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Weight-Loss drug semaglutide takes on atrial fibrillation in new trial

NCT ID NCT06499857

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether semaglutide, a medication used for weight loss, can help control atrial fibrillation (AFib) in people who are overweight or have obesity. About 200 adults aged 18-75 with AFib and a BMI of 30 or higher will receive semaglutide plus standard AFib care. Researchers will monitor how long it takes for AFib to return and how much time participants spend in AFib, along with changes in weight and heart fat.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-75 years 2. BMI greater than or equal to 30 kg/m2 3. 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) 4. Ability to provide informed consent before any trial-related activities. 5. Patients with type 2 diabetes mellitus (T2DM) will be included: 1. If HbA1c (glycated hemoglobin) is less than or equal to 10 % 2. If the subject is taking basal insulin only or oral hypoglycemic agents or a combination of those. 3. Patients on SGLT2-inhibitors and TZDs (Thiazolidinedione) will be included if they have been on a stable dose of these medications for at least 6 months 4. The following protocol will be adopted to adjust insulin secretagogues (sulfonylureas or meglitinides) and insulin during the study (adapted from the Look Ahead Study). Patients will be asked to check their blood glucose (BG) 4 x day (before meals and at bed time) during the dose escalation and dose stabilization phases (weeks 0 to 20) and recommendation of dose adjustments will be immediately sent to their treating physician according to the dose adjustment scale below: * 2 blood sugars \<100 mg/dl- reduce meds \[insulin secretagogues (sulfonylureas or meglitinides) and basal insulin\] by 0-50 % * 3 blood sugars 80-100 mg/dl- reduce meds \[insulin secretagogues (sulfonylureas or meglitinides) and basal insulin\] by 25-75% * 3 blood sugars \<80 mg/dl \> 2 x week or severe hypoglycemia or symptomatic hypoglycemia- reduce meds \[insulin secretagogues (sulfonylureas or meglitinides) and basal insulin\] by 50-100 % Randomization to treatment (active and placebo) will be stratified to balance patients with T2DM across the study arms. After completion of the trial a prespecified subgroup analysis of the patients enrolled affected by T2DM will be performed. For women of child-bearing potential, use of appropriate contraception will be required. In patients that are prescribed amiodarone, standard care practices will be implemented to evaluate for liver and thyroid side effects with baseline liver and thyroid function tests via blood draw and evaluation every 6 months. Exclusion Criteria: 1. 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 2. Current antiobesity medication use or use within the last 90 days prior to screening 3. A self-reported change in body weight of \> 5 kg (11 lb.) within 30 days before screening 4. History of bariatric surgery 5. History of type I diabetes mellitus 6. Current use of prandial insulin 7. Hospitalization for unstable angina, or TIA (Transient ischemic attack) \< 30 days prior to screening 8. Pulmonary embolism \< 90 days before screening 9. MI (myocardial infarction), stroke, etc. \< 90 months prior to screening 10. Uncontrolled thyroid disease: TSH (Thyroid-stimulating hormone) \> 10.0 mIU/L (Milli-international Units Per Liter) or \< 0.4 mIU/L (Milli-international Units Per Liter) at screening 11. Active malignancy 12. Active enrollment in another investigational study that includes any kind of intervention 13. The receipt of any investigational drug within 90 days prior to this trial. 14. Inability to comply with study procedures 15. Acute pancreatitis \< 180 days before screening 16. History or presence of chronic pancreatitis 17. CKD (Chronic Kidney Disease) stage 4 (GFR \<30 ml/min) 18. A personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 19. A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY 20. Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids 21. Previous participation in this trial (received at least one dose of study drug or placebo) 22. Pregnant, breast-feeding or planning pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Arizona College of Medicine- Phoenix

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85004, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

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