What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease that focus on lowering LDL cholesterol, such as statins and PCSK9 inhibitors, have well-documented side effects. Statins can cause muscle pain, liver enzyme abnormalities, and rarely, rhabdomyolysis. PCSK9 inhibitors, like alirocumab and evolocumab, are generally well-tolerated but may cause injection site reactions, hypersensitivity reactions, and rare neurocognitive issues. Other lipid-lowering therapies, such as ezetimibe and bempedoic acid, may cause gastrointestinal issues and elevated liver enzymes.

What prior FDA approvals exist?

The FDA has approved several treatments for cardiovascular disease that focus on lowering LDL cholesterol levels. Statins, such as atorvastatin and rosuvastatin, are widely used and have been shown to reduce cardiovascular events and mortality. PCSK9 inhibitors, including alirocumab and evolocumab, are another class of drugs that significantly lower LDL cholesterol and have demonstrated clinical benefits in reducing the rates of stroke and myocardial infarction. Additionally, inclisiran, a small interfering RNA, has been approved for its ability to lower LDL cholesterol by inhibiting PCSK9 synthesis. These treatments are particularly relevant for patients who are not adequately controlled with traditional lipid-lowering therapies.

What other types of research exist?

Promising novel alternatives for LDL cholesterol reduction in cardiovascular disease patients include PCSK9 inhibitors (e.g., evolocumab and alirocumab), which have shown significant efficacy in lowering LDL-C levels and reducing cardiovascular events. Another emerging option is inclisiran, a small interfering RNA (siRNA) therapy that provides sustained LDL-C reduction with biannual dosing. Additionally, CETP inhibitors like obicetrapib are being investigated for their potential to increase HDL-C and lower LDL-C levels. These therapies offer new avenues for patients who are not adequately controlled with traditional lipid-lowering treatments.

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Cholesteryl Ester Transfer Protein (CETP) Inhibitor

Obicetrapib for Cardiovascular Disease (PREVAIL Trial)

Phase 3

Waitlist Available

Research Sponsored by NewAmsterdam Pharma

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 30 months after last participant randomized

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called Obicetrapib to help people with heart disease who still have high cholesterol despite taking strong treatments. The goal is to see if this medication can lower their risk of heart attacks, strokes, and other serious heart problems by reducing bad cholesterol levels.

Who is the study for?

This trial is for adults with cardiovascular disease who are already on the highest dose of cholesterol-lowering meds they can handle, but still have high LDL (bad) cholesterol. They should not be in advanced heart failure, have had recent serious heart events or cancer treatments, uncontrolled blood pressure, severe liver issues, or a history of substance abuse.

What is being tested?

The study tests Obicetrapib against a placebo to see if it's better at managing cardiovascular risks when added to standard therapy. Participants won't know which one they're getting as it's randomly decided and kept secret even from the doctors (double-blind).

What are the potential side effects?

While specific side effects for Obicetrapib aren't listed here, common ones for drugs like this include headache, muscle pain, digestive problems, and possible liver enzyme changes. Side effects vary by individual.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months after last participant randomized

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months after last participant randomized

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months after last participant randomized for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Major Adverse Cardiovascular Effect (MACE)

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT04753606

Inflammation

Tendonitis

Temporomandibular joint syndrome

Lumbar spinal stenosis

Arthralgia

Somnolence

Arthropod sting

Glaucoma

Renal impairment

Headache

Cardiomegaly

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Obicetrapib 10 mg

Obicetrapib 5 mg

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: obicetrapib 10mgExperimental Treatment1 Intervention

one 10mg tablet, once daily.

Group II: PlaceboPlacebo Group1 Intervention

one placebo tablet, once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obicetrapib

Not yet FDA approved

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 focus on lowering low-density lipoprotein cholesterol (LDL-C) due to its significant role in atherosclerosis. Statins, the most widely used lipid-lowering drugs, inhibit HMG-CoA reductase, an enzyme crucial for cholesterol synthesis in the liver, thereby reducing LDL-C levels. PCSK9 inhibitors, such as alirocumab and evolocumab, work by inhibiting the PCSK9 protein, which leads to increased recycling of LDL receptors and enhanced clearance of LDL-C from the bloodstream. These treatments are vital for CVD patients as they help reduce the risk of adverse cardiovascular events like myocardial infarction and stroke by managing cholesterol levels and slowing the progression of atherosclerosis.