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Clinical trial summary
- We are recruiting male and female participants aged between 18 to 65 with Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- The intention of the trial is to study whether the investigational drug will reduce liver fat, liver injury, and liver scarring in patients with MASH.
- The trial drug will be given as an injection under the skin.
- During the trial, you will undergo several clinical assessments that will help us evaluate the safety of the trial drug (safety),how well you tolerate the trial drug (tolerability), how the trial drug works to change the liver fat (pharmacodynamics), and how long the drug stays in your body (pharmacokinetics).
- You will be reimbursed for your travel expenses and your time if you take part in this clinical trial.
This clinical trial will be divided into two parts:
Part B: In Part B there will be up to 28 participants with MASH. Each participant will receive two doses of the study treatment (12 weeks apart). This part will involve a screening period, a treatment period (during which you will receive two doses of the study treatment – trial drug or placebo) and a follow-up period.
If you are interested in taking part in this clinical trial:
- You will need to attend 3 screening appointments so we can check if you are suitable to take part in the trial. At these appointments, we will perform several assessments, including but not limited to taking blood, checking your heart, carrying out a physical examination and conducting scans of your liver. Eligible participants will also need to have a liver biopsy.
- If results from your screening appointments show you are suitable for the trial, you will be asked to undergo the treatment period where you will receive 2 doses of the study treatment 12 weeks apart. The study treatment will be given as an injection under the skin(subcutaneous).
- You will then be required to attend 5 follow-up visits over a period of 9 months.
- This means the trial will take approximately 58 weeks from your screening visit through to your final visit.
- During the trial, we will conduct a number of assessments (like those we did at screening) to check how safe the trial drug is, how well you tolerate multiple doses of the trial drug, how long the drug remains in your body and how it affects your body.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:
- You must be male or female between aged between 18 and 65 years.
- You must be diagnosed with Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- You must have a BMI between 30 and 40 kg/m2 at the first screening visit.
- You must be willing and able to comply with the study visits and study-related assessments and procedures.
- You must not have a history of significant multiple and/or severe allergies.
- You must not be pregnant or breastfeeding.
- Female participants of childbearing potential must be on effective contraception methods 2 months before dosing and must agree to use highly effective methods of contraception, for the duration of the trial and for at least 9 months after the last dose.
- Male participants must agree to use a condom, for the duration of the trial and for at least 9 months after the last dose.
Please note there are additional study criteria. 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.
Clinical trial payment
You will receive £4,150 (£2,766.67 trial payment and £1,383.33 compliance) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial 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 020 7042 5802 to discuss study dates, or register to receive a call back.
Approval
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 study.
Ref: C24017_Mar-2025 (email_website_advert text)
