Recruiting Adults With Dyslipidaemia

You will receive £2,450
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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.

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.

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.

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)

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)

Trial code:
C24012

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)
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Speak to a member of our Volunteer Recruitment Team

Call: 020 7042 5800