What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as liraglutide and exenatide, are commonly used in the treatment of type 2 diabetes and have shown cardiovascular benefits. Common side effects include gastrointestinal symptoms like nausea, vomiting, and diarrhea. There are also concerns about potential risks of pancreatitis and thyroid C-cell tumors, although these are rare. Other cardiovascular treatments, such as statins, may cause muscle pain, liver enzyme abnormalities, and an increased risk of diabetes. Antiplatelet agents like aspirin can lead to gastrointestinal bleeding and ulcers.

What prior FDA approvals exist?

Several GLP-1 receptor agonists have been approved by the FDA for the treatment of type 2 diabetes mellitus, and some have shown cardiovascular benefits. Liraglutide (Victoza) was approved for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Similarly, semaglutide (Ozempic) has been approved for improving glycemic control and has demonstrated cardiovascular benefits. These drugs work by stimulating glucose-dependent insulin release, slowing gastric emptying, and regulating postprandial glucagon, which can contribute to improved cardiovascular outcomes.

What other types of research exist?

Promising alternatives to Retatrutide for cardiovascular disease patients include: <ol> <li>Evinacumab: A monoclonal antibody targeting ANGPTL3, shown to significantly reduce LDL-C levels in patients with homozygous familial hypercholesterolemia.</li> <li></li> </ol> GLP-1 Receptor Agonists: Other GLP-1 receptor agonists like liraglutide and dulaglutide, which have demonstrated cardiovascular benefits in type 2 diabetes patients. 3. Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors: These have shown cardiovascular benefits in patients with type 2 diabetes and may be considered as an alternative.

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Peptide

Retatrutide for Obesity and Cardiovascular Disease (TRIUMPH-3 Trial)

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Have established cardiovascular (CV) disease with at least 1 of the following: prior myocardial infarction, prior ischemic or hemorrhagic stroke, or symptomatic peripheral arterial disease

Be older than 18 years old

Must not have

Have a prior or planned surgical treatment of obesity

Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 80

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called retatrutide in people who have both obesity and heart disease. The study will last over two years to see if the medication is safe and effective.

Who is the study for?

This trial is for adults with obesity (BMI ≥35) and a history of cardiovascular disease, such as heart attack, stroke, or arterial disease. Participants should have tried to lose weight unsuccessfully before. They can't join if they've had recent significant weight changes, certain surgeries or acute cardiovascular events, use of weight loss drugs within the last 90 days, Type 1 diabetes, or specific hereditary cancer syndromes.

What is being tested?

The study tests Retatrutide's effectiveness and safety in reducing body weight for those with obesity and CVD. It compares Retatrutide given weekly against a placebo over approximately 113 weeks to see which is better at managing these conditions.

What are the potential side effects?

While the side effects are not detailed here, similar medications often cause digestive issues like nausea or diarrhea; injection site reactions; low blood sugar levels; increased heart rate; headache; fatigue; allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have heart disease, including a past heart attack, stroke, or symptoms of poor blood flow in my legs.

Exclusion Criteria

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

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I have had or am planning to have surgery for weight loss.

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I have lost or gained more than 11 pounds in the last 3 months.

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I or my family have a history of MTC or MEN-2.

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I have had pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 80

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 80

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 80 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Change from Baseline in Body Weight

Secondary study objectives

Change from Baseline in Body Mass Index (BMI)

Change from Baseline in Diastolic Blood Pressure (DBP)

Change from Baseline in Hemoglobin A1c (HbA1c)

+7 more

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Retatrutide Dose 2Experimental Treatment1 Intervention

Participants will receive retatrutide SC.

Group II: Retatrutide Dose 1Experimental Treatment1 Intervention

Participants will receive retatrutide subcutaneously (SC).

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

0 / 5Eligibility 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

GLP-1 receptor agonists, such as liraglutide, work by mimicking the incretin hormone GLP-1, which increases insulin secretion, inhibits glucagon release, and slows gastric emptying, leading to improved blood glucose control and potential weight loss. These effects are beneficial for cardiovascular disease patients as they help manage diabetes and obesity, both of which are significant risk factors for CVD. Additionally, GLP-1 receptor agonists have been shown to reduce cardiovascular events in patients with type 2 diabetes. Other common treatments for CVD include statins, which lower cholesterol levels and reduce the risk of atherosclerosis, and antihypertensive medications, which manage blood pressure to prevent heart attacks and strokes. These treatments collectively help reduce the burden of cardiovascular disease by addressing its primary risk factors.

Cholesterol reduction and its impact on coronary artery disease and total mortality.Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke.Total cardiovascular events analysis of the EXAMINE trial in patients with type 2 diabetes and recent acute coronary syndrome.