Summary

• We are conducting a patient engagement study, which is a research study that does not include an investigational drug.
• This study aims to help participants with or at high risk for ASCVD and/or uncontrolled hyperlipidaemia decide if they want to participate in and confirm if suitable for future gene editing studies aimed to help lower lipids/cholesterol.
• In this study we are recruiting participants aged 18 to 70 who have or are at high risk to develop atherosclerotic cardiovascular disease (ASCVD) and/or uncontrolled hyperlipidaemia (high levels of bad cholesterol despite taking available treatments). ASCVD is caused by the buildup of fat in the arteries limiting blood flow to organs which leads to heart attack and stroke.
• We will give you a tour of the study unit and conduct a number of clinical tests and assessments to establish your current health status.
• You will be reimbursed for your travel expenses if you take part in this study.

A member of our recruitment team will discuss the patient engagement study with you before your in-person visit to explain the study details and confirm interest.

If you are interested in participating in this patient engagement study:

• You will be asked to attend an in-person visit, during which we will give you a tour of the study unit and perform tests and assessments such as taking your blood, checking your heart and carrying out a physical examination. These tests can be spread over multiple days (if required).
• You will have a follow-up telephone call with the Study Doctor within 2 weeks after the in-person visit to discuss the results of the clinical assessments you have undergone and provide you with the opportunity to ask any questions.
• While taking part in the study, you will receive information on available gene editing clinical trials that may be a good fit for you. If you agree, we will also provide you with a hard copy of a patient information sheet for an upcoming gene editing clinical trial to take home (if available).
• This means the whole process takes approximately 2 weeks, but optional visits can take place for up to 12 months.
• You may be offered an optional additional in-person visit for repeat clinical tests and assessments if there are significant changes to your health, at the Study Doctor’s discretion. In total, you will come to the research unit at least once.