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Clinical Trials in South Korea / NCT07621640
Starting soon Not applicable

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

NCT07621640 · tracked via the Priya Life Science South Korea tracker
Sponsor
Hallym University
Phase
Not applicable
Started
2026-06
Last updated
2026-07-22

Condition(s) studied

ObesityMetabolic SyndromeBrown Adipose Tissue

Investigational drug(s) / intervention(s)

Semaglutide (Wegovy®) →¹⁸FDG-PET/CT with cold stimulationLiver MRI (PDFF + MRE)

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.

¹⁸FDG-PET/CT with cold stimulation: 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): 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 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. 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — 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).

Trial sites (2)

FacilityCityRegionStatus
Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Gyeonggi-do
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07621640 on ClinicalTrials.gov ↗ ← All trials in South Korea