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.
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)
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC contact
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
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.
- Conditions
- Obesity, Metabolic Syndrome, Brown Adipose Tissue
- 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 group | Role | What they receive |
|---|---|---|
| Semaglutide + BAT Evaluation | Experimental | Adults 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.
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)
Change in waist circumference
Measured: Baseline to 24 weeks
Change in body weight (kg)
Measured: Baseline to 24 weeks
Change in Body Mass Index (BMI)
Measured: Baseline to 24 weeks
Change in HbA1c (%)
Measured: Baseline to 24 weeks
Change in fasting glucose (mg/dL)
Measured: Baseline to 24 weeks
Change in HOMA-IR
Measured: Baseline to 24 weeks
Change in fasting lipids (LDL-C, HDL-C, TG, TC)
Measured: Baseline to 24 weeks
Change in body composition by BIA (fat mass, lean mass, skeletal muscle mass)
Measured: Baseline to 24 weeks
Change in liver fat fraction (MRI-PDFF, %)
Measured: Baseline to 24 weeks
Change in liver stiffness by MRE (kPa)
Measured: Baseline to 24 weeks
Change in adipokines (adiponectin, leptin, NEFA)
Measured: Baseline to 24 weeks
Change in hsCRP
Measured: Baseline to 24 weeks
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
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
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
Change in BAT activity (SUVmax, SUVmean, BAT volume, TMA) from baseline to 24 weeks
Measured: Baseline to 24 weeks
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.
- First posted2 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hallym University
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Dongtan Sacred Heart Hospital
- Responsible party
- Principal investigator, Hun Jee Choe, Hallym University Dongtan Sacred Heart Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07621640
- Acronym / sponsor ID
- BAT-Sema / 2026-04-009
- Conditions
- Obesity, Metabolic Syndrome, Brown Adipose Tissue
- Keywords
- Brown adipose tissue, Semaglutide, GLP-1 receptor agonist, Obesity, FDG-PET/CT, BAT, Biomarker, Weight loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hallym UniversityUniversity, hospital or other
- Collaborators
- Hallym University Dongtan Sacred Heart Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide + BAT Evaluation | Experimental | Drug: Semaglutide (Wegovy®), Procedure: ¹⁸FDG-PET/CT with cold stimulation, Procedure: Liver MRI (PDFF + MRE)Adults 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Ability and willingness to provide written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Wegovy®)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. | Drug | Semaglutide + BAT Evaluation |
| ¹⁸FDG-PET/CT with cold stimulationWhole-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. | Procedure or surgery | Semaglutide + BAT Evaluation |
| Liver MRI (PDFF + MRE)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). | Procedure or surgery | Semaglutide + BAT Evaluation |
Primary outcome
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
: 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).
17 secondary outcomes
Change in waist circumference
Time frame: Baseline to 24 weeks
Change in body weight (kg)
Time frame: Baseline to 24 weeks
Change in Body Mass Index (BMI)
Time frame: Baseline to 24 weeks
Change in HbA1c (%)
Time frame: Baseline to 24 weeks
Change in fasting glucose (mg/dL)
Time frame: Baseline to 24 weeks
Change in HOMA-IR
Time frame: Baseline to 24 weeks
Change in fasting lipids (LDL-C, HDL-C, TG, TC)
Time frame: Baseline to 24 weeks
Change in body composition by BIA (fat mass, lean mass, skeletal muscle mass)
Time frame: Baseline to 24 weeks
Change in liver fat fraction (MRI-PDFF, %)
Time frame: Baseline to 24 weeks
Change in liver stiffness by MRE (kPa)
Time frame: Baseline to 24 weeks
Change in adipokines (adiponectin, leptin, NEFA)
Time frame: Baseline to 24 weeks
Change in hsCRP
Time frame: Baseline to 24 weeks
BAT-positive rate based on SUVmax at baseline
Time frame: Baseline
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 in Quality of Life using the Short Form-36 Health Survey Version 2 (SF-36v2) domain scores
Time frame: Baseline to 24 weeks
Change in BAT activity (SUVmax, SUVmean, BAT volume, TMA) from baseline to 24 weeks
Time frame: Baseline to 24 weeks
BAT-positive rate based on CT Hounsfield Units (HU) at baseline
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified aggregate results will be published in peer-reviewed journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD contact
Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC contact
2 sites in 1 country: see every site and its status.
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.