change from baseline, improvement

Secondary/protocol endpoint

Total body mass, fat mass and lean mass

Time frame:Baseline, 6, 12 months

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Fasting insulin

Time frame:Baseline, 6, 12 months

change from baseline, improvement

Secondary/protocol endpoint

Hemoglobin A1C

Time frame:Baseline, 6 and 12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

3 endpoints
Secondary/protocol endpoint

Hepatic fat content

Time frame:Baseline, 6, 12 months

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Hepatic stiffness

Time frame:Baseline, 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Alanine aminotransferase

Time frame:Baseline, 3, 6, 9 and 12 months

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Fasting lipid profile

Time frame:Baseline, 6, 12 months

descriptive

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Health-related quality of life (HRQoL)

Time frame:Baseline to 6 months and to 12 months

IWQOL-Lite total

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Measurement of Adaptive thermogenesis

Time frame:6, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in energy work efficiency from baseline during standardized exercise

Time frame:Baseline, 6, 12 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.