In short
Olpasiran is an investigational substance being studied to lower elevated lipoprotein(a), a risk factor for cardiovascular disease. It is not yet authorised as a medicine. Two Phase 3 trials are currently authorised: one with 6,330 participants testing cardiovascular outcomes, and one with 398 participants measuring plaque changes in the heart's arteries.
Olpasiran is a nucleic acid-based substance developed by Amgen Inc. It is classified in the cardiovascular disease therapeutic area and is an investigational substance with no marketing authorisation in the product records. The substance is also known by its development code AMG 890.
Key points
- Olpasiran is an investigational nucleic acid-based substance given by subcutaneous injection.
- It is being tested in two Phase 3 trials for cardiovascular disease in people with elevated lipoprotein(a).
- The larger trial, OCEAN(a)-Outcomes, has 6,330 participants and measures time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization.
- The smaller trial, OCEAN(a)-CCTA, has 398 participants and measures change in non-calcified plaque volume at week 72.
- Both trials are currently authorised but not yet completed.
- Olpasiran is developed by Amgen Inc. and has no marketing authorisation.
What is olpasiran?
Olpasiran is an investigational nucleic acid-based substance being studied for cardiovascular disease. It is not yet authorised as a medicine. The product records from the EU Clinical Trials Information System list it as a solution for injection in a pre-filled syringe for subcutaneous use. Olpasiran is supplied by Amgen Inc. and appears in the registry under the name olpasiran. In the trials, the substance is also referred to by the development code AMG 890.
How does olpasiran work?
Olpasiran is designed to lower elevated lipoprotein(a), often shortened to Lp(a). Lipoprotein(a) is a protein that transports cholesterol, a fatty substance, in the blood. Lp(a) has been described as “LDL with Velcro” because it is wrapped in a sticky protein that can easily block artery walls. Lp(a) also interferes with blood clotting. Both of these factors increase the risk of heart disease and stroke, and the higher a person's Lp(a) levels, the greater the risk. Elevated plasma Lp(a) has been identified as a strong risk factor for the development and progression of atherosclerotic cardiovascular disease. The aim of the research is to see if olpasiran reduces cardiovascular events and lowers Lp(a).
Which conditions is it studied for?
Olpasiran is being studied for cardiovascular disease, specifically in people with atherosclerotic cardiovascular disease (ASCVD) and elevated lipoprotein(a). The trials cover the following conditions:
- Cardiovascular disease — a general term for conditions affecting the heart and blood vessels. The OCEAN(a)-CCTA trial includes participants with cardiovascular disease.
- Atherosclerotic cardiovascular disease (ASCVD) and elevated lipoprotein(a) — a condition where fatty deposits build up in artery walls and Lp(a) levels are higher than normal. The OCEAN(a)-Outcomes trial focuses on this population.
How is olpasiran given?
Olpasiran is given as a solution for injection in a pre-filled syringe. The route of administration is subcutaneous use, meaning it is injected under the skin. In the trial records, the dose is listed as 00 mg, which means the specific dose was not reported in the register.
What do the clinical trials show?
Two Phase 3 trials of olpasiran are currently authorised. Both are interventional studies that compare olpasiran with a placebo. The trials are part of the OCEAN(a) programme, which stands for olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction.
What are the trials measuring?
The OCEAN(a)-Outcomes trial measures the time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization, whichever occurs first. The OCEAN(a)-CCTA trial measures the change in non-calcified plaque volume from baseline to week 72, assessed by coronary computed tomography angiography (CCTA). Non-calcified plaque is a type of fatty deposit in the arteries that can be seen on a special heart scan.
Who can take part in these trials?
The OCEAN(a)-Outcomes trial includes 6,330 participants with atherosclerotic cardiovascular disease and elevated Lp(a). The OCEAN(a)-CCTA trial includes 398 participants with cardiovascular disease. Both trials are authorised but not yet completed.
What side effects are known?
The supplementary source provided does not report side effects of olpasiran. The trial records do not include adverse event data. Therefore, no side effect information is available from the provided sources.