What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease that modulate metabolic pathways include statins, ezetimibe, and combination therapies like colestipol-niacin. Statins are known to cause muscle pain, liver enzyme abnormalities, and, rarely, myopathy or rhabdomyolysis. Ezetimibe is generally well-tolerated but can cause gastrointestinal issues and, in rare cases, myopathy. Combination therapies like colestipol-niacin can lead to gastrointestinal discomfort, flushing, and liver enzyme abnormalities. These treatments aim to lower LDL cholesterol and improve cardiovascular outcomes but come with a risk of these side effects.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of cardiovascular disease work by modulating metabolic pathways to reduce cardiovascular risk. Statins, such as atorvastatin, lower cholesterol levels and have anti-inflammatory effects, reducing the risk of myocardial infarction and stroke. Biguanides, like metformin, improve insulin sensitivity and lower blood glucose levels, indirectly benefiting cardiovascular health. Additionally, acetylsalicylic acid (ASA) is used for its antiplatelet properties to prevent blood clots. These treatments share mechanisms involving lipid-lowering, anti-inflammatory, and glucose-modulating effects, similar to the investigational drug CagriSema.

What other types of research exist?

Promising novel alternatives to CagriSema for CVD patients include: 1) Newer, more potent cholesterol-lowering agents that significantly reduce LDL cholesterol levels, 2) Investigational therapies targeting atherosclerosis, such as agents modifying inflammatory pathways, cartilage catabolism, and bone remodeling, and 3) Emerging treatments like monoclonal antibodies targeting specific metabolic pathways involved in atherogenesis and thromboembolic events. These therapies aim to stabilize atherosclerotic plaques and reduce cardiovascular events.

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Amylin Analog

CagriSema for Cardiovascular Disease (REDEFINE 3 Trial)

Phase 3

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week -3) to end of study (up to 242 weeks or more)

Awards & highlights

Pivotal Trial

Summary

This trial will test if CagriSema can reduce heart attacks and strokes in people with cardiovascular disease. Participants will inject CagriSema regularly over several years. The goal is to see if CagriSema can improve heart health.

Who is the study for?

This trial is for people aged 55 or older with a history of heart attack, stroke, or cardiovascular disease (CVD), and a BMI of at least 30. If they have type 2 diabetes (T2D), they must be diagnosed for over 180 days and meet specific CVD criteria. Excluded are those on dialysis, with recent severe cardiac events, end-stage renal disease, or who've used certain diabetes drugs recently.

What is being tested?

The study tests the effects of CagriSema versus placebo on preventing heart attacks and strokes in individuals with cardiovascular issues. Participants will receive either the actual drug or placebo by injection once weekly at random. The trial aims to last up to four and a half years.

What are the potential side effects?

While not specified here, common side effects for medications like Cagrilintide and Semaglutide may include nausea, diarrhea, weight loss, low blood sugar levels in diabetics; however individual experiences can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week -3) to end of study (up to 242 weeks or more)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week -3) to end of study (up to 242 weeks or more)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -3) to end of study (up to 242 weeks or more) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke

Secondary study objectives

Change from baseline in Interleukin 1 beta (IL-1β)

Change from baseline in Interleukin 6 (IL-6)

Change from baseline in high-sensitivity C-reactive protein (hsCRP)

+22 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

Experimental Treatment

Placebo Group

Group I: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions

Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly after a dose escalation period of 16 weeks during the maintenance period of 219 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

Cagrilintide

2023

Completed Phase 1

~150

Do I qualify?Apply below to find out

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 cardiovascular disease (CVD) often target metabolic pathways to reduce cardiovascular risk. Statins, for example, inhibit HMG-CoA reductase, lowering LDL cholesterol and exerting anti-inflammatory effects on the endothelium. Antiplatelet agents like aspirin prevent thrombus formation by inhibiting platelet aggregation. ACE inhibitors and ARBs reduce blood pressure and mitigate heart strain by blocking the renin-angiotensin-aldosterone system. Newer treatments, such as GLP-1 receptor agonists and SGLT2 inhibitors, improve glycemic control and have shown cardiovascular benefits by reducing inflammation and oxidative stress. These mechanisms are crucial for CVD patients as they address underlying risk factors, prevent disease progression, and reduce the incidence of acute cardiovascular events.

New possible pharmacological targets for statins and ezetimibe.Inflammation and its resolution as determinants of acute coronary syndromes.Expression of c-fos, p53 and PCNA in the unstable atherosclerotic carotid plaque.