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Help shape the future of high cholesterol treatment

Be part of the Pulse-1 study

The Pulse-1 study will help determine if a single dose of an investigational medicine, called VERVE-201, can safely reduce low-density lipoprotein cholesterol (LDL-C), often referred to as ‘bad’ cholesterol, in people whose LDL-C remains too high even after taking currently available medicines.

If you have LDL-C levels that remain too high, you may be eligible to take part in the Pulse-1 study.

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About the Pulse-1 study

The Pulse-1 study is a Phase 1b clinical trial enrolling people who are at high risk of serious cardiovascular events, such as heart attack or stroke, due to high cholesterol levels. The Pulse-1 study will help determine if a single dose of an investigational medicine, called VERVE-201, can safely reduce low-density lipoprotein cholesterol (LDL-C) in people whose LDL-C remains high even after taking currently available medicines.

Having high LDL-C levels increases the risk of serious cardiovascular events, such as heart attack or stroke. Lowering LDL-C levels is one of the best ways to reduce these risks.

Up to 36 people in several countries will take part in the Pulse-1 study. Participants will be involved in the trial for up to one year after receiving VERVE-201. After the study is over, participants are expected to join a long-term follow-up study to help researchers understand the safety of VERVE-201 over a longer period.

About the investigational medicine

VERVE-201, the investigational gene editing medicine, is given one time as an intravenous (IV) infusion into a vein in the arm. VERVE-201 is designed to permanently turn off a gene called ANGPTL3 in the liver. Other medicines that block ANGPTL3 activity have been shown to be safe and effective for lowering LDL-C. The gene editing technology being studied has the potential to lower LDL-C levels for many years after a single dose.

The clinical trial has been cleared by an Institutional Review Board/Ethics Committee and national health authority, which protects the participant’s rights, safety, and well-being.

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High LDL-C and atherosclerotic cardiovascular disease (ASCVD)

High LDL-C circulating in the blood is a major cause of atherosclerotic cardiovascular disease (ASCVD). ASCVD is a general term for conditions caused by cholesterol plaque buildup in the arteries. If the plaque buildup becomes severe, it can restrict blood flow and lead to serious events such as a heart attack or stroke. Very high LDL-C levels, defined as levels above 190 mg/dl or 4.9 mmol/L, is considered severe hypercholesterolemia.

One of the most effective ways to reduce the risk of events like heart attack and stroke is to lower the level of LDL-C in the blood below medically recommended goals. Some people have LDL-C that remains higher than their goal even after making lifestyle changes and taking currently available cholesterol-lowering medicines. These individuals are at higher risk compared with patients who do achieve these goals.

High LDL-C and atherosclerotic cardiovascular disease (ASCVD)

High LDL-C circulating in the blood is a major cause of atherosclerotic cardiovascular disease (ASCVD). ASCVD is a general term for conditions caused by cholesterol plaque buildup in the arteries. If the plaque buildup becomes severe, it can restrict blood flow and lead to serious events such as a heart attack or stroke. Very high LDL-C levels, defined as levels above 190 mg/dl or 4.9 mmol/L, is considered severe hypercholesterolemia.

One of the most effective ways to reduce the risk of events like heart attack and stroke is to lower the level of LDL-C in the blood below medically recommended goals. Some people have LDL-C that remains higher than their goal even after making lifestyle changes and taking currently available cholesterol-lowering medicines. These individuals are at higher risk compared with patients who do achieve these goals.

Why might you participate

Participants in the Pulse-1 study will have the opportunity to contribute to the development of a potential new medicine that may help them and other people with high LDL-C, perhaps including family members, in the future. Study participants will receive VERVE-201, which may permanently reduce LDL-C levels. However, it is important to note that the safety and effectiveness of VERVE-201 is still being studied.

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What to expect when participating in the Pulse-1 study

The clinical trial team will explain the possible benefits and risks of participating

If you choose to participate in a clinical trial, you can stop participating at any time

You will be reimbursed for your time during participation

You will be reimbursed for travel or other expenses during participation

VERVE-201 and clinical trial-related tests will be provided at no cost to participants

A team of study doctors and nurses will monitor your health carefully during participation

The study has been cleared by an Institutional Review Board/Ethics Committee and national health authority, which protects participants’ rights, safety, and well-being

Participant qualifications

You may be able to take part if you*:

Are 18-70 years old

Have a medical history of either:

Very high cholesterol levels, known as
severe hypercholesterolemia

OR

ASCVD (e.g., heart attack, stroke, or a stenting or bypass procedure to open a blocked blood vessel)

Have LDL-C levels that remain too high even after taking available LDL-C lowering medicines

(such as statins and/or PCSK9 inhibitors)

In some cases, people cannot take these medicines due to side effects, or they do not have access to these medicines. If this is the case, you may still be able to take part.

*Additional eligibility criteria apply

See if you prequalify

Answer a few questions to see if you prequalify for a clinical trial.

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Your information is stored in a HIPAA-compliant database and provided to the trial sites for follow-up as appropriate. For further information, please see our privacy policy page.

See if you prequalify

Answer a few questions to see if you prequalify for a clinical trial.

GET STARTED

Your information is stored in a HIPPA-compliant database and provided to the trial sites for follow-up as appropriate. For further information, please see our privacy policy page.

Study periods

1

Screening period

(up to three months)

You will attend screening appointments to determine your eligibility for the trial. During these appointments, several tests will be performed, including blood samples and physical examinations.

You will visit the study site twice or more to determine whether the study is right for you. If you are eligible, you will have the option to join the study.
The screening visits need to occur within three months.

2

Study treatment period

(about two days)

If you qualify and decide to participate, the study treatment period will involve a stay of approximately 2 days/1 night at the study site, during which:

You will receive a single dose of VERVE-201 as an IV infusion in your arm.
During your stay at the study site, the study team will monitor your health and conduct assessments similar to the screening period to check how well you tolerate VERVE-201. If needed, your stay may be extended for additional monitoring.

3

Follow-up period

(about one year)

There will be up to 11 follow-up visits over the year after receiving VERVE-201 to continue to monitor your health, including the end-of-study visit.
After the end-of-study visit, you will continue participating in a long-term follow-up study to monitor your safety and cholesterol levels. Many of these visits can be done from home.

Study site locations

See if you prequalify