Olpasiran for Cardiovascular Disease

Recruiting at 161 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Prior atherothrombotic event, Revascularization, Bleeding disorder

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 6.2 years

11000 Participants Needed

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 risk of major heart problems, such as heart attacks, in individuals with high levels of lipoprotein(a), a blood fat linked to heart disease. Participants will receive either the experimental drug olpasiran or a placebo (a harmless pill resembling the drug) to compare their effects. The trial is suitable for those aged 50 or older with high levels of lipoprotein(a) and other heart disease risk factors who have not experienced a major heart event like a heart attack or stroke. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking heart disease treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether 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 well-tolerated. In one study, olpasiran significantly reduced levels of lipoprotein(a), which is linked to heart disease. This finding is promising, as it suggests the drug works effectively without causing serious issues.

In earlier research, some participants experienced side effects, usually mild. These included reactions at the injection site, such as redness or swelling, and some reported flu-like symptoms. However, no major safety concerns emerged.

Since this trial is in a later stage, olpasiran has already passed initial safety tests, adding confidence in its safety for participants. It remains important to review all information and consult a healthcare provider when considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Olpasiran is unique because it targets lipoprotein(a), a specific type of cholesterol that has been hard to manage with existing treatments like statins or PCSK9 inhibitors. Unlike the standard of care, which generally focuses on lowering LDL cholesterol, Olpasiran works by significantly reducing lipoprotein(a) levels, potentially lowering the risk of cardiovascular events. Researchers are excited about Olpasiran as it offers a new approach to heart health, providing hope for patients who haven't found success with existing therapies.

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 effectively lower lipoprotein(a) [Lp(a)], a type of cholesterol linked to heart problems. In one study, higher doses of olpasiran reduced Lp(a) levels by more than 95%. Patients who previously took olpasiran experienced a significant drop in Lp(a) levels, indicating promise for lowering heart disease risks. These findings suggest that olpasiran might help reduce the risk of major heart issues, like heart attacks, by targeting Lp(a). ^{1 4 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for individuals aged 50 or older who are at risk of a first major heart event and have high levels of lipoprotein(a), a type of fat in the blood. They should also have multiple risk factors for heart disease or signs of atherosclerosis but no history of acute heart events, bleeding disorders, or past/planned artery-clearing procedures.

Inclusion Criteria

I am 50 years old or older.

Lp(a)≥ 200 nmol/L during screening

I have risk factors for heart disease or signs of atherosclerosis.

Exclusion Criteria

I have had a heart attack, stroke, or similar event before.

I have a history of a major bleeding disorder.

I have had or am planning to have surgery to restore blood flow in my arteries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous olpasiran or placebo to evaluate the effect on cardiovascular events

Up to approximately 6.2 years

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 aims to see if Olpasiran can reduce the chance of death from coronary heart disease, heart attacks, or urgent need for artery-clearing procedures compared to a placebo in people with elevated lipoprotein(a) who haven't had major cardiovascular events before.

How Is the Trial Designed?

Group I: Olpasiran Experimental Treatment 1 Intervention

Participants will receive subcutaneous (SC) olpasiran.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive SC placebo.

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

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05581303

Olpasiran Trials of Cardiovascular Events and Lipoprotein ... The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2024.05.058

The Off-Treatment Effects of Olpasiran on Lipoprotein(a) ... Olpasiran is a potent siRNA with prolonged effects on Lp(a) lowering. Participants receiving doses ≥75 mg Q12W sustained a ∼40% to 50% reduction in Lp(a) ...

3. mountsinai.org mountsinai.org/about/newsroom/2025/an-rna-inhibitor-may-effectively-reduce-a-high-risk-type-of-cholesterol-in-patients-with-cardiovascular-disease

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 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2211023

Small Interfering RNA to Reduce Lipoprotein(a) in ... Olpasiran therapy significantly reduced lipoprotein(a) concentrations in patients with established atherosclerotic cardiovascular disease.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149291825002644

An Open-Label, Single-Dose Study to Evaluate the ... Cardiovascular disease (CVD) remains a major cause of premature mortality and disability worldwide, with China ranking among the highest in ...

6. amgen.com amgen.com/newsroom/press-releases/2023/08/amgen-presents-late-breaking-phase-2-olpasiran-data-at-esc-2023

Press Releases Amgen (NASDAQ:AMGN) today announced data from the final analysis of the Phase 2 OCEAN(a)-DOSE study of olpasiran, a small interfering RNA (siRNA).

7. amgentrials.com amgentrials.com/study/?id=20180244

Olpasiran Trials of Cardiovascular Events and Lipoprotein ... The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460541/

implications for the OCEAN(a)-outcomes trial population - PMC The recent OCEAN(a)-DOSE trial demonstrated that olpasiran significantly reduced Lp(a) concentrations in patients with established ASCVD. As a ...