Recruiting Adults With High Cholesterol

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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.

Duration of Stay

The trial will involve a stay of up to 4 nights and 9 follow-up visits.

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.

Location

We are based in London Bridge near both the Underground and overhead train Stations.
Our unit address is:   Richmond Pharmacology 1A Newcomen Street (Corner of Newcomen and Borough High Street) London SE1 1YR Please note the postcode will take you 5 minutes down the road from the clinic, I would use the map below as a reference (the clinic is on Borough High St, just up from Tesco and opposite the road from Foxtons)

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)

Trial code:
C24018

Speak to a member of our Volunteer Recruitment Team

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Call: 020 7042 5800

Comments from volunteers

Thanks very much to the Volunteer Recruitment Team. I am so excited to be part of this trial. I can’t thank you and your colleagues enough for all your help, professionalism, and kindness.

Steve K

Unbelievable service! They looked after me so well, and I would recommend them to anyone interested in participating in a clinical trial. I want to thank all the staff at trials4us for their continued efforts and for looking after me so well.

Chas

Very impressive. Thank you for taking care of me and for the valuable service you offer.

Joann

Very professional environment in the heart of London to conduct studies that help discover the medicines of the future.

James

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Recruiting people with type 2 diabetes

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Duration of stay
You will need to attend an in-person visit, In total, you will come to the research unit at least once.
View trial dates
Ages
18-70
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
£1,000
Ages
C23017
Smoking Restrictions
Smokers and non-smokers included
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Email us
Call: 020 7042 5800

Study Summary

We are conducting a study for participants with genetically diagnosed alpha-1 antitrypsin deficiency (Alpha 1) who are interested in participating in future gene editing clinical trials.
In this study, we are recruiting participants with Alpha 1 (with a known or suspected PiZZ mutation) aged 18 to 70. We will give you a tour of the clinical trials unit and conduct a number of clinical assessments to establish your current health status.
This study is to help participants with Alpha 1 decide if they want to participate in future gene editing clinical trials.

If you are interested in participating in this patient engagement study

  • You will need to attend an in-person visit, we will give you a tour of the clinical trial unit and perform tests to check your general health to obtain a clinical baseline.
  • The tests can be spread over multiple days (if required).
  • You will have a follow-up call with a doctor a week after the in-person visit.
  • This means the whole process takes approximately 1 week.

Who can take part?

We will check your suitability for the clinical trial using the following criteria:
  • You are aged between 18 to 70 years (inclusive).
  • You must have been diagnosed with alpha-1 antitrypsin deficiency (Alpha 1) (with a known or suspected PiZZ mutation).
  • You must be able and willing to provide informed consent.
  • You must be willing and able to comply with study assessments.
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 and want to find out more.

Study payment

In recognition of the time and effort involved in taking part in the study, you will receive £150 on completion of the study, provided you comply fully with all the study requirements.

Study dates

Following the completion of your registration form, a member of our recruitment team will contact you via phone and email to inform of the available 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.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C23017_MAR_2024 (email_website_advert text)
Register now

Speak to a member of our Volunteer Recruitment Team

Call: 020 7042 5800