AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase 1b Study of VERVE-201 in Patients with Refractory Hyperlipidemia

This study, called VERVE-201, is exploring a new treatment for people who have very high levels of cholesterol (a fatty substance in your blood) that hasn't gotten better with current medications. This condition is sometimes called 'refractory hyperlipidemia'. This is a very early stage of research, meaning it's the first time this specific treatment is being given to people. The main goals are to check if the new treatment is safe, to see what side effects it might have, and to understand how it affects the body. It's for adults aged 18 and older, both men and women. This is a crucial step to see if this new approach could help people in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Verve Therapeutics Inc.

Enrolment target

Start

30 Mar 2026

Refractory hyperlipidemia

What is this study about?

You might have heard about cholesterol – it's a fatty substance in your blood that, in high amounts, can lead to serious health problems like heart disease. Usually, doctors prescribe medicines, and changes to your diet and lifestyle, to help lower cholesterol.

However, for some people, even with the best efforts and treatments, their cholesterol levels remain dangerously high. Doctors call this 'refractory hyperlipidemia' because it's hard to treat or 'refractory' to standard therapies. These individuals are at a higher risk of health issues, and there's a real need for new and effective ways to help them.

This particular study is a very early step in developing a new treatment, code-named VERVE-201. Because it's the first time this treatment is being used in people, the main aim is to make sure it's safe to use. Researchers are also trying to understand how our bodies react to it and what effects it has. This information is vital before it can be tested in more people.

Key takeaways

This study is for adults with very high cholesterol not helped by other medicines.
It's a very early study to check the safety of a new treatment, VERVE-201.
Participation involves medical checks and close monitoring.
Potential risks and benefits will be fully explained.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and older. Both men and women are welcome to take part.

To be considered for this study, you must have very high cholesterol levels that haven't responded well to other treatments you've tried. This means your doctor has probably tried different medicines, and your cholesterol is still higher than it should be.

There will be other health checks and requirements to make sure the study is right for you, and that you can safely take part. These will be explained in full by the study team.

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.

Am I 18 years old or older?
Have I been told my cholesterol is very high, even after trying other treatments?
Am I comfortable with regular clinic visits and health checks?
Do I understand that this is an early-stage study for a new treatment?

Answer every question to see your result.

What does participation involve?

Taking part in a study like this usually involves several visits to a clinic or hospital for check-ups and assessments. You'll likely have blood tests, physical examinations, and other tests to monitor your health and how your body is reacting to the study treatment. The study medication will be given under close medical supervision. You will be closely followed for a period of time after receiving the treatment to check for any effects. The total duration of your participation, including all visits and follow-ups, will be fully explained by the study team before you decide to join.

Potential risks and benefits

Participating in research studies can offer the potential benefit of accessing new treatments that aren't yet widely available, and you'll be closely monitored by a medical team. However, because this is an early study, the potential benefits are not fully known, and there might be side effects from the new medication that are also not yet fully understood. All possible risks will be carefully explained to you. Remember, joining a study is always your choice, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What does 'refractory hyperlipidemia' mean?

It means you have very high levels of cholesterol (a fatty substance in your blood) that haven't been successfully lowered by standard treatments or medicines.

What is a 'Phase 1b' study?

This is an early stage of testing a new treatment in people for the first time. The main goals are to check if it's safe and to see how it works in the body.

Will this study cure my high cholesterol?

It's too early to say. This study is mainly focused on safety and understanding how the treatment works, not yet on how effective it is at treating your condition. We hope to learn if it could be a helpful option in the future.

Do I have to stop my current cholesterol medication?

This will depend on the study's specific rules. The research team will discuss all your current medications with you and explain what changes, if any, are needed.

What if I change my mind after joining?

You have the right to leave the study at any time, for any reason, without it affecting your medical care.