Not recruiting

Study of pelacarsen and inclisiran in patients with atherosclerotic cardiovascular disease who have high levels of LDL cholesterol and lipoprotein(a)

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with atherosclerotic cardiovascular disease, a condition where arteries become narrowed due to buildup of fatty deposits. The study will test two medications: pelacarsen (also known as TQJ230) and inclisiran. These medications are designed to help lower harmful types of cholesterol and fat-like substances in the blood, specifically LDL-cholesterol and a substance called Lp(a).

The purpose of this research is to determine if pelacarsen, when used together with inclisiran, can effectively reduce levels of Lp(a) in the blood. During the study, participants will receive either pelacarsen or placebo as an injection under the skin, while all participants will receive inclisiran. Both medications will be given through pre-filled syringes with safety devices.

The study will last for approximately 12 months. Throughout this time, participants will need to continue taking their regular heart medications. Doctors will monitor participants' health through regular check-ups and blood tests to ensure safety and measure how well the treatment is working.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
You will undergo initial screening to confirm eligibility for the study. The screening includes blood tests to check your Lp(a) levels (must be ≥175 nmol/L) and LDL-C levels (must be >70 mg/dL).
Your medical history will be reviewed to confirm you have atherosclerotic cardiovascular disease (ASCVD), which includes heart disease, cerebrovascular disease, or peripheral arterial disease.
Step 2
Run-in period with inclisiran
You will receive background treatment with inclisiran, a medication given by injection under the skin.
You must complete this initial treatment period successfully to continue in the study.
Step 3
Randomization and baseline visit
You will be randomly assigned to receive either pelacarsen (TQJ230) or a placebo (inactive substance).
Both medications will be given as injections under the skin.
You will continue receiving inclisiran throughout the study.
Step 4
Treatment period
The study will continue for several months, with a key assessment at month 6.
Regular check-ups will include:
Blood tests to monitor Lp(a) levels
Safety monitoring through blood tests, heart tracings (ECGs), and vital signs
Assessment of any side effects or health changes
Step 5
Six-month evaluation
At month 6, your Lp(a) levels will be measured to evaluate the effectiveness of the treatment.
The goal is to determine if the treatment helps reduce Lp(a) levels below 125 nmol/L.
Step 6
Ongoing monitoring
Throughout the study, you will be monitored for any side effects or safety concerns.
Regular assessments will include blood tests, heart tracings, and vital sign measurements.
The study is expected to continue until September 2028.

Who can join the trial?

7 criteria

Age between 18 and 80 years old at the time of screening
Must have confirmed atherosclerotic cardiovascular disease, which includes at least one of these conditions: - Coronary heart disease (problems with blood vessels supplying the heart) - Cerebrovascular disease (problems with blood vessels supplying the brain) - Peripheral arterial disease (problems with blood circulation in the legs)
Must be taking stable doses of cholesterol-lowering medications for at least 30 days before screening
Must complete a trial period of treatment with inclisiran (a cholesterol-lowering medication)
Must be on standard treatments for other heart-related conditions like high blood pressure or diabetes for at least 30 days before starting the study
Must have Lipoprotein(a) levels of 175 nmol/L or higher in blood tests at screening (Lipoprotein(a) is a type of cholesterol-carrying particle in the blood)
Must have LDL cholesterol levels above 70 mg/dL (or above 1.8 mmol/L) in blood tests at screening (LDL is often called "bad" cholesterol)

Who cannot join the trial?

15 criteria

Age below 18 years or above 80 years
Known allergies or hypersensitivity to the study medication (pelacarsen or inclisiran) or any of their components
History of severe allergic reactions to any medications
Pregnant or breastfeeding women
Active liver disease or significant liver function abnormalities
Severe kidney disease (poor kidney function)
Uncontrolled high blood pressure (readings consistently above 160/100 mmHg)
Recent heart attack or stroke (within past 3 months)
Major surgery within the past 3 months
Currently participating in another clinical trial
Any condition that, in the opinion of the study doctor, would make it unsafe to participate
Unable to provide informed consent
History of bleeding disorders or current use of blood-thinning medications
Active cancer or cancer treatment within the past 5 years
Unstable heart conditions requiring frequent medication adjustments

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Verified sites

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Azienda USL Toscana Sud Est
Arezzo, Italy
Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France

Trial locations

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Investigated drugs

Pelacarsen
(also known as TQJ230) is a medication being studied to reduce high levels of lipoprotein(a), also known as Lp(a), in the blood. This type of protein is associated with increased risk of heart and blood vessel diseases. The medication is designed to specifically target and lower Lp(a) levels in patients who have existing cardiovascular disease.
Inclisiran
is a medication used to lower LDL cholesterol (often called "bad" cholesterol) in the blood. In this study, it is used as a background treatment for all participants who have high LDL cholesterol levels. It works by helping the liver remove more LDL cholesterol from the bloodstream.

What is already known about the treatment

Pelacarsen
An investigational antisense oligonucleotide medication administered through subcutaneous injection, designed to reduce lipoprotein(a) levels in patients with atherosclerotic cardiovascular disease. The drug works by targeting and inhibiting the production of apolipoprotein(a) in the liver, thereby reducing the levels of lipoprotein(a) in the bloodstream. Currently being studied in clinical trials, this medication represents a novel approach in cardiovascular medicine for patients with elevated lipoprotein(a) levels who remain at risk despite conventional lipid-lowering therapies.
Inclisiran
A small interfering RNA medication administered via subcutaneous injection that targets PCSK9 protein production in the liver to reduce LDL cholesterol levels. This approved medication works through a unique mechanism of RNA interference, effectively lowering LDL cholesterol levels for extended periods with just twice-yearly dosing after initial administration. It belongs to the class of PCSK9 inhibitors and is used in patients with atherosclerotic cardiovascular disease who need additional LDL cholesterol reduction beyond traditional statin therapy.

Investigated diseases

Atherosclerotic Cardiovascular Disease (ASCVD) - A condition where fatty deposits (plaques) build up inside the arteries, causing them to narrow and harden over time. The process begins when cholesterol and other substances accumulate in the arterial walls, leading to inflammation and gradual thickening of these vessels. As the disease progresses, blood flow becomes restricted in various parts of the body, particularly in the heart and brain. The plaque buildup occurs gradually over many years and can affect multiple arteries throughout the body. This disease can develop due to various factors, including high blood pressure, high cholesterol levels, and lifestyle factors. ASCVD typically develops silently over decades before becoming noticeable.