Olpasiran for Cardiovascular Disease

Recruiting at 840 trial locations

Overseen By Amgen 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

7297 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Olpasiran for cardiovascular disease?

Research on similar drugs, like olmesartan, shows they can help reduce blood pressure and slow the progression of atherosclerosis (buildup of fats in arteries), which may improve heart health. These findings suggest that Olpasiran, if it works similarly, could be effective for cardiovascular disease. ^{1 2 3 4 5}

How does the drug Olpasiran differ from other treatments for cardiovascular disease?

Olpasiran is unique because it targets the angiotensin II type 1 receptor, which is involved in the development of atherosclerosis (buildup of fats and cholesterol in and on artery walls) and hypertension (high blood pressure). This drug not only lowers blood pressure but also reduces oxidative stress and inflammation, potentially reversing the harmful effects of angiotensin II on the cardiovascular system. ^{1 6 7 8 9}

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).

Research Team

MD

Principal Investigator

Amgen

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

Exclusion Criteria

I have severe heart failure.

I have severe kidney problems.

I have had a bleeding stroke in the past.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Olpasiran Experimental Treatment 1 Intervention

Olpasiran will be administered by subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

Placebo will be administered by subcutaneous injection

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

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

Findings from Research

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Angiotensin receptor blockers - advantages of the new sartans. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Prevention of major cardiovascular events with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker early or late after stroke. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Are there meaningful differences in blood pressure control with current antihypertensive agents? [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Four-year clinical outcomes of the OLIVUS-Ex (impact of Olmesartan on progression of coronary atherosclerosis: evaluation by intravascular ultrasound) extension trial. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy in angiotensin receptor blockade: a comparative review of data with olmesartan. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Reduction of Cardiovascular Risk through Angiotensin II Type 1 Receptor Antagonism : Focus on Olmesartan Medoxomil. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Olmesartan for the treatment of arterial hypertension. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Olmesartan prevents cardiac rupture in mice with myocardial infarction by modulating growth differentiation factor 15 and p53. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of sacubitril/valsartan compared with olmesartan in Asian patients with essential hypertension: A randomized, double-blind, 8-week study. [2022]