Verve Therapeutics: Observational study

Full Study Title: Engaging Adult Participants with Hyperlipidemia Considering Participation in Gene Editing Clinical Trials: A Study to Provide Familiarity with Trial Environments and Establish Baseline Clinical Data.

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 hyperlipidemia decide if they want to participate in and confirm if they are suitable for ongoing gene editing studies aimed to help lower lipids/cholesterol.

Who can take part?

We will check your eligibility for the patient engagement study using the following criteria:

1. You must be a male or female aged between 18 to 70 years (inclusive).
2. You must have a known or suspected history of one of the following:
3. ASCVD and/or,
4. Severe hypercholesterolemia (high levels of cholesterol in blood) and/or,
5. Familial hypercholesterolemia (FH) (an inherited condition that causes very high cholesterol levels) and/or,
6. Severe hypertriglyceridemia (very high levels of triglycerides, a type of fat, in the blood) and/or,
7. Prior or documented history of elevated Lipoprotein(a) (high levels of a specific type of cholesterol particle in the blood that increases risk for heart disease)
8. You must be currently taking a cholesterol-lowering medicine (e.g., statin, ezetimibe, or PCSK9 inhibitor) or have a documented history of side effects to at least one cholesterol-lowering medicine.
9. You must have cholesterol levels that remain too high even after taking approved cholesterol lowering medications. You must be able and willing to provide informed consent to participate.
10. You must be able and willing to comply with study assessments.

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).

The whole process takes approximately 2 weeks, but optional visits can take place for up to 12 months

Study participants will be reimbursed for any study-related travel expenses. For your efforts you will receive up to a maximum amount of £40 per visit. Taking part in completely voluntary and you must be registered any of our practices. If you think you’re eligible and interested in taking part, please email hcl.trials@nhs.net