Olpasiran for Cardiovascular Disease
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.12345Why 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).14678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous olpasiran or placebo to evaluate the effect on cardiovascular events
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
Participants will receive subcutaneous (SC) olpasiran.
Participants will receive SC placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
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
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), ...
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) ...
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 ...
Small Interfering RNA to Reduce Lipoprotein(a) in ...
Olpasiran therapy significantly reduced lipoprotein(a) concentrations in patients with established atherosclerotic cardiovascular disease.
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 ...
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).
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 ...
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 ...
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