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New treatment option for Overweight or Obesity
Official title Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
ClinicalTrials.gov ID: NCT06499857
What this study is testing
What is Semaglutide?
Semaglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight or obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years
- BMI greater than or equal to 30 kg/m2
- 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...
- Ability to provide informed consent before any trial-related activities.
- Patients with type 2 diabetes mellitus (T2DM) will be included:
You likely can't join if
- 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...
- Current antiobesity medication use or use within the last 90 days prior to screening
- A self-reported change in body weight of \> 5 kg (11 lb.) within 30 days before screening
- History of bariatric surgery
- History of type I diabetes mellitus
- Current use of prandial insulin
See the full eligibility criteria
- Age 18-75 years
- BMI greater than or equal to 30 kg/m2
- 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)
- Ability to provide informed consent before any trial-related activities.
- Patients with type 2 diabetes mellitus (T2DM) will be included:
- If HbA1c (glycated hemoglobin) is less than or equal to 10 %
- If the subject is taking basal insulin only or oral hypoglycemic agents or a combination of those.
- 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
- 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...
- 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 \ 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...
- 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
- Current antiobesity medication use or use within the last 90 days prior to screening
- A self-reported change in body weight of \> 5 kg (11 lb.) within 30 days before screening
- History of bariatric surgery
- History of type I diabetes mellitus
- Current use of prandial insulin
- Hospitalization for unstable angina, or TIA (Transient ischemic attack) \< 30 days prior to screening
- Pulmonary embolism \< 90 days before screening
- MI (myocardial infarction), stroke, etc. \< 90 months prior to screening
- 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
- Active malignancy
- Active enrollment in another investigational study that includes any kind of intervention
- The receipt of any investigational drug within 90 days prior to this trial.
- Inability to comply with study procedures
- Acute pancreatitis \< 180 days before screening
- History or presence of chronic pancreatitis
- CKD (Chronic Kidney Disease) stage 4 (GFR \<30 ml/min)
- A personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY
- Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids
- Previous participation in this trial (received at least one dose of study drug or placebo)
- Pregnant, breast-feeding or planning pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.