406 Participants NeededMy employer runs this trial

Olpasiran for Cardiovascular Disease

(OCEAN(a)-CCTA Trial)

Recruiting at 39 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called olpasiran to determine if it can reduce the buildup of non-calcified plaque in the arteries of people with heart disease. The researchers aim to compare the effects of olpasiran, administered as an injection every 12 weeks, with a placebo (a non-active substance). Suitable candidates for this trial have heart disease, high levels of Lp(a) (a specific type of cholesterol), and a history of heart attacks or certain heart procedures. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that olpasiran is likely to be safe for humans?

Research has shown that olpasiran is generally safe and well-tolerated. Studies have found that side effects are uncommon, and most participants did not experience serious problems while taking the treatment. In earlier studies, researchers tested the drug on individuals with heart issues and successfully lowered lipoprotein(a), a type of cholesterol linked to heart disease.

Reports indicate that even higher doses of olpasiran did not cause serious side effects. Ongoing research will provide more information, but current evidence suggests it is a promising option for those with heart concerns.12345

Why do researchers think this study treatment might be promising?

Olpasiran is unique because it targets lipoprotein(a), a specific type of cholesterol linked to cardiovascular disease, which current treatments usually overlook. Most available therapies, like statins, primarily focus on lowering LDL cholesterol, but they don't effectively address high levels of lipoprotein(a). Researchers are excited about olpasiran because it offers a new mechanism of action by potentially reducing this specific cholesterol component, providing an innovative option for patients at risk of heart disease. Additionally, olpasiran is administered subcutaneously once every 12 weeks, offering a convenient dosing schedule compared to daily oral medications.

What evidence suggests that olpasiran might be an effective treatment for cardiovascular disease?

Research has shown that olpasiran, which participants in this trial may receive, can significantly lower lipoprotein(a) levels, a type of cholesterol linked to heart disease. In studies, olpasiran reduced lipoprotein(a) by over 95% in people with heart conditions and also decreased other harmful cholesterol types, such as LDL, often called "bad cholesterol." Even after stopping the treatment, patients who took olpasiran experienced a 40% to 50% reduction in lipoprotein(a). These findings suggest that olpasiran could help manage heart conditions by targeting specific cholesterol types.14567

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults aged 35 to 80 who have high levels of lipoprotein(a), a history of heart attack or certain heart procedures, and signs of coronary artery disease on a special heart scan.

Inclusion Criteria

My Lp(a) levels are 200 nmol/L or higher.
I have had a heart attack or a procedure to open my heart's arteries.
My heart scan shows blockage in a major artery.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olpasiran or placebo subcutaneously every 12 weeks

12 weeks
1 visit every 12 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Olpasiran

Trial Overview

The study compares olpasiran, an experimental drug that lowers lipoprotein(a), with a placebo. Participants are randomly assigned to receive either the drug or placebo, and changes in artery plaque are measured using CT scans.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: OlpasiranExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

Small Interfering RNA to Reduce Lipoprotein(a) in ...

Olpasiran therapy significantly reduced lipoprotein(a) concentrations in patients with established atherosclerotic cardiovascular disease.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41879443

Lowering of Lipoprotein(a) with Olpasiran

A phase 3 outcomes trial is currently underway. In this review article, we delve further into lowering of Lp(a) with Olpasiran by detailing its ...

An RNA Inhibitor Effectively Reduces a High-Risk Type of ...

The study reported that higher doses of olpasiran lowered the type of cholesterol called lipoprotein(a) [Lp(a)] by more than 95 percent in ...

Olpasiran Trials of Cardiovascular Events and Lipoprotein ...

The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD ...

Abstract 4348302: Olpasiran Outperforms Other ...

Conclusions: Among Lp(a)-targeted therapies, olpasiran showed the largest Lp(a), LDL-C, ApoB, and ACM lowering effects, ranking better than ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39168564/

The Off-Treatment Effects of Olpasiran on Lipoprotein(a) ...

Participants receiving doses ≥75 mg Q12W sustained a ∼40% to 50% reduction in Lp(a) levels close to 1 year after the last dose. (Olpasiran ...

Olpasiran Trials of Cardiovascular Events and Lipoprotein ...

The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD ...