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Liver Disease Study

The aim of this study is to evaluate the effectiveness of an investigational medication in the treatment of non-alcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease (NAFLD).

Eligibility
  • 18 years or older.
  • Had a liver biopsy confirming NASH (or are willing to have one within 180 days prior to the screening visit).
  • Moderate to significant liver fibrosis (stage 2 or stage 3) as confirmed by a liver biopsy.
Location
  • NSW
  • QLD
  • VIC
  • SA
  • WA
Duration
  • Approximately 4 years
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Liver circle

If you take part in the research study, there will be:

Reimbursement of costs

For out-of-pocket expenses, such as travel and parking.

Convenience

There are no overnight stays, and some study visits can be conducted over the phone.

Free study-related medical care

Be among the first to access potential new research treatments before they are widely available.

Contribution to medical research

Help advance knowledge and treatment outcomes for people with period and pelvic pain.

Expert medical monitoring

Receive top-tier medical care and monitoring from experienced healthcare professionals.

Register your interest now

or scroll down to read our study FAQs

Study Guide

01

Who can take part in this study?

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To be eligible for participation, you will need to meet all the following: 

  • Aged 18 or over. 
  • You have had a liver biopsy confirming NASH or are willing to have one within 180 days prior to the screening visit.
  • Moderate to significant liver fibrosis (stage 2 or stage 3), as confirmed by a liver biopsy.

02

Who is unable to take part in this study?

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Who is unable to take part in this study?
Unfortunately, if you meet any of the following, this study is not the right fit for you:

  • Documented causes of chronic liver disease other than NAFLD. 
  • History or presence of Type 1 diabetes. 
  • You have experienced a significant heart event such as a heart attack or stroke in the last 90 days 

    Please note that there may be other reasons that you are not deemed eligible to participate beyond what is listed here. 

03

How long will the study take?

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If you agree to take part, and this study is suitable for you, your participation is expected to last up to 5 years (approximately 257 weeks- 4 years and 11 months).This includes:

  • Informed consent: Before participating, you will be given detailed information about this study and then asked to provide written consent.
  • Screening period (10 weeks): You will undergo diagnostic evaluations to determine your eligibility to participate in this study. 
  • Randomisation: You will be assigned to either the placebo group or the study drug group.
  • Treatment period (240 weeks): Using a pen injector, you will self-administer the trial product once weekly on the same day of the week. During this time, you will be required to attend the study site approximately 10 times, as well as undertake phone visits, so the research team can monitor your progress and collect data.
  • Follow-up period (7 weeks): The research team will stay in touch with you to ensure your well-being, answer any questions you may have, and track how the trial product is working for you. 

04

What is the purpose of this study?

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The study aims to evaluate whether the investigational medication can slow or reverse NASH to a less severe stage.

The investigational medication has shown promising results in resolving NASH. Likewise, it is currently approved in Australia for the treatment of both Type 2 diabetes and weight management, as it helps regulate appetite and prevent overeating.

05

What is non-alcoholic steatohepatitis (NASH)?

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Non-alcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD), a range of conditions that occur when excess fat builds up in the liver. People with NASH not only have excessive deposits of fat in their liver, but also inflammation and damage. It is unknown why some people develop NASH and others do not, and it often presents with few or no symptoms.

However, it is common and largely undiagnosed in people with obesity, high cholesterol, and Type 2 diabetes. It is important to note, though NASH is difficult to spot, it is still very much a dangerous disease - if left unchecked, it can progress to cirrhosis, a serious condition in which the liver becomes permanently scarred and unable to function properly. 

06

Why is this study important?

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Currently, the only way to treat non-alcoholic steatohepatitis (NASH) is through lifestyle interventions and by managing other contributing medical conditions, such as diabetes, high cholesterol, and excess body fat.

However, NASH can cause weakness, tummy pain, and extreme tiredness, thereby limiting a person’s ability to exercise and lose weight. Likewise, if left unchecked, NASH can cause the liver to become permanently scarred and unable to function properly.

As NAFLD has an estimated worldwide prevalence of 24%, there is a significant unmet need for a safe and effective treatment option that helps people reduce their risk of developing end-stage liver disease. 

07

Where is my nearest study site?

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We are currently recruiting for this study in the following locations:

  • NSW: 
    • Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Westmead NSW 2145.
    • Liverpool Hospital, Corner of Elizabeth and Goulburn Streets, Liverpool NSW 2170.
    • Nepean Hospital, Derby Street, Kingswood, NSW 2747.
  • QLD: 
    • Gold Coast University Hospital, 1 Hospital Blvd, Southport, QLD, 4215.
  • VIC: 
    • St Vincent’s Hospital Melbourne, 41 Victoria Parade. 
    • Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084.
  • SA: 
    • Lyell McEwin Hospital, Haydown Road, Elizabeth Vale SA 5112.
    • Royal Adelaide Hospital, Port Road SA 5000.
  • WA:
    • Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch WA 6150.

08

What if I have other questions about the study?

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We are here for you! Click or tap the 'Contact us' button below to send an email to our Patient Experience team:

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