Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Chicago
About this trial
The goal of the study is to learn how a weight loss medication called semaglutide, which is used to treat obesity, in addition to standard AF treatment might affect AF, atrial fibrillation severity, and whether it changes the risk of atrial fibrillation recurring after standard AF treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years
BMI greater than or equal to 30 kg/m2
Paroxysmal AF or persistent AF, in whom catheter ablation (CA) for AF is expected within 1 year (A group) or in whom catheter ablation is NOT expected within 1 year (M group)
Ability to provide informed consent before any trial-related activities.
Disqualifiers
Current use of GLP-1 RA (glucagon-like peptide receptor agonists) or DPP4 (Dipeptidyl peptidase-4)-inhibitors or use within the last 90 days prior to screening
Current antiobesity medication use or use within the last 90 days prior to screening
A self-reported change in body weight of > 5 kg (11 lb.) within 30 days before screening
History of bariatric surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide
Drug3ml pen-injector containing semaglutide 3.0mg/ml solution for subcutaneous use.
Placebo
Drug3ml pen-injector containing placebo solution for subcutaneous use.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: SemaglutideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to first AF event detected by routine outpatient monitoring
Defined by length of time detected by routine outpatient monitoring (Holter, mobile telemetry, or implantable loop recorder).
Time frame
Baseline to Week 682
Change from baseline in AF burden detected by routine outpatient monitoring.
Defined as the percentage of time spent in atrial fibrillation as detected by routine outpatient monitoring (Holter, mobile telemetry, or implantable loop recorder).
Time frame
Baseline to Week 68Secondary outcomes
1
Weight loss
Change in Weight (kilograms) measured.
Time frame
Baseline to Week 682
Change in waist circumference
Change waist circumference (cm) measured.
Time frame
Baseline to Week 683
Change in epicardial and/or pericardial adipose tissue volume
Decrease measured by Cardiovascular magnetic resonance
Time frame
Baseline to Week 684
Change in left and right ventricular size (mass)
Change in left and right ventricular size derived from time volume curves, and left and right atrial volumes (mL) measured by cardiovascular magnetic resonance
Time frame
Baseline to Week 68Sponsors and contacts
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Source ClinicalTrials.gov