RecruitingPHASE3INTERVENTIONAL

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

This study, called an "open-label extension," is for people who have already taken part in a previous clinical trial for a medicine called pelacarsen. If you successfully completed that first study, this new study gives you a chance to continue taking pelacarsen. The main goal is to carefully check how safe the medicine is over a longer period and how well people tolerate it. Pelacarsen is being studied for people with existing heart and blood vessel disease and high levels of a specific type of cholesterol called Lipoprotein(a), or Lp(a). You would take an 80 mg dose once a month.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

5,700

Start

11 May 2026

Estimated completion

09 Jan 2030

Cardiovascular Disease and Lipoprotein(a)

What is this study about?

You might be familiar with this study if you've already taken part in a clinical trial for a medicine called pelacarsen. This new study is an extension, meaning it allows people who successfully completed the previous trial to continue receiving pelacarsen. It's called "open-label" because both you and the study team will know you are receiving the active medicine, unlike the previous study where some people might have received a placebo.

The main purpose of this follow-up study is to understand how safe pelacarsen is when taken for a longer time. The researchers will also watch to see how well patients tolerate the medication over many months. Pelacarsen is a medicine being investigated for people who have heart and blood vessel disease and also have high levels of a particular kind of cholesterol known as Lipoprotein(a), or Lp(a).

Doctors are interested in Lp(a) because high levels are linked to a higher risk of heart disease. This study helps gather more information about pelacarsen's long-term effects, which is very important for understanding if it could be a safe and effective treatment option in the future.

Key takeaways

This study is a follow-up for people who've completed a previous pelacarsen trial.
It aims to check the long-term safety of pelacarsen for heart disease and high Lp(a).
Both you and the doctors will know you are receiving the active medicine.
Participation involves taking pelacarsen once a month and regular health checks.
You can stop participating at any time.
It's important to discuss any concerns with the study team.

Who may be eligible?

To be part of this study, you must have successfully completed the previous study involving pelacarsen and have been taking the study medicine right up until the end of that trial.

There are also some reasons why you might not be able to join. For instance, if you stopped taking the study medicine for six months or more during the previous trial, you wouldn't be eligible. Also, if you have any other significant health problems that the study doctor thinks could make it unsafe for you to participate or interfere with the study, you wouldn't be able to join.

You also can't be taking any other new, experimental medicines or treatments, and you must not be allergic to pelacarsen or any of its ingredients.

Quick self-check

Did I successfully complete the previous pelacarsen clinical trial?
Was I taking the study medicine right up until the end of that trial?
Do I have any significant health conditions that might make taking study medicine unsafe?
Am I currently taking any other experimental medicines or treatments?
Do I have any known allergies to pelacarsen or its ingredients?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to take pelacarsen at a dose of 80 mg once a month. This study is generally for people who were on the study medicine at the end of the previous clinical trial. The study team will regularly check in with you to monitor your health and ensure the medicine is safe for you. This will likely involve regular visits to the clinic, blood tests, and discussions about how you are feeling. The exact number of visits and the assessments performed will be explained in detail by the study team, but the overall aim is to gather long-term safety information.

Potential risks and benefits

The potential benefits of joining this study include continued access to pelacarsen, which may help manage your Lp(a) levels and potentially reduce your risk of heart disease. However, as with any medication, there are potential risks and side effects that will be carefully explained to you by the study team. You'll be closely monitored for any reactions or health changes. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (559)

SEC Clinical Research LLC
Andalusia, United States· Recruiting
Heart Center Research Llc
Huntsville, United States· Recruiting
Mobile Heart Specialists
Mobile, United States· Recruiting
Mercy Gilbert Medical Center
Gilbert, United States· Recruiting
Clinical Research Inst of Arizona
Sun City West, United States· Recruiting
Eclipse Clinical Research
Tucson, United States· Recruiting
Cardiovascular Res Found
Beverly Hills, United States· Recruiting
National Heart Institute
Beverly Hills, United States· Recruiting
Valley Clinical Trials Inc
Covina, United States· Recruiting
Keck Medical Center USC
Los Angeles, United States· Recruiting
UCSF
San Francisco, United States· Recruiting
Helping Hands Medical Associates INC
Santa Ana, United States· Recruiting

+547 more sites — see the official record for the full list.

Common questions

What is pelacarsen?

Pelacarsen is an experimental medicine being studied to lower a specific type of cholesterol called Lipoprotein(a) (Lp(a)), which is linked to heart disease.

Why is this study 'open-label'?

Open-label means that both you and the study doctors will know you are receiving the active medicine, pelacarsen, rather than a sugar pill or different treatment.

Who can join this study?

This study is specifically for people who have already completed a previous clinical trial for pelacarsen and were still taking the medicine at the end of that trial.

What does 'long-term safety' mean?

It means the study will monitor your health over an extended period to see if there are any side effects or health issues that only show up after taking the medicine for a long time.

Can I stop taking part if I change my mind?

Yes, you are completely free to leave the study at any point without it affecting your usual medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.