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Anti-obesity Agent

Semaglutide for Atrial Fibrillation (SEMINAL-AF Trial)

Phase 3

Waitlist Available

Led By Silvana Pannain, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-75 years

- The subject is taking basal insulin only or oral hypoglycemic agents or a combination of those

Must not have

Current use of prandial insulin

History of type I diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 68

Awards & highlights

Pivotal Trial

Summary

"This trial aims to see how a weight loss medication called semaglutide, when combined with standard treatment for atrial fibrillation (AF), can impact AF severity and the risk of it coming back

Who is the study for?

This trial is for individuals with obesity and atrial fibrillation (AF), a type of irregular heartbeat. Participants should be seeking treatment for AF and are interested in how weight loss might affect their condition.

What is being tested?

The study is testing the effects of semaglutide, a medication used for weight loss, on patients with AF. It aims to see if this drug, alongside standard AF treatments, can reduce the severity of AF or prevent it from coming back.

What are the potential side effects?

Semaglutide may cause digestive issues like nausea or constipation, increase heart rate, and there's a potential risk of thyroid tumors. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I am on basal insulin, oral diabetes medications, or both.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using mealtime insulin.

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I have a history of type I diabetes.

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My kidney function is severely reduced.

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I currently have cancer.

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I have a history of chronic pancreatitis.

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I or someone in my family has had medullary thyroid cancer or MEN 2.

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I have had weight loss surgery in the past.

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I am on medication to suppress my immune system due to chronic inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 68

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 68

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 68 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in AF burden detected by routine outpatient monitoring.

Time to first AF event detected by routine outpatient monitoring

Secondary study objectives

Change in Autonomic tone as determined by heart rate variability

Change in LV (left ventricular) myocardial fibrosis

Change in epicardial and/or pericardial adipose tissue volume

+13 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SemaglutideActive Control1 Intervention

Participants will have a 2 in 3 chance of receiving semaglutide (2.4 mg).

Group II: PlaceboPlacebo Group1 Intervention

Participants will have a 1 in 3 chance of receiving placebo.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,047 Previous Clinical Trials

758,373 Total Patients Enrolled

15 Trials studying Obesity

1,985 Patients Enrolled for Obesity

Silvana Pannain, MDPrincipal InvestigatorUniversity of Chicago

2 Previous Clinical Trials

24 Total Patients Enrolled

1 Trials studying Obesity

16 Patients Enrolled for Obesity

~133 spots leftby Dec 2027

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