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WAIT

Not yet recruitingPhase 4

Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study

Lead sponsor

Emma Svennberg

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

200

estimated

Study population

Atrial fibrillation, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Atrial-fibrillation composite (Atrial-fibrillation composite)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07275697

Org study IDWAIT

Secondary ID2025-524182-25-00

Timeline

Milestones

Study first posted2025-12-10actual

Last update posted2025-12-10actual

Study start2025-12-15estimated

Primary completion2028-12-30estimated

Study completion2028-12-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Atrial fibrillationObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

To be included in the trial, subjects must meet all of the following criteria:

1. Provision of written informed consent prior to participation.

2. Age ≥18 years.

3. Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.

4. Body Mass Index (BMI) ≥30 kg/m² (obesity) OR

BMI ≥27 kg/m² (overweight) with one or more of the following comorbidities:

–prediabetes (defined as HbA1c 39-47 mmol/mol or fasting glucose 5,6-6,9 mmol/L),

–known diabetes type 2

–known hypertension (prior diagnosis and/or treatment with antihypertensive medication)

–new diagnosis of hypertension (according to ESC GL for hypertension: Systolic BP ≥140 mmHg and/or diastolic BP ≥ 90 mmHg based on two readings on two separate visits, OR Ambulatory BP monitoring (24h average) ≥ 130/80 mmHg)

–dyslipidemia defined as either one of the following

–Known diagnosis of hyperlipidemia or

–Treatment with lipid lowering medication

OR either of the following:

–LDL > 3.0 mmol/l

–Total cholesterol > 5 mmol/l

–Triglycerides > 1.7 mmol/l

–HDL (< 1 mmol/l if male, < 1.2 mmol/l if female) AND/OR

–atherosclerotic cardiovascular disease (prior myocardial infarction (MI), stroke, or peripheral arterial disease with claudication and ankle-brachial index <0.85, prior revascularization, or amputation)

–obstructive sleep apnea.

5. For women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide).

Exclusion criteria

•Morbid obesity (BMI >40 kg/m²).

•Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.

•Current use of DPP-IV inhibitors.

•Diabetes type 1

•Known intolerance or contraindication to semaglutide.

•History of pancreatitis or recurrent hypoglycemia.

•Uncontrolled diabetic retinopathy

•Severe renal failure (estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m² or in dialysis)

•Severe hepatic failure (decompensated liver disease Child-Pugh class C)

•Severe cardiac failure (NYHA class IV)

•Life expectancy <12 months.

•Inability to self-administer the investigational medicinal product.

•Prior catheter ablation procedure for atrial fibrillation.

•Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.

•Participation in another interventional clinical trial within the past 30 days.

Endpoints (21)

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.

Coverage by outcome category

Cardiovascular outcomes

Other (unclassified)

Other clinical outcomes

Patient-reported / QoL

Weight & body composition

Heart failure

Cardiometabolic biomarkers

Safety / tolerability / PK

Cardiovascular outcomes

7 endpoints

Primary/protocol endpoint

Arrhythmia-free survival at 12 months after catheter ablation, excluding the 3-month blanking period, with recurrence defined as any ILR-detected AF, atrial flutter, or atrial tachycardia ≥30 seconds.

Time frame:12 months post-ablation

Atrial-fibrillation composite

time to event, event

componentsAtrial-fibrillation composite

Secondary/protocol endpoint

Per protocol analysis of the primary outcome

Time frame:12 months post-ablation

Atrial-fibrillation composite

time to event, event

componentsAtrial-fibrillation composite

Secondary/protocol endpoint

Time to first arrhythmia recurrence after the blanking period

Time frame:From month 3 to month 12 post-ablation.

Atrial-fibrillation composite

time to event, event

componentsAtrial-fibrillation composite

Secondary/protocol endpoint/low confidence

Freedom from symptomatic AF without redo ablation

Time frame:From index ablation to 12 months post-ablation.

Atrial-fibrillation composite

threshold achievement, improvement

componentsAtrial-fibrillation composite, Cerebrovascular revascularization

Secondary/protocol endpoint

Cardiovascular hospitalization

Time frame:From index ablation to 12 months post-ablation.

time to event, event

Secondary/protocol endpoint

All-cause hospitalization

Time frame:From index ablation to 12 months post-ablation.

All-cause hospitalization

time to event, event

Secondary/protocol endpoint/low confidence

Healthcare utilization

Time frame:From randomization to 12 months post-ablation.

event count, descriptive

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Weight loss ≥10% or BMI <27 kg/m² at time of ablation and at 12 months post ablation

Time frame:At the time of ablation and at 12 months post-ablation.

≥10% weight-loss responders

threshold achievement, improvement

components≥10% weight-loss responders, BMI, change

Heart failure

1 endpoint

Secondary/protocol endpoint

Left ventricular ejection fraction (LV-EF) pre- and post-ablation

Time frame:At routine clinical echocardiography closest to baseline and the post-ablation assessment (up to 12 months).

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Blood pressure reduction

Time frame:At baseline, at the time of ablation, and at 12 months post-ablation.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Symptom burden using questionnaires at baseline, ablation, 12 months

Time frame:At baseline, at the time of ablation, and at 12 months post-ablation

change from baseline, improvement

Secondary/protocol endpoint

Quality of life changes using RAND-36

Time frame:At baseline, at the time of ablation, and at 12 months post-ablation.

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Complications during and after the ablation procedure

Time frame:During the ablation procedure and through 12 months post ablation.

event count, event

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint

Number of repeat ablations required to achieve sinus rhythm

Time frame:From index ablation to 12 months post-ablation.

event count, event

Secondary/protocol endpoint

Change in antiarrhythmic drug use

Time frame:From baseline to 12 months post-ablation.

descriptive

Secondary/protocol endpoint

Ablation procedure duration

Time frame:During the index ablation procedure.

descriptive

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

AF burden

Time frame:At ablation and at 12 months post-ablation.

descriptive

Secondary/protocol endpoint/low confidence

Changes in blood biomarkers including glucose levels, HbA1c, creatinine and NT-proBNP

Time frame:At routine clinical assessments nearest to baseline, ablation, and 12 months post-ablation.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Prevalence of diabetes, renal failure, and heart failure

Time frame:At baseline and at 12 months post-ablation (via clinical records and registry data).

descriptive

componentsTime to T2DM onset, Custom renal composite, Heart-failure composite

Secondary/protocol endpoint/low confidence

Fluoroscopy time and radiation dose

Time frame:During the index ablation procedure.

descriptive

Other/protocol endpoint/low confidence

Artificial-intelligence based prediction of arrhythmia recurrence from 12-lead ECG

Time frame:ECGs recorded as part of routine care at baseline, at ablation, and during follow-up up to 12 months post-ablation

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.