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HomeTrials › NCT06499857

Obesity & weight · Phase 3 · Recruiting now

Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation

NCT06499857 · Sponsor: University of Chicago

What this trial means for you

This study is recruiting now at 2 US sites. It's studying Semaglutide, Placebo for overweight or obesity, atrial fibrillation.

Who can joinAll sexes, 18 Years – 75 Years
Healthy volunteersNo — diagnosis required
What you'd takeSemaglutide, Placebo
Study length~2.7 years overall
Planned participants200
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

The goal of the study is to learn how a weight loss medication called semaglutide, which is used to treat obesity, in addition to standard AF treatment might affect AF, atrial fibrillation severity, and whether it changes the risk of atrial fibrillation recurring after standard AF treatments.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Arizona

  • The University of Arizona College of Medicine- Phoenix — Phoenix · Opening soon

Illinois

  • University of Chicago — Chicago · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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