DANWRAP

Not yet recruitingPhase NA

Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression

The Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression

Lead sponsor

Axel Brandes

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

480

Study population

Atrial fibrillation, Obesity / overweight

Eligibility highlights

•BMI ≥27

Primary endpoint

•Hierarchical composite outcome capturing AF progression and AF burden

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 IDNCT07816744

Org study IDS-20260028

Timeline

Milestones

Study first posted2026-09-14actual

Study start2026-10-01estimated

Last update posted2026-10-05actual

Primary completion2030-04estimated (month precision)

Study completion2030-09estimated (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

•Symptomatic paroxysmal* or persistent** AF

•Sinus rhythm at inclusion (Visit 1)

•BMI ≥27 kg/m2

•Age>18 years

•At least one 12-lead ECG or other single- or multiple-lead ECG device (e.g. Holter monitor-ing or ECG-providing wearables) documented episode during 6 months prior to inclusion

* Paroxysmal AF in this trial is defined as at least 2 episodes, either self-terminating or cardioverted within 7 days, during 6 months prior to in-clusion

**Persistent AF in this study is defined as the following:

•Duration of an AF episode >7 days and < 6 months

•Total documented AF history < 5 years

Exclusion criteria

•Atrial flutter as the primary arrhythmia. (Patients with previous or isolated episodes of atrial flutter may be included, provided that AF is the dominant arrhythmia and the primary target of clinical management)

•Implanted electronic device (pacemaker/ICD/ICM)

•Type 1 diabetes or Type 2 diabetes on insulin treatment

•Severe heart failure (LVEF <40%)

•Inability to sign informed consent

•Severe kidney disease (eGFR<30)

•History of catheter ablation for AF

•Scheduled to receive catheter ablation for AF during the study period (next 1 year)

•Incretin-based therapy (GLP-1 receptor agonists or DPP-IV inhibitors) within 30 days prior to randomization (visit 1)

•Scheduled for bariatric surgery during the study period

•Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis

•Chronic or previous acute pancreatitis

•Current participation in any other clinical intervention trial that may result in changes to med-ical management during the study period

•Women of childbearing potential who are not on an acceptable form of contraception

•Pregnant or breastfeeding women

•Personal or family history of medullary thyroid carcinoma (MTC)

•History of MEN2 (Multiple Endocrine Neoplasia type 2)

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.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Hierarchical composite outcome capturing AF progression and AF burden, inte-grating clinical events assessed by blinded adjudication and objective measures of AF burden, assessed by 14-day continuous ECG monitoring

Time frame:From 4 months to 12 months after enrollment

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.