BAT-Sema

Not yet recruitingPhase NA

Brown Adipose Tissue as a Mechanistic Determinant of Semaglutide Treatment Response in Obesity (BAT-Sema Study)

Brown Adipose Tissue as a Mechanistic Determinant of GLP-1 Receptor Agonist Treatment Response in Adults With Obesity: A Multicenter Prospective Cohort Study Using ¹⁸FDG-PET/CT and Cold Stimulation Protocol

Lead sponsor

Hallym University

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥27•Established CVD

Primary endpoint

•Correlation between baseline BAT metabolic activity

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 IDNCT07621640

Org study ID2026-04-009

Secondary IDRS-2026-25483260National Research Foundation of Korea

Timeline

Milestones

Study first posted2026-06-02actual

Last update posted2026-06-02actual

Study start2026-06estimated (month precision)

Primary completion2028-02estimated (month precision)

Study completion2031-02estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age20 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Age 20-70 years at the time of enrollment

2. Initiating semaglutide (Wegovy) treatment for obesity (newly starting treatment)

3. BMI ≥ 27 kg/m² with at least one weight-related comorbidity:

–Hypertension (SBP ≥130 or DBP ≥80 mmHg, or on antihypertensive medication)

–Dyslipidemia (LDL-C ≥130, TG ≥150, or low HDL-C, or on lipid-lowering medication)

–Non-alcoholic fatty liver disease (NAFLD/MASLD, confirmed by imaging or ALT/AST ≥1.5× ULN)

–Obstructive sleep apnea (AHI ≥5/hr or clinically diagnosed)

–Established cardiovascular disease (CAD, stroke, PAD)

–Obesity-related osteoarthritis of knee or hip with functional impairment OR BMI ≥ 30 kg/m² (regardless of comorbidity)

4. Ability and willingness to provide written informed consent

Exclusion criteria

1. Diagnosis of type 1 or type 2 diabetes mellitus

2. History of neck surgery or radiation therapy to the neck

3. Use of anti-obesity medications within 1 month prior to enrollment, or current use of beta-adrenergic blocking agents

4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)

5. Active malignancy, severe renal disease (eGFR <30 mL/min/1.73m²), severe hepatic disease, or other severe endocrine disorders

6. Pregnancy or breastfeeding

7. Severe psychiatric illness or cognitive impairment precluding informed consent

8. Contraindication to MRI (pacemaker, cochlear implant, non-MRI-compatible implants)

9. Severe claustrophobia

Endpoints (18)

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

Weight & body composition

Other (unclassified)

Glycemic / diabetes

MASH / liver

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

6 endpoints

Primary/protocol endpoint

Correlation between baseline BAT metabolic activity (SUVmean and BAT volume on ¹⁸FDG-PET/CT) and percentage body weight loss at 24 weeks of semaglutide treatment

Time frame:Baseline to 24 weeks

descriptive

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (kg)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in body composition by BIA (fat mass, lean mass, skeletal muscle mass)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Quality of life using the Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) total score

Time frame:Baseline to 24 weeks

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in HbA1c (%)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting glucose (mg/dL)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-IR

Time frame:Baseline to 24 weeks

change from baseline, improvement

MASH / liver

2 endpoints

Secondary/protocol endpoint

Change in liver fat fraction (MRI-PDFF, %)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness by MRE (kPa)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in fasting lipids (LDL-C, HDL-C, TG, TC)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in hsCRP

Time frame:Baseline to 24 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in Quality of Life using the Short Form-36 Health Survey Version 2 (SF-36v2) domain scores

Time frame:Baseline to 24 weeks

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change in adipokines (adiponectin, leptin, NEFA)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

BAT-positive rate based on SUVmax at baseline

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Change in BAT activity (SUVmax, SUVmean, BAT volume, TMA) from baseline to 24 weeks

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

BAT-positive rate based on CT Hounsfield Units (HU) at baseline

Time frame: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.