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Clinical trial summary
We are conducting a clinical trial, called the Heart-2 study. The Heart-2 study is evaluating the safety and tolerability of a study drug in addition to seeing if it may lower cholesterol in people with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD). People with premature CAD experience cholesterol driven blockage of coronary arteries early in life and are at high risk of further complications. Study participants will be reimbursed for their time commitment to this study.
- The study drug is designed to turn off a gene in the liver to potentially lower the amount of 'bad' cholesterol in the body.
- The study drug is given one time through an intravenous infusion (this means that the drug will be administered into a vein.
- The Heart-2 study is assessing if the study drug can safely and permanently reduce ‘bad’ cholesterol after a single dose.
- This clinical trial will involve you staying at our clinical facility based in London Bridge for up to 4 nights (see below).
If you are interested in participating in this trial:-
- To be considered for the trial, you will first need to attend a screening appointment so we can check if you are eligible to take part in the trial. At this appointment, we will perform a number of tests including taking blood samples, checking your heart and carrying out a physical examination.
- If results from your screening appointment show you are eligible for the trial, you will be invited to take part.
- If you do decide to take part, the trial will involve:
- A stay of up to 5 days/4 nights in our clinical facility based in London Bridge.
- Receiving a single dose of the study drug through an intravenous infusion. We will conduct a number of assessments (like those we did at screening) to check how well you tolerate the study drug, and how effective the study drug is at lowering ‘bad’ cholesterol.
- After your stay with us, you will be required to return for 9 follow-up visits over the year.
- After the End of Study visit, you will continue to take part in a long-term follow-up study, which will monitor your safety and effectiveness of the study drug for a total of 15 years after the date of the first administration of the study drug.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You must be male or female between 18 and 65 years.
- You must have a body mass index (BMI) between 18kg/m2 and 40kg/m2 inclusive.
- You must be diagnosed with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD).
- You must be taking a statin, which is a cholesterol-lowering medication, or have a history of not tolerating these medicines. Statins include, Lipitor (torvastatin), Lescol (fluvastatin), Lipostat (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin).
- You must not be currently taking a PCSK9 inhibitor, such as Praluent (alirocumab), Repatha (evolocumab), or Leqvio (inclisiran) to lower cholesterol.
- Male participants must be either surgically sterile or must agree to use condoms and refrain from donating sperm for 90 days after the study drug administration.
- Female participants cannot be pregnant or capable of getting pregnant (post-menopausal or surgically sterile).
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested.
Clinical trial reimbursement
In recognition of the time involved in taking part in the trial, you will receive up to £2,450 on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the number of visits you have to attend and the time you commit to the study.
Clinical trial dates
Please call a member of the recruitment team on 020 7042 5800 to discuss study dates, or register to receive a call.
Approval
The contents of this email have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
In the event of any safety issues following study drug administration, you may be required to remain resident in the unit until resolution of [such][any] safety issues, after which you will be discharged from the unit.
Ref: C23021_Jun_2024 (email_website_advert text)
