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Antisense Oligonucleotide

Olpasiran for Cardiovascular Disease

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Age 18 to ≤ 85 years
Must not have
Severe heart failure
Severe renal dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

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).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects for Olpasiran aren't detailed here, similar medications may cause injection site reactions, liver enzyme changes, flu-like symptoms and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a heart attack or surgery to open my heart's arteries and have at least one other heart risk factor.
Select...
I am between 18 and 85 years old.
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I have had a heart attack or stent placement and have at least one other risk factor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe heart failure.
Select...
I have severe kidney problems.
Select...
I have had a bleeding stroke in the past.
Select...
I am undergoing or planning to undergo a procedure to remove bad cholesterol.
Select...
I have been treated with RNA therapy for Lp(a).
Select...
I am scheduled for heart surgery or artery repair.
Select...
I have a history of significant bleeding problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04270760
19%
COVID-19
7%
Urinary tract infection
4%
Upper respiratory tract infection
4%
Anaemia
4%
Contusion
2%
Cellulitis
2%
Fatigue
2%
Arthralgia
2%
Pain in extremity
2%
Cough
2%
Oedema peripheral
2%
Nasopharyngitis
2%
Fall
2%
Hypertension
2%
Abdominal pain
2%
Headache
2%
Femur fracture
2%
Sinusitis
2%
Type 2 diabetes mellitus
2%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 5; Treatment Period: Placebo Q12W
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
Group 4; Treatment Period: Olpasiran 225 mg Q24W
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
Group 1; Treatment Period: Olpasiran 10 mg Q12W
Group 2; Treatment Period: Olpasiran 75 mg Q12W
Group 3; Treatment Period: Olpasiran 225 mg Q12W
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
Group 5; Extended Safety Follow-up: Placebo Q12W

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~370

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,466 Previous Clinical Trials
1,394,199 Total Patients Enrolled
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
937,943 Total Patients Enrolled

Media Library

Olpasiran (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05581303 — Phase 3
Cardiovascular Disease Research Study Groups: Placebo, Olpasiran
Cardiovascular Disease Clinical Trial 2023: Olpasiran Highlights & Side Effects. Trial Name: NCT05581303 — Phase 3
Olpasiran (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581303 — Phase 3
~3648 spots leftby Dec 2026
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