What is the mechanism of action of this treatment?

Common treatments for Coronary Artery Disease (CAD) include GLP-1 agonists like Liraglutide, which reduce inflammation in epicardial adipose tissue (EAT) by decreasing pro-inflammatory cytokines, thereby lowering the risk of coronary plaques. This is crucial for CAD patients as inflammation significantly contributes to atherosclerosis progression. Other treatments include statins, which lower LDL cholesterol and reduce plaque formation; beta-blockers, which decrease heart rate and blood pressure, reducing myocardial oxygen demand; and antiplatelet agents like aspirin, which prevent blood clots. These treatments collectively aim to reduce atherosclerosis, prevent heart attacks, and improve cardiovascular health.

What side effects are associated with this type of intervention?

GLP-1 agonists, such as Liraglutide, used in the treatment of Coronary Artery Disease (CAD) by reducing epicardial adipose tissue (EAT) inflammation, can have several side effects. Commonly reported side effects include gastrointestinal issues like nausea, vomiting, and diarrhea. There is also a potential risk for pancreatitis and gallbladder disease. Additionally, there are concerns about the long-term risk of thyroid C-cell tumors, particularly in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia. Patients should discuss these risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Coronary Artery Disease (CAD), including GLP-1 receptor agonists like Liraglutide. Liraglutide has shown promise in reducing epicardial adipose tissue (EAT) inflammation by decreasing pro-inflammatory cytokines, which can help reduce the burden of coronary plaques. Other GLP-1 receptor agonists, such as Semaglutide and Exenatide, have also been studied for their cardiovascular benefits, including potential reductions in major adverse cardiovascular events (MACE) in patients with type 2 diabetes and CAD.

What other types of research exist?

Promising alternatives to Liraglutide for CAD patients include other GLP-1 receptor agonists such as Semaglutide and Dulaglutide, which have demonstrated cardiovascular benefits and anti-inflammatory properties. Additionally, Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitors like Empagliflozin and Canagliflozin have shown significant reductions in cardiovascular events and may be considered as novel alternatives.

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GLP-1 Agonist

Liraglutide for Coronary Heart Disease

Phase 4

Waitlist Available

Led By Gianluca Iacobellis, MD PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

T2DM as defined by American Diabetes Association (ADA) criteria

Adult patients with T2DM who are indicated to receive liraglutide, not as first-line therapy, in addition to diet and exercise to improve glycemic control

Must not have

Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)

Current use of other GLP-1A, dipeptidyl peptidase 4 (DPP4) or Sodium Glucose transporters 2 (SGLT2) inhibitors, thiazolidinediones (TZDs), pramlintide and fixed prandial insulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from a minimum of 4 weeks up to 12 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if liraglutide, a diabetes medication, can reduce heart fat inflammation in patients with type 2 diabetes and coronary artery disease. By lowering inflammation, it may help reduce artery plaque buildup. The study involves 40 patients who will receive liraglutide. Liraglutide is approved for the treatment of type 2 diabetes and obesity, with evidence showing it can reduce cardiovascular events.

Who is the study for?

This trial is for adults over 18 with stable coronary artery disease requiring bypass surgery and type 2 diabetes, with a BMI ≥27 or waist circumference ≥102 cm in men and ≥88 cm in women. Participants should have an HbA1c ≤9% and be on a stable diabetes regimen but not first-line therapy. Exclusions include those with serious hypersensitivity to liraglutide, pregnant or breastfeeding women, unstable CAD, certain other medical conditions, or using specific medications.

What is being tested?

The study tests if the drug Liraglutide can reduce inflammation in heart fat tissue among patients with type 2 diabetes and coronary artery disease undergoing bypass surgery. It's a randomized double-blind trial comparing Liraglutide against placebo over at least four weeks before surgery to see its effect on inflammatory genes within epicardial adipose tissue.

What are the potential side effects?

Liraglutide may cause side effects such as digestive issues (nausea, vomiting), potential pancreatitis risk, allergic reactions including rash or swelling of face/throat, thyroid tumors including cancer (rare), increased heart rate, kidney problems which might require dialysis.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with type 2 diabetes.

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I have type 2 diabetes and my doctor recommends liraglutide, not as my first treatment, to help control my blood sugar.

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I am 18 years old or older.

Exclusion Criteria

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

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I am using birth control as required.

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I am currently taking medication for diabetes that is not a fast-acting insulin.

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I have a history of medullary thyroid cancer or MEN2 in my family or myself.

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I have a history of serious health issues, including diabetes complications, organ transplants, or major organ diseases.

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I have no health conditions that make liraglutide unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from a minimum of 4 weeks up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from a minimum of 4 weeks up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from a minimum of 4 weeks up to 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

EAT inflammation

Secondary study objectives

EAT GLP-1R

EAT thickness

SAT inflammation

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: L-groupActive Control1 Intervention

• L-group will be started on liraglutide. Liraglutide will be started and administered for from a minimum of 4 weeks up to 12 weeks prior to CABG with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). The dose of 1.8 mg daily will be maintained until the end of the 12-week study. Other and current diabetes treatment will be continued

Group II: D-groupPlacebo Group1 Intervention

placebo will be administered in addition to current treatment prior to the CABG with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). D-group will be started on a supervised low calorie diet (LCD) to achieve approximately 5% of weight loss after from a minimum of 4 weeks up to 12 weeks.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include GLP-1 agonists like Liraglutide, which reduce inflammation in epicardial adipose tissue (EAT) by decreasing pro-inflammatory cytokines, thereby lowering the risk of coronary plaques. This is crucial for CAD patients as inflammation significantly contributes to atherosclerosis progression. Other treatments include statins, which lower LDL cholesterol and reduce plaque formation; beta-blockers, which decrease heart rate and blood pressure, reducing myocardial oxygen demand; and antiplatelet agents like aspirin, which prevent blood clots. These treatments collectively aim to reduce atherosclerosis, prevent heart attacks, and improve cardiovascular health.

Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial.The GLP-1 agonist, liraglutide, as a pharmacotherapy for obesity.Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, cross-over trial.