Skip to main content
Delfa

← All trials/NCT05209165

SuspendedPhase 4

Semaglutide to Reduce Atrial Fibrillation Burden

Semaglutide as Treatment of Overweight and Obese Individuals to Reduce Atrial Fibrillation Burden

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

132

Study population

Atrial fibrillation, Obesity / overweight

Eligibility highlights

BMI ≥27

Primary endpoint

Atrial fibrillation 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 IDNCT05209165
Org study IDSFVAEP1

Timeline

Milestones

Study first posted2022-01-26actual
Last update posted2022-10-27actual
Study start2023-05estimated (month precision)
Primary completion2027-05estimated (month precision)
Study completion2028-05estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Atrial fibrillationObesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Patients ≥ 18 years old with a BMI ≥ 27 kg/m2 who have paroxysmal AF with a ≥ 10% burden on ambulatory monitoring or a previous electrical cardioversion or early persistent AF (≥ 7 days, < 3 months) who are willing to attempt rhythm control.

Exclusion criteria

Unable to consent
A personal or family history of medullary thyroid carcinoma
A personal or family history of multiple endocrine neoplasia syndrome type 2
History of allergic reaction to Semaglutide or any of its components
Currently pregnant or planning to become pregnant
Currently breastfeeding
History of acute pancreatitis
History of pancreatic adenocarcinoma
Previous or current GLP-1 RA use
Previous or current use of alternative pharmacologic weight loss agents (phentermine, diethylpropion, orlistat, phentermine-topiramate, bupropion- naltrexone, gelesis100, or setmelanotide)
Unable to tolerate anticoagulation
History of bariatric surgery

Endpoints (14)

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

Weight & body composition
3
Cardiometabolic biomarkers
3
Other clinical outcomes
3
Other (unclassified)
2
Cardiovascular outcomes
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Atrial fibrillation burden

Time frame:52 weeks

percent change from baseline, improvement

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Epicardial adipose tissue

Time frame:52 weeks

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Weight change

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Fat depots

Time frame:52 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change in C-reactive Protein (CRP)

Time frame:52 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Blood pressure

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Interleukin-6 (IL-6)

Time frame:52 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Quality of life on Healthcare Quality of Life surverys

Time frame:52 weeks

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adherence and Adverse Events

Time frame:52 weeks

Treatment-emergent AEs (any)

descriptive

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint

Sleep apnea

Time frame:52 weeks

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Participation in VA MOVE

Time frame:52 weeks

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Change in AF burden for four weeks

Time frame:52 weeks

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Left atrial function

Time frame:52 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Left atrial size and function

Time frame:52 weeks

change from baseline, improvement

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.