Olpasiran for Cardiovascular Disease

Recruiting in Palo Alto (17 mi)

+840 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing olpasiran, a medication that may reduce heart risks, in patients with heart disease and high levels of a specific type of fat called Lipoprotein(a). By lowering this fat, olpasiran aims to prevent heart attacks and other serious heart problems. Inclisiran is another emerging drug targeting LDL cholesterol, similar to olpasiran's focus on reducing lipoprotein(a).

Eligibility Criteria

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 am between 18 and 85 years old.

See 2 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

Treatment Details

Interventions

Olpasiran (Antisense Oligonucleotide)
Placebo (Drug)

Trial OverviewThe 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.

Participant Groups

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