Recruiting Adults With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

You will receive £4,150 for taking part
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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.

Duration of Stay

You will be asked to attend 3 screening appointments and 2 dosing sessions, with some overnight stays, and will be required to return for 5 follow-up visits.

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.

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

The trial will take place on the below time periods, for your in-house stays of 4 days / 3 nights. You will then also be required to attend 7 follow-up sessions. Dates for follow up visits will be discussed with you by our team.

  • 24th – 27th November 2025 & 16th – 19th February 2026
  • 8th – 11th December 2025 & 2nd – 5th March 2026
  • 3rd – 6th February 2026 & 28th April – 1st May 2026
  • 17th – 20th February 2026 & 12th – 15th May 2026
  • 8th – 11th March 2026 & 31st May – 3rd June 2026
  • 23rd – 26th March 2026 & 15th – 18th June 2026

Dates are subject to change. Please call a recruitment team member on 020 7042 5802 to discuss study dates, or register to receive a call back.

Trial code:
C24017

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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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