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Cardiovascular Disease

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  • Olpasiran

    phase 3

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Cardiovascular Disease

What is Cardiovascular Disease?

Cardiovascular disease refers to a group of disorders that affect the heart and blood vessels. It is often characterized by the accumulation of fatty deposits (atherosclerosis), inflammation, and other structural changes within the blood vessels, which can eventually lead to reduced blood flow, increased blood pressure, and impaired cardiac function.

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  • Cardiovascular disease is influenced by a combination of genetic, lifestyle, and environmental factors.
  • Atherosclerosis can narrow and stiffen arteries, restricting the flow of blood to vital organs such as the heart muscle or the brain. 
  • Non-lifestyle risk factors of cardiovascular disease primarily include genetics, age, and gender, with men being generally at higher risk than premenopausal women. 

1 in 5

U.S. deaths are related to heart disease

30.3MM

U.S. adults have a heart disease diagnosis

60%

Global surge in cardiovasular death over the past 30 years 

Our Research

Olpasiran

Cardiovascular Disease liver phase 3

Olpasiran, formerly AMG 890 and ARO-LPA, is designed to reduce production of apolipoprotein A, a key component of lipoprotein(a), which has been genetically linked with increased risk of cardiovascular diseases, independent of cholesterol and LDL levels.

Amgen acquired a worldwide, exclusive license in September 2016, to develop and commercialize olpasiran.

Clinical Trials

recruiting ID: NCT05581303

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), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

complete ID: NCT04270760

Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a) (OCEAN(a))

Cardiovascular Disease recruiting ID: NCT05581303

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), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

View on ClinicalTrials.gov

Inclusion Criteria

  • Age 18 to ≤ 85 years
  • Lp(a)≥ 200 nmol/L during screening
  • History of ASCVD as evidenced by history of either: Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor

Timeline

  • October 14, 2022

    Study First Posted

  • December 14, 2022

    Start Date

  • December 16, 2026

    End Date

Trial Details

Start date:

December 14, 2022

End date:

December 16, 2026

Locations:

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Taiwan, United Kingdom, United States

Participants:

6000

Eligibility criteria:

18 Years to 85 Years, All Sexes, No Healthy Volunteers

A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)

Cardiovascular Disease complete ID: NCT04270760

Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

View on ClinicalTrials.gov

Inclusion Criteria

  • Age 18 to 80 years
  • Lipoprotein (a) > 150 nmol/L
  • Evidence of atherosclerotic cardiovascular disease

Timeline

  • February 17, 2022

    Study First Posted

  • July 28, 2022

    Start Date

  • December 27, 2021

    Primary Completion

  • November 8, 2022

    End Date

Trial Details

Start date:

July 28, 2022

End date:

November 8, 2022

Locations:

Australia, Canada, Denmark, Iceland, Japan, Netherlands, United States

Participants:

281

Eligibility criteria:

18 Years to 80 Years, All Sexes, No Healthy Volunteers

Active Clinical Trials

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a) (OCEAN(a))

ALS recruiting ID: NCT05581303

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), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

View on ClinicalTrials.gov

Inclusion Criteria

  • Age 18 to ≤ 85 years
  • Lp(a)≥ 200 nmol/L during screening
  • History of ASCVD as evidenced by history of either: Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor

Timeline

  • October 14, 2022

    Study First Posted

  • December 14, 2022

    Start Date

  • December 16, 2026

    End Date

Trial Details

Start date:

December 14, 2022

End date:

December 16, 2026

Locations:

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Taiwan, United Kingdom, United States

Participants:

6000

Eligibility criteria:

18 Years to 85 Years, All Sexes, No Healthy Volunteers
recruiting

ALS ID: NCT05581303

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), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

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Compassionate Use

Learn more about our compassionate use agreement and eligibility criteria for medicines in our pipeline that are currently in clinical development. 

Compassionate Use Policy
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