SPICE-AF

Not yet recruitingPhase 4

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation (SPICE-AF)

Lead sponsor

University of Luebeck

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

240

Study population

Atrial fibrillation, Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Freedom from atrial arrhythmia (Atrial-fibrillation composite)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07389941

Org study IDSPICE_AF

Timeline

Milestones

Study first posted2026-02-05actual

Last update posted2026-02-11actual

Study start2026-10estimated (month precision)

Primary completion2029-04estimated (month precision)

Study completion2029-04estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Atrial fibrillationObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 18-80 years

•Symptomatic paroxysmal or persistent AF eligible for first-time catheter ablation

•Body mass index ≥30 kg/m or body mass index ≥28 kg/m plus ≥1 weight-related comorbidity

•No prior treatment with glucacon-like peptide-1 receptor agonists

Exclusion criteria

•Current use of glucacon-like peptide-1 receptor agonists or 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 within 30 days before screening

•History of bariatric surgery

•History of diabetes mellitus

•Hospitalization for unstable angina, or transient ischemic attack <30 days prior to screening

•Pulmonary embolism <90 days before screening

•Myocardial infarction, or stroke <90 days prior to screening

•Uncontrolled thyroid disease: thyroid-stimulating hormone >10.0 mIU/L or <0.4 mIU/L at screening

•Active malignancy

•Acute pancreatitis <180 days before screening

•History or presence of chronic pancreatitis

•Chronic kidney disease with creatinine clearance <30 mL/min

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

•Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids

•Pregnancy, breast-feeding or planning pregnancy

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Cardiovascular outcomes

1 endpoint

Primary/protocol endpoint/low confidence

Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)

Time frame:12 months

categorical status, improvement

componentsAtrial-fibrillation composite

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.