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Clinical trial summary
We are conducting a clinical trial, called the Pulse-1 study. The Pulse-1 study is testing an investigational medicine to see if it is safe and if it will help lower cholesterol levels.
- In this clinical trial, we are recruiting male and female participants aged 18 to 70 with cholesterol that is too high (not at the medically recommended goal) even after working with healthcare providers to make lifestyle changes and taking medicines to lower cholesterol.
- To be eligible for this clinical trial, participants must have a history of high cholesterol levels or have already experienced a heart attack or stroke.
- You will be reimbursed for your time and commitment if you participate in this clinical trial.
If you are interested in participating in this trial:-
You will need to attend screening appointments so we can check if you are eligible to take part in the trial. At these appointments, 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 appointments 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.
- During your stay with us, you will receive a single dose of the study drug via intravenous infusion, and we will conduct a number of assessments (like those we did at screening) to check how well you tolerate the study drug, and to help us understand how long it takes for your body to process the study drug.
- 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 safety and effectiveness of the study drug for a total of 15 years after the date of the first administration of the study drug. Many of these visits can be done from your home.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You must be male or female aged 18 to 70 years.
- You must have refractory hypercholesterolemia. This means that your cholesterol is too high (not at medically recommended goal) even after working with your health care providers to make lifestyle changes and taking medicines to lower cholesterol. You must be on stable doses of your cholesterol medication for 30 days prior to screening. (cholesterol medications include statins and PCSK9 inhibitor)
- You must have a body mass index (BMI) between 18 kg/m2 and 40 kg/m2.
- 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 must be post-menopausal or premenopausal with infertility.
- You must not be a regular smoker for 3 months before the study.
An initial discussion surrounding potential eligibility will be conducted by one of our recruitment team members prior to screening if you are interested.
Clinical trial reimbursement
In recognition of the time involved in taking part in the trial, you will receive up to £2,400 on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the number of trial visits you have to attend and the time you commit to the trial.
Clinical trial dates
Admission: TBC
Dismissal: TBC
Follow-up visits: TBC
Please call a member of the recruitment team on 0207 042 5800 to discuss study dates.
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 safety issues, after which you will be discharged from the unit.
Ref: C23018_Jun_2024 (email_website_advert text)
