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One Dose: Could it help conquer high cholesterol?

You may be able to take part in the Heart-2 study.
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The Heart-2 study will help determine if a single dose of an investigational medicine, called VERVE-102, can safely and permanently reduce low-density lipoprotein cholesterol (LDL-C) or “bad” cholesterol in people with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD).
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About the Heart-2 study

The Heart-2 study is a clinical trial for people with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD) and high levels of low-density lipoprotein cholesterol (LDL-C). The purpose of the Heart-2 study is to assess the safety and tolerability of VERVE-102 and see if it can help lower LDL-C levels with a single dose.
 
VERVE-102 is designed to permanently turn off the production of the PCSK9 protein in the liver by inactivating the PCSK9 gene using an approach called gene editing. This may reduce LDL-C levels in the bloodstream. Because gene editing is expected to be a permanent change, it is given just once through an intravenous (IV) infusion which means it will be administered into a vein.

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About the investigational medicine

The investigational medicine VERVE-102 targets a gene that is known to cause high levels of low-density lipoprotein cholesterol (LDL-C) in the blood. High LDL-C levels contribute to serious cardiovascular (CV) events, such as heart attacks and strokes. The Heart-2 study could help find a potential breakthrough in treating high LDL-C.

Heterozygous familial hypercholesterolemia (HeFH) and
premature coronary artery disease (CAD)

While high low-density lipoprotein cholesterol (LDL-C) levels are harmful to everyone, they are particularly serious and more challenging to manage for certain groups of people. Below are two such instances:
HeFH
HeFH is a condition that results in lifelong high LDL-C levels because of a person’s genetics. This means they have inherited the condition. There is often a family history of high LDL-C or cardiovascular (CV) events such as heart attacks or strokes early in life.
Premature CAD
Coronary artery disease, or CAD, results from the fatty deposits forming in the arteries that supply blood and nutrients to the heart, called coronary arteries. CAD usually develops later in life. It is considered premature CAD in people who have developed serious heart disease due to high cholesterol before the age of 65 in women or before the age of 55 in men. Managing CAD typically involves lifelong efforts to lower LDL-C.

What to expect when participating in the Heart-2 study

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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
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You will be reimbursed for your time during participation
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You will be reimbursed for travel and other expenses during participation
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The clinical trial medication and clinical trial-related tests will be provided at no cost to participants
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A team of doctors and nurses will monitor your health carefully during the clinical trial
The clinical trial has been cleared by an Institutional Review Board/Ethics Committee and national health authority, which protects the participants’ rights, safety, and well-being
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Participant qualifications

You may be able to take part if you*:
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Are 18-70 years old
(female participants cannot be pregnant or capable of
becoming pregnant)
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Have a diagnosis of HeFH and/or premature CAD
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Have high LDL-C levels even though you are being treated with statins or cholesterol-lowering medicines
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Are not taking a PCSK9 inhibitor such as Praluent® (alirocumab), Repatha® (evolocumab), or Leqvio® (inclisiran).
*Additional eligibility criteria apply
See if you prequalify
See if you prequalify

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 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.
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Study periods

1

Screening period

(up to 3 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 four days)
If you qualify and decide to participate, the study treatment period will involve a stay of approximately four days/three nights at the study site, during which:
  • You will receive a single dose of VERVE-102 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-102. If needed, your stay may be extended for additional monitoring.
3

Follow-up period

(about one year)
  • There will be up to 10 follow-up visits over the year after receiving VERVE-102 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

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