RECRUITING

Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation

Conditions

Overweight or Obesity Atrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation

Quick Facts

Study Start:2025-04-14

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06499857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). * 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 %	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

Inclusion Criteria

Exclusion 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).
* 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 %

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

Contacts and Locations

Study Contact

Silvana Pannain, MD

CONTACT

773-702-3275

spannain@bsd.uchicago.edu

Andrew Beaser, MD

CONTACT

773-702-9324

abeaser@bsd.uchicago.edu

Principal Investigator

Silvana Pannain, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

The University of Arizona College of Medicine- Phoenix

Phoenix, Arizona, 85004

United States

University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Silvana Pannain, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14

Study Completion Date2028-06

Study Record Updates

Study Start Date2025-04-14

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Overweight or Obesity
Atrial Fibrillation