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

Sponsor
Hallym University
Study ID
NCT07621640
Status
Not Yet Recruiting

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Conditions

  • Brown Adipose Tissue
  • Metabolic Syndrome
  • Obesity

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 stimulation — PROCEDURE
    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
    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 Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Semaglutide + BAT Evaluation
    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.

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 ]

Central Contacts

  • Hun Jee Choe Hallym University Dongtan Sacred Heart Hospital, MD, PhD
    +82-31-8086-2869
    [email protected]
  • Hye Jeong Lee Hallym University Dongtan Sacred Heart Hospital, CRC
    +82-10-4694-3886
    [email protected]

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