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

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What is this study about?

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.

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.

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.

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.

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

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier De Beziers	Beziers	France
Hospital Universitario De Navarra	Pamplona	Spain
ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim	Mannheim	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Gesundheitsverbund Landkreis Konstanz gGmbH	Singen (Hohentwiel)	Germany
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Hospital Santa Maria Della Misericordia	Perugia	Italy
Klinische Forschung Hannover-Mitte GmbH	Hanover	Germany
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH	Dresden	Germany
Ospedale Mater Salutis Di Legnago	Legnago	Italy
Medisch Spectrum Twente	Enschede	The Netherlands
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Klinikum Bielefeld gGmbH	Bielefeld	Germany
Hospital Quironsalud Barcelona	Barcelona	Spain
Azienda USL Toscana Sud Est	Arezzo	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hopital Saint Joseph	Marseille	France
Centre Hospitalier De Cholet	Cholet	France
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta	Caserta	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Instituto Medico Quirurgico San Rafael S.A.	A Coruna Galicia	Spain
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
MVZ Diabeteszentrum Dr. Tews GmbH	Gelnhausen	Germany
Mtf at Kzmxenfzy Gcol armmhacmkk Haadobhczty	Chemnitz	Germany
Snzbd Mvuws Dwwpz Aarveg Hucdzlio	Pordenone	Italy
Ddzfycxdzu Phnspvi	Potsdam	Germany
Adwrxroug Urg	Amsterdam	The Netherlands
Ssowybqhvmiumfcazr dgi kxyqntebvunomyj Pkldwfzuxqxdwfvtwz Gffx	Berlin	Germany
Hcftjyaa Ivsczhl Edmjx	Huelva	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	16.03.2026
Germany	Recruiting	16.03.2026
Italy	Recruiting	16.03.2026
Spain	Recruiting	16.03.2026
The Netherlands	Recruiting	16.03.2026

Trial locations

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.

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.

Trial ID:

2024-516356-18-00

Protocol code:

CTQJ230A12304

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?