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ObesityBAT-SemaNCT07621640

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

A study testing Semaglutide (Wegovy®), ¹⁸FDG-PET/CT with cold stimulation and Liver MRI (PDFF + MRE) in people with Obesity and Metabolic Syndrome, run by Hallym University at 2 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study investigates whether the activity of brown adipose tissue (BAT) - a special type of fat that burns energy as heat - can predict how well individuals with obesity respond to semaglutide (Wegovy), a once-weekly injectable weight loss medication. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Obesity, Metabolic Syndrome, Brown Adipose Tissue
What is being tested?
Semaglutide (Wegovy®), ¹⁸FDG-PET/CT with cold stimulation and Liver MRI (PDFF + MRE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesSouth Korea
Study dates
Jun 2026to Feb 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20-70 years at the time of enrollment
  • Initiating semaglutide (Wegovy) treatment for obesity (newly starting treatment)
  • 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)
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  • 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)
  • Ability and willingness to provide written informed consent

Who cannot join

  • Diagnosis of type 1 or type 2 diabetes mellitus
  • History of neck surgery or radiation therapy to the neck
  • Use of anti-obesity medications within 1 month prior to enrollment, or current use of beta-adrenergic blocking agents
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
  • Active malignancy, severe renal disease (eGFR <30 mL/min/1.73m²), severe hepatic disease, or other severe endocrine disorders
  • Pregnancy or breastfeeding
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  • Severe psychiatric illness or cognitive impairment precluding informed consent
  • Contraindication to MRI (pacemaker, cochlear implant, non-MRI-compatible implants)
  • Severe claustrophobia

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD contact

+82-31-8086-2869

hunjeechoe@gmail.com

Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC contact

+82-10-4694-3886

geumzzogi@naver.com

South Korea2 sites
  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, Gyeonggi-do, 18450

    Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD, +82-10-9493-5703, hunjeechoe@gmail.com

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Soo Lim Seoul National University Bundang Hospital, MD, PhD, +82-10-9766-2706, limsoo@snu.ac.kr

    Soo Lim Seoul National University Bundang Hospital, MD, PhD, +82-010-9766-2706, limsoo@snu.ac.kr

Other trials in South Korea

About this study

Official title: 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

This study investigates whether the activity of brown adipose tissue (BAT) - a special type of fat that burns energy as heat - can predict how well individuals with obesity respond to semaglutide (Wegovy), a once-weekly injectable weight loss medication. Participants who are starting semaglutide treatment will undergo ¹⁸FDG-PET/CT imaging before and after 24 weeks of treatment. Prior to each PET/CT scan, participants will wear a water-circulating cooling vest to activate BAT. By measuring BAT activity at baseline and comparing it with the degree of weight loss and metabolic improvement at 24 weeks, the investigators aim to identify BAT as a predictive biomarker for personalized obesity treatment.

Read the detailed description

Despite the remarkable efficacy of semaglutide (GLP-1 receptor agonist) in treating obesity, considerable individual variation in treatment response remains unexplained. Brown adipose tissue (BAT) is a metabolically active thermogenic organ that has been implicated in energy expenditure, insulin sensitivity, and cardiometabolic health. We hypothesize that baseline BAT activity, as measured by ¹⁸FDG-PET/CT following individualized cold stimulation, is a mechanistic determinant of semaglutide treatment response in adults with obesity without diabetes.

This multicenter prospective cohort study will enroll 80 adults (40 per site: Hallym University Dongtan Sacred Heart Hospital and Seoul National University Bundang Hospital) with BMI ≥27 kg/m² plus obesity-related comorbidity, or BMI ≥30 kg/m², who are initiating semaglutide therapy. ¹⁸FDG-PET/CT with standardized cold stimulation (water-circulating cooling vest, starting at 16°C, individualized to prevent shivering) will be performed at baseline (V1) and 24 weeks (V7). BAT activity (SUVmax, SUVmean, BAT volume, total metabolic activity) will be quantified per BARCIST 1.0 criteria. Liver fat fraction (MRI-PDFF) and liver stiffness (MR elastography) will be assessed as secondary endpoints. Correlations between baseline BAT parameters and treatment outcomes (% body weight loss, metabolic biomarker changes) will be analyzed.

Being tested
Semaglutide (Wegovy®), ¹⁸FDG-PET/CT with cold stimulation, Liver MRI (PDFF + MRE)
Keywords
Brown adipose tissue, Semaglutide, GLP-1 receptor agonist, Obesity, FDG-PET/CT, BAT, Biomarker, Weight loss, PDFF
Medical subject headings
Obesity, Metabolic Syndrome, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide (Wegovy®)Drug

    Once-weekly subcutaneous injection, titrated from 0.25 mg to 2.4 mg over 20 weeks per standard protocol. Standard of care treatment for obesity.

  • ¹⁸FDG-PET/CT with cold stimulationProcedure or surgery

    Whole-body ¹⁸FDG-PET/CT (5.18 MBq/kg, max 370 MBq) after 60-minute individualized cold stimulation using a water-circulating cooling vest (Polar Products Arctic Chiller, starting 16°C). Performed at baseline (V1) and 24 weeks (V7). BAT activity quantified per BARCIST 1.0.

  • Liver MRI (PDFF + MRE)Procedure or surgery

    Hepatic proton density fat fraction (MRI-PDFF) and liver stiffness by MR elastography (MRE) using Siemens MAGNETOM Vida 3T. Performed at baseline (V1) and 24 weeks (V7).

Study groups in NCT07621640
Study groupRoleWhat they receive
Semaglutide + BAT EvaluationExperimentalAdults with obesity initiating semaglutide (0.25 mg → 2.4 mg over 20 weeks, maintained for 4 weeks; total 24 weeks). At baseline and 24 weeks, ¹⁸FDG-PET/CT with individualized cold stimulation (water-circulating cooling vest at 16°C, 60 minutes) and liver MRI (PDFF + MRE) are performed.
Receives: Drug: Semaglutide (Wegovy®); Procedure: ¹⁸FDG-PET/CT with cold stimulation; Procedure: Liver MRI (PDFF + MRE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    : Pearson (or Spearman) correlation coefficient between baseline BAT parameters (SUVmean, BAT volume, total metabolic activity per BARCIST 1.0) and % body weight loss after 24 weeks of semaglutide therapy (0.25 mg escalated to 2.4 mg).

    Measured: Baseline to 24 weeks

Secondary outcomes (17)
  1. Change in waist circumference

    Measured: Baseline to 24 weeks

  2. Change in body weight (kg)

    Measured: Baseline to 24 weeks

  3. Change in Body Mass Index (BMI)

    Measured: Baseline to 24 weeks

  4. Change in HbA1c (%)

    Measured: Baseline to 24 weeks

  5. Change in fasting glucose (mg/dL)

    Measured: Baseline to 24 weeks

  6. Change in HOMA-IR

    Measured: Baseline to 24 weeks

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

    Measured: Baseline to 24 weeks

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

    Measured: Baseline to 24 weeks

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

    Measured: Baseline to 24 weeks

  10. Change in liver stiffness by MRE (kPa)

    Measured: Baseline to 24 weeks

  11. Change in adipokines (adiponectin, leptin, NEFA)

    Measured: Baseline to 24 weeks

  12. Change in hsCRP

    Measured: Baseline to 24 weeks

  13. BAT-positive rate based on SUVmax at baseline

    The percentage of participants determined as brown adipose tissue (BAT)-positive, defined by a maximum standardized uptake value (SUVmax) of 1.5 or higher ($\ge 1.5$) at baseline.

    Measured: Baseline

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

    The Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) is a self-report questionnaire used to assess the quality of life in individuals with obesity. The total score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better outcome (better quality of life).

    Measured: Baseline to 24 weeks

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

    The Short Form-36 Health Survey Version 2 (SF-36v2) is a 36-item questionnaire measuring health-related quality of life across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better outcome (better health status or higher quality of life).

    Measured: Baseline to 24 weeks

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

    Measured: Baseline to 24 weeks

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

    The percentage of participants determined as brown adipose tissue (BAT)-positive, defined by Computed Tomography Hounsfield Units (CT HU) within the range of $-250$ to $-50$ at baseline.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm prospective mechanistic cohort study evaluating the association between baseline brown adipose tissue activity and semaglutide treatment response in adults with obesity using individualized cold-stimulated ¹⁸FDG-PET/CT.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621640
Sponsor's protocol ID
2026-04-009
Other IDs
RS-2026-25483260
Acronym
BAT-Sema
Status last verified
Jul 2026
First submitted
20 May 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly. De-identified aggregate results will be published in peer-reviewed journals

Questions about this trial

What is this clinical trial studying?

A study testing Semaglutide (Wegovy®), ¹⁸FDG-PET/CT with cold stimulation and Liver MRI (PDFF + MRE) in people with Obesity and Metabolic Syndrome, run by Hallym University at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD (+82-31-8086-2869, hunjeechoe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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