Trial Code
C24012
Ages
Over 18 years of age
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
£2,450
Nicotine Restrictions
Nicotine users and non-nicotine users included
Duration of stay
This will involve a stay of 3 days /2 nights in our clinical research unit. You will come to the research unit approximately 12 times.
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Paid on completion of the study.
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Clinical trial summary
- We are conducting a clinical study for an investigational drug that could be used to treat people with refractory dyslipidaemia.
- Refractory dyslipidaemia is a condition associated with high levels of fats such as cholesterol and triglycerides in the blood even after working with healthcare providers to make lifestyle changes and taking medicines to lower cholesterol.
- The clinical study involves a screening appointment, a treatment period where you will receive the study drug infusion and an outpatient follow-up period.
- Several safety assessments will be conducted including repeated blood sampling to discover how safe and well-tolerated the drug is and how it affects the body.
- In this clinical study we are recruiting approximately 24 patients over 18 years of age with a diagnosis of dyslipidaemia despite receiving medicines to lower fat levels.
- You will be paid for your time if you take part in this clinical study.
If you are interested in participating in this study:
- You will need to attend a screening appointment so we can check if you are eligible to take part in the study. At this appointment, we will take blood, check your heart, conduct imaging tests and carry out a physical examination.
- If results from your screening appointment show you are suitable for the study, you will be invited to take part.
- This will involve a stay of 3 days /2 nights in our clinical research unit where you will receive a single dose of the study drug as an infusion in your arm (intravenously). We will conduct several assessments to check how well you tolerate the investigational drug, and to help us understand how safe the investigational drug is and how it affects the body. However, you may be asked to remain in the unit for longer if required.
- After your stay with us, you will be required to return to the unit for follow-up visits over the next 2 days to have blood tests and check-ups.
- The outpatient follow-up appointments will be conducted over 1 year. These follow-ups will happen at least weekly for the first month, once a month for the second and third months (M2 and M3), and every 3 months for the next 9 months (M6, M9, and M12).
- This means the whole process takes approximately 13.5 months including your screening visit through to your final visit.
- In total, if you are included in the clinical study you will come to the research unit approximately 12 times.
- After your last study visit, you will be invited to continue to take part in a long-term follow-up study, which will monitor the 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 study using the following criteria:
- You are a male or female over 18 years of age.
- You must have high levels of fats in your blood despite working with healthcare providers to make lifestyle changes and taking medicines to lower cholesterol.
- You are receiving standard-of-care treatment and are on a stable dose, with no planned dose increase before screening and during the study participation.
- You must not be on a corticosteroid or anabolic agent therapy.
- You must not receive any vaccinations 30 days before the study start day.
- You must not have received another investigational drug within 30 days before dosing on Day 1.
- You must not consume any alcohol within 2 weeks before your dosing visit and 2 weeks after dosing on Day 1.
- You must not be pregnant or breastfeeding.
- Female participants of childbearing potential are not eligible for this study.
- Male participants must be willing to use appropriate barrier contraception from the point of consenting and for the duration of the study until the final study visit, with female partners of child-bearing potential.
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.
Study payment
In recognition of the time involved in taking part in the study, you will receive £2,450 (£1,633 study payment and £817 bonus) on completion of the study, provided you comply fully with all the study requirements. This amount is based on the anticipated study plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Dates
Please call a recruitment team member on 02070425800 to discuss study dates, or register to receive a call back.
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 study.
Ref: C24012_Nov-2024 (email_website_advert text)
If you would like to speak to a member of our Volunteer Recruitment Team, call us on 020 7042 5800
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