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Duration of stay
You will be in the VT-10201 study for 1 year after receiving the investigational medication and attend approximately 10 follow-up visits.
Ages
18-65
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
To be confirmed
Smoking Restrictions
Non-Smokers
Trial Code
C23021 (Cohort 1)
Paid on completion of the study.
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Clinical trial summary

Richmond Pharmacology is taking part in a clinical research study called the VT-10201 study. The purpose of this study is to see if an investigational medication, called VERVE-102, is safe and can help to lower the levels of low-density lipoprotein cholesterol (LDL-C) in people who have familial hypercholesterolaemia (FH) or premature coronary artery disease (CAD).

VERVE-102 is an investigational medication that is designed to lower the levels of LDL-C in the blood permanently. It does this by making a change to the DNA in a gene called “PCSK9” to stop it from working. Stopping the PCSK9 gene from working is known to lower LDL-C levels.

Some people who are born with PCSK9 genes that do not work have extremely low levels of LDL-C and are protected from developing atherosclerosis. They do not have any significant health problems as a result of the PCSK9 gene not working. Medications that block PCSK9 (called “PCSK9 inhibitors”) have been approved to treat patients with elevated LDL-C levels. PCSK9 inhibitors have been widely studied in patients and have been shown to be safe and to decrease the likelihood of having a heart attack or stroke.

About the VT-10201 study

  • As part of the VT-10201 study, you will need to stay overnight at the study centre, 1 day before and 2 days after receiving the investigational medication. If you live nearby the study centre, you may not need to stay overnight the day before you receive your dose of VERVE-102. The investigational medication is given as an intravenous (IV) infusion into a vein in your arm.
  • If you take part, you will be in the VT-10201 study for 1 year after receiving the investigational medication and attend approximately 10 follow-up visits. Up to 6 different dose levels of VERVE-102 may be tested in the study to try and find a dose that is safe and works to lower LDL-C.
  • After the study is over, you will be asked to join a second, long-term follow-up study to help researchers understand the safety of the investigational medication over a longer period of time. The study doctor will share the details of this with you.
Register for this trial

Are you interested in taking part?

You may be able to take part if you:

  • Are 18-65 years of age
  • Have FH or premature CAD
  • Have high levels of LDL-C

Clinical trial payment

To be confirmed.

Clinical trial dates

Admission: 27th August

Dismissal: 31st August

Follow-up visits: 4th, 10th, 17th, 24th September, 26th october, 26th November 2024, 22nd February, 24th May and 27th August 2025.

Please call a member of the recruitment team on 0207 042 5800 to discuss alternative 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.

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: VT-10201_UK_Participant Invitation Letter_V1.0_28Nov2023

Register for this trial
If you would like to speak to a member of our Volunteer Recruitment Team, call us on 020 7042 5800
Register for this clinical trial

Contact our Volunteer Recruitment Team

Ref: C23021 (Cohort 1) - (email_website_advert text)

Comments from volunteers

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

The initial process to get accepted on the trials was easy, and the payment was prompt and precise. The staff here at the clinic are lovely, very professional, helpful, and understanding.

Elisabeth

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