Health TrialsbyHealthPanel

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

ConditionsObesityMetabolic SyndromeBrown Adipose Tissue
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorHallym University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-70 years at the time of enrollment

Initiating semaglutide (Wegovy) treatment for obesity (newly starting treatment)

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/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/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).

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Semaglutide + BAT EvaluationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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).

Time frame
Baseline to 24 weeks

Secondary outcomes

1

Change in waist circumference

Time frame
Baseline to 24 weeks
2

Change in body weight (kg)

Time frame
Baseline to 24 weeks
3

Change in Body Mass Index (BMI)

Time frame
Baseline to 24 weeks
4

Change in HbA1c (%)

Time frame
Baseline to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hallym University

Lead sponsor

Hallym University Dongtan Sacred Heart Hospital

Sponsor institution

Hallym University Dongtan Sacred Heart Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: