Hyperlipidemia Patient Engagement Study
Research type
Research Study
Full 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
IRAS ID
352124
Contact name
Thomas Ashdown
Contact email
Sponsor organisation
Verve Therapeutics Inc.
Duration of Study in the UK
2 years, 9 months, 5 days
Research summary
This patient engagement study is being carried out to provide participants with or at high risk for atherosclerotic cardiovascular disease (ASCVD) with uncontrolled hyperlipidaemia the opportunity to become familiar with the clinical trials environment and clinical team before considering if they want to take part in a future gene editing clinical trial for their condition. The study will also allow participants to undergo a series of assessments to establish a clinical baseline.
This study will take approximately two weeks for the participants to complete, but optional visits can take place for up to 12 months. The participants will attend an in-person visit to the study site on Day 1, during which they will be asked to provide their informed consent. Following the informed consent, they will receive a tour of the site and undergo a series of basic clinical assessments (such as vital signs, ECGs, blood samples and a liver FibroScan) to establish a clinical baseline. Participants may be provided with a hard copy of a Participant Information Sheet/Informed Consent Form (PIS/ICF) (provided this document has received approval from a REC) for upcoming relevant gene editing clinical trials. This will allow potential participants to take the information home for a thorough review and discussion with friends and family before potentially attending a screening appointment for a gene editing clinical trial.
A follow-up telephone call with the Study Doctor will be conducted within two weeks after the participant has completed the patient engagement visit assessments to discuss the results of the clinical assessments and allow participants to ask any questions. If there are any significant changes in their health or medications, participants may be offered the opportunity for optional additional follow-up visits for repeat study procedures within 12 months of signing the PIS/ICF.
REC name
London - South East Research Ethics Committee
REC reference
24/PR/1623
Date of REC Opinion
20 Jan 2025
REC opinion
Further Information Favourable Opinion