Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

Olpasiran for Cardiovascular Disease

Not currently recruiting at 1027 trial locations

Overseen ByAmgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Severe renal dysfunction, Hemorrhagic stroke, Major bleeding disorder, others

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 risk of heart-related problems, such as heart attacks, in individuals with atherosclerotic cardiovascular disease (ASCVD) and high levels of Lipoprotein(a). The trial compares olpasiran to a placebo (an inactive substance) to assess effectiveness. Suitable candidates for this trial have a history of heart issues, such as a heart attack or a procedure to open blocked heart arteries, and elevated Lipoprotein(a) levels. Participants will receive the treatment through an injection under the skin. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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 appears safe and generally well-tolerated. In earlier studies, patients receiving higher doses of olpasiran did not report major safety issues and experienced a significant drop in lipoprotein(a), a substance linked to heart problems.

Although this trial is in a later stage, which usually provides more safety information, the final results will offer the most complete understanding. Ongoing research will continue to assess its safety and effectiveness in reducing heart-related risks.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about Olpasiran for cardiovascular disease because it targets lipoprotein(a) specifically, which is a different approach from many current treatments that mainly focus on lowering LDL cholesterol. Olpasiran is administered through a subcutaneous injection, providing a unique delivery method compared to oral medications. This targeted action could potentially offer a new way to manage cardiovascular risk for patients who don't respond well to conventional 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, is promising in lowering lipoprotein(a) [Lp(a)], a type of bad cholesterol linked to heart disease. Studies have found that olpasiran can reduce Lp(a) levels by over 95% in some cases. Specifically, previous patients who received olpasiran experienced a 40% to 50% drop in Lp(a) levels. This significant reduction in Lp(a) is expected to lower the risk of heart problems, such as heart attacks. So far, these studies have not identified any major safety concerns.² ³ ⁶ ⁷ ⁸

Who Is on the Research Team?

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 85 with a history of heart-related issues like myocardial infarction or stent procedures, plus one additional risk factor. They must have high levels of Lipoprotein(a) in their blood. People with severe kidney problems, certain liver conditions, bleeding disorders, planned heart surgeries, severe heart failure, or those who've had specific RNA treatments can't participate.

Inclusion Criteria

I have had a heart attack or surgery to open my heart's arteries and have at least one other heart risk factor.

Your Lp(a) level is higher than 200 nmol/L during screening.

I have had a heart attack or stent placement and have at least one other risk factor.

See 1 more

Exclusion Criteria

I have severe heart failure.

I have severe kidney problems.

I have had a bleeding stroke in the past.

See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either olpasiran or placebo administered by subcutaneous injection

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

Olpasiran
Placebo

Trial Overview The study aims to see if Olpasiran can reduce the risk of death from coronary disease and other serious heart events compared to a placebo in people with cardiovascular disease and high Lipoprotein(a). Participants are randomly assigned to receive either Olpasiran or a placebo.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OlpasiranExperimental Treatment1 Intervention

Olpasiran will be administered by subcutaneous injection

Group II: PlaceboPlacebo Group1 Intervention

Placebo will be administered by subcutaneous injection

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

Published Research Related to This Trial

New angiotensin receptor blockers (ARBs) like telmisartan and olmesartan are effective antihypertensive medications that not only lower blood pressure but also provide additional cardiovascular benefits, such as improving endothelial function and reducing inflammation.

Telmisartan is specifically indicated for cardiovascular prevention in high-risk patients, and olmesartan may help slow atherosclerosis progression and delay kidney issues, potentially leading to better cardiovascular outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angiotensin receptor blockers - advantages of the new sartans.Sabbah, ZA., Mansoor, A., Kaul, U.[2018]

Citations

1.clinicaltrials.govclinicaltrials.gov/study/NCT05581303

Study Details | NCT05581303 | Olpasiran ...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.orgjacc.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.orgmountsinai.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.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40772726/

Advances in RNA-Based Therapies Targeted at ...The OCEAN(a)-DOSE phase 2 trial showed profound and sustained reductions in Lp(a) with the use of olpasiran, with no significant safety concerns ...

5.nejm.orgnejm.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.

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

Press ReleasesThe results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo- ...

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

8.amgentrials.comamgentrials.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 death), ...

Other People Viewed

By Subject

By Trial