Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
This research study is testing a new medicine called pelacarsen. It's for people who have existing heart and circulation problems, known as ASCVD, and also have high levels of a particular type of fat in their blood called lipoprotein(a), or Lp(a). The study wants to find out if pelacarsen is safe and if it helps to lower Lp(a) levels when patients are already taking another medicine called inclisiran (which helps lower different fats like LDL-C). Participants will either receive pelacarsen or a dummy treatment (placebo) alongside their inclisiran, and the study will compare the results to see if pelacarsen makes a difference.
At a glance
What is this study about?
You might have heard about different types of cholesterol. This study is focused on a specific fatty substance in your blood called lipoprotein(a), often shortened to Lp(a). Some people have naturally high levels of Lp(a), and this can increase their risk of heart and circulation problems. These problems are sometimes called Atherosclerotic Cardiovascular Disease, or ASCVD, and include conditions like heart attacks, strokes, and problems with blood flow to the legs.
The main goal of this study is to test a new medicine called pelacarsen. We want to see if it can safely and effectively lower Lp(a) levels in people who already have ASCVD and high Lp(a). You would already be taking another medicine, inclisiran, which helps lower a different type of 'bad' cholesterol called LDL-C.
By comparing pelacarsen to a dummy treatment (placebo), alongside your usual inclisiran, researchers can understand if pelacarsen helps improve health outcomes and if it has any side effects. This research is important because currently there aren't many specific medicines available to lower Lp(a), and understanding its role could lead to new ways to protect heart health.
Key takeaways
- This study is for people with existing heart/circulation problems and high Lp(a) levels.
- It tests a new medicine, pelacarsen, alongside inclisiran, to lower Lp(a).
- Participation involves regular clinic visits for checks and injections.
- You might receive the new medicine or a dummy treatment (placebo).
- Your health will be closely monitored throughout the study.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you need to be between 18 and 80 years old and have been diagnosed with heart or circulation problems like a past heart attack, stroke, or issues with blood flow in your legs. You also need to be taking stable medication for your cholesterol and any other risk factors like high blood pressure or diabetes.
Crucially, your blood tests must show that you have high levels of a specific fat called Lp(a) (at least 175 nmol/L) and also high levels of another 'bad' cholesterol called LDL-C (above 1.8 mmol/L). Before starting the main part of the study, you would also need to take a dose of inclisiran and be comfortable with it.
There are also some reasons you wouldn't be able to join. For example, if you've recently had a serious heart event, surgery, or major bleeding, or if you have severe kidney or liver problems, uncontrolled high blood pressure, or certain types of heart failure. You also couldn't join if you've already taken inclisiran before or certain other cholesterol-lowering injections in the last few months. If you are pregnant or breastfeeding, you also wouldn't be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 80 years old?
- Have you been diagnosed with heart attack, stroke, or circulation problems in your legs?
- Are you currently taking stable medication for your cholesterol and any high blood pressure/diabetes?
- Are you willing to have blood tests to check your Lp(a) and LDL-C levels?
- Have you NOT had a recent heart attack, stroke, or major surgery/bleeding?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you decide to join, you'll first go through a screening process to make sure the study is right for you. This will involve health checks and blood tests. If you qualify, you'll receive a dose of inclisiran to make sure you tolerate it. After this, you'll be randomly chosen to receive either the new medicine, pelacarsen, or a dummy treatment (placebo). You won't know which one you're getting, and neither will your study doctor. Both treatments are given as injections.
Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to get your study medication. These visits will help monitor your health and how the treatment is working. Your doctors will keep a close eye on any side effects. The study will involve a main treatment period, followed by a period where everyone knows what treatment they are receiving. The total duration of your participation will be explained in detail by the study staff.
Potential risks and benefits
Locations (96)
- Parkway Medical CenterVerified postcodeBirmingham, United States· Recruiting
- Clinical Research Inst of ArizonaVerified postcodeSun City West, United States· Recruiting
- National Heart InstituteVerified postcodeBeverly Hills, United States· Recruiting
- Interv Cardiology Med GrpVerified postcodeWest Hills, United States· Recruiting
- Excel Medical Clinical Trials LLCVerified postcodeBoca Raton, United States· Recruiting
- Jacksonville Center for ClinicalVerified postcodeJacksonville, United States· Recruiting
- K2 Medical Research LLCVerified postcodeMaitland, United States· Recruiting
- University of Miami HospitalVerified postcodeMiami, United States· Recruiting
- Baptist Health SouthVerified postcodeMiami, United States· Recruiting
- Inpatient Research Clinical LLCVerified postcodeMiami Lakes, United States· Recruiting
- Inpatient Research Clinical LLCVerified postcodeMiami Lakes, United States· Recruiting
- FXM Clin Res Miramar LLCVerified postcodeMiramar, United States· Recruiting
Common questions
What is Lp(a)?
Lp(a) is a specific type of fat in your blood, similar to 'bad' cholesterol (LDL-C). High levels can increase your risk of heart problems.
What is ASCVD?
ASCVD stands for Atherosclerotic Cardiovascular Disease. It's a general term for heart and circulation problems like heart attacks, strokes, and narrowed arteries.
Will I know if I'm getting the real medicine?
Neither you nor your study doctor will know if you're receiving pelacarsen or the dummy treatment (placebo) during the main part of the study. This helps make the study fair.
How is the study medicine given?
Both the active medicine (pelacarsen) and the dummy treatment (placebo) are given as injections.
What if I want to leave the study?
You are free to leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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