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

NCT07621640 · Not yet recruiting

Last updated 2026-07-13

This clinical trial is studying whether the amount and activity of brown fat in adults with obesity can help predict how well they will respond to the weight-loss medication semaglutide over a 24-week period.

Status Not yet recruiting Approved but enrollment has not started.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design open-label (no blinding) basic-science study

Participants 80 people Planned (estimated).

Who can join Ages 20–70 · all sexes

Timeline Started 2026-06 · est. completion 2031-02

Where 2 sites · South Korea

What this study is testing ClinicalTrials.gov NCT07621640 ↗

Description as written by the study sponsor.

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.

Treatments tested

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).

Main thing measured	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
Sponsor	Hallym University
Conditions studied	Obesity, Metabolic Syndrome, Brown Adipose Tissue
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07621640 ↗