Receive a payment of £1,368 for the time involved in taking part in this study
We are conducting a clinical trial for a potential new medicine that could be used to treat patients with non-alcoholic steatohepatitis (NASH) which is a form of non-alcoholic fatty liver disease. In this trial, we are assessing to see if the new investigational drug is beneficial in patients with non-alcoholic steatohepatitis.
We will aim to look at how the body handles (distributes, breaks down, and eliminates) the new drug. This is studied by measuring the amount of drug that gets into your blood, urine, and liver after dosing (pharmacokinetics (PK) of the new investigational drug).
We will also aim to see if the new drug reduces the amount of a particular protein (known as HSD17B13 (“HSD”)) in the blood of humans, as it did in the studies in animals.Register for this clinical trial
If you are interested in participating in the trial:-
- This clinical trial will involve you staying with us for a few days (see below) at our private clinical research unit in London Bridge.
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment we perform a number of tests including, taking blood, checking your heart, and carrying out a physical examination to see if you will be OK to take part in the clinical trial. Eligible participants may also need to have a liver biopsy.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- There may be some times that you will remain overnight for safety or logistical requirements but this will be discussed further during your initial visit. After your stay with us, you will be required to return for further appointments on Day 15, Day 29, Day 43, Day 57, Day 99, Day 113, Day 169, Day 225, Day 281, and Day 337 of the trial. This means the whole trial takes approximately 14 and a half months from your screening visit through to your final visit.
- In total, if you are included in the clinical trial you will come to the research unit 13 times.
- During your stay with us, you will receive two doses (on Day 1 and Day 85) of the investigational medicine subcutaneously (i.e. injection just under the skin) and we will conduct a number of assessments (like those we did at screening) to check how well you tolerate the new medicine and to help us understand how long it takes for your body to get rid of the new medicine and how effective the new drug is in reducing the amount of the target protein in the blood.
Clinical trial dates
Screening now. For further details on trial dates, contact a member of the recruitment team on 020 7042 5800 (select option 1) or register to receive a callback.
Who can take part?
We will check your suitability for the study using the following criteria:-
- You are a male or female aged between 18 to 65 years inclusive.
- You have a Body Mass Index (BMI) within the range of 18.0 and 40.0 kg/m2.
- You must have non-alcoholic steatohepatitis and no other underlying medical conditions that may affect the trial or put you at any significant risk.
- You must not test positive for alcohol or show any evidence of alcohol abuse for 3 months during the past year prior to screening.
- You must not test positive for drugs or show any evidence of drug abuse 12 months prior to screening.
- You must not have changes (i.e., initiation, discontinuation, or dose changes) in the following prescription medications/treatments within 30 days prior to screening:
- Anti-hypertensive prescription medication
- Cholesterol-lowering prescription medication
- Diabetes prescription medication (except insulin adjustments)
- Vitamin E treatment (in the last 6 months)
- Female participants of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting 14 days before the first dose and until study completion.
- Male participants must be willing to use appropriate barrier contraception for 5 days after each dose with female partners of child-bearing potential, including partners that are already pregnant.
- Female participants must not be pregnant or breastfeeding.
- You must not have an intolerance to subcutaneous injection(s) or significant abdominal scarring that could potentially hinder the investigational medicine administration or evaluation of the investigational medicine administration site.
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.
Clinical trial Payment
In recognition of the time involved in taking part in this study, you will receive £1,368 (£912 clinical trial payment and £456 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.
Contact our Volunteer Recruitment team
For more information call +44 (0) 20 7042 5800 or email:Register your interest in this clinical trial
You may be required to remain resident in the unit until the resolution of any safety issues, after which you will be discharged from the unit.
The contents of this page 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.
Ref: C20017_Feb2021 (email_website_advert text)