This clinical trial focuses on studying a medication called pelacarsen (also known as TQJ230) in people who have atherosclerotic cardiovascular disease. This is a condition where arteries become hardened and narrowed due to the buildup of fatty deposits on their walls. The study specifically looks at patients who have high levels of a substance called Lp(a) in their blood, which is associated with increased heart disease risk.
The purpose of this research is to evaluate how safe the medication is and how well patients tolerate it when used for a longer period. The medication is given as a subcutaneous injection (under the skin) using a pre-filled syringe. This is an open-label extension study, which means all participants will receive the actual medication, and it continues treatment for patients who completed an earlier study called Lp(a)HORIZON.
During the study, participants will receive regular doses of pelacarsen for up to 36 months. The maximum daily dose is 80 milligrams. The study will monitor participants’ health through regular check-ups and blood tests to ensure their safety while taking the medication. Researchers will track various health measurements and any side effects that may occur during the treatment period.
1Initial visit
You will receive information about the open-label extension trial that evaluates the long-term safety of pelacarsen (TQJ230) medication
The trial is designed for patients who have completed the previous Lp(a)HORIZON study
You will need to provide informed consent before any study procedures begin
2Medication administration
You will receive pelacarsen (TQJ230) as a solution for injection
The medication will be administered through subcutaneous injection (under the skin) using a pre-filled syringe
The treatment will continue throughout the study period until 2029
3Safety monitoring
Regular check-ups will monitor your health status and any potential side effects
Medical staff will track any adverse events (unwanted effects) that may occur during treatment
Laboratory tests will be performed to monitor your health indicators
Your vital signs will be regularly checked
4Health measurements
Your Lp(a) levels (a type of cholesterol) will be measured throughout the study
The medical team will monitor your cardiovascular health
Changes in your health status will be compared to your initial condition from both the previous study and this extension trial
5Study completion
The study is expected to continue until March 31, 2029
Final health assessments will be conducted to evaluate the overall effects of the treatment
Who Can Join the Study?
Must be aged between 18 and 85 years old
Must provide informed consent (written agreement to participate) before any study procedures begin
Must have completed the previous Lp(a)HORIZON study while still taking the study medication
Must have established cardiovascular disease (conditions affecting the heart and blood vessels)
Must have elevated levels of Lp(a) (a type of protein in the blood that can increase risk of heart disease)
Can be either male or female
Who Cannot Join the Study?
History of severe allergic reactions or anaphylaxis to any oligonucleotide (type of medication) or components of pelacarsen
Presence of active, chronic, or recurring inflammatory conditions (diseases causing inflammation in the body)
Significant kidney problems with estimated glomerular filtration rate (kidney function test) below 30 mL/min/1.73m²
Uncontrolled high blood pressure (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
History of major bleeding within the past 12 months
Active liver disease or significant liver function abnormalities
Currently pregnant or breastfeeding women
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to comply with study procedures or follow-up visits
Participation in another clinical trial within 30 days before this study
Current drug or alcohol abuse that could interfere with study participation
Life expectancy less than the duration of the study due to other medical conditions
Pelacarsen (TQJ230) is a medication being studied for people with elevated levels of Lp(a) and established cardiovascular disease. This medication is designed to help reduce Lp(a) levels in the blood. Lp(a) is a type of lipoprotein that can increase the risk of heart disease when present in high amounts. The medication is being evaluated for its long-term safety and how well patients can tolerate it over an extended period.
Atherosclerotic Cardiovascular Disease (ASCVD) – A condition where fatty deposits (plaque) build up inside the arteries, causing them to narrow and harden over time. The plaque consists mainly of fat, cholesterol, and other substances that accumulate on the inner walls of blood vessels. This progressive disease develops slowly over many years, often starting in early adulthood. As arteries become narrower, blood flow to various parts of the body becomes restricted. The condition can affect arteries throughout the body, particularly those supplying blood to the heart, brain, and limbs.
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