A study to test whether different doses of BI 456906 are effective in people with a liver disease called non-alcoholic steatohepatitis (NASH) and liver fibrosis.
About this study
NASH is an advanced form of non-alcoholic fatty liver disease that belongs to the most common liver diseases in developed countries. It occurs when fat is deposited in the liver (steatosis), the liver becomes inflamed (hepatitis) and this leads to scar formation in the liver (fibrosis). The research study is testing a potential new treatment for NASH. The new treatment is called BI 456906.
The purpose of this study is to:
- Test the effect of three different doses of the study drug called BI 456906, given one time a week by an injection under the skin in participants with NASH and fibrosis.
- Test the safety, tolerability (side effects) and effectiveness of the study drug BI 456906 compared to placebo in participants with NASH and fibrosis.
Anticipated enrolment close date: 30 June 2022
Who can take part
Inclusion criteria
- Participants must be willing to undergo liver biopsies and MRI scans
- People with a BMI of greater than 25
- People with a body weight greater than 70kg
Exclusion criteria
People with any of the following conditions cannot take part in the study:
- Significant alcohol intake or other forms of chronic liver disease
- A major depressive disorder
- Major cardiac issues
What's involved
Participation in the study lasts approximately 60 weeks and require up to 34 study visits.
Participants may need to come to the study site more than once to complete all procedures planned at that visit - for example, at visits when liver ultrasound, magnetic resonance imaging or liver biopsy are performed.
Approximately 60% of the study visits are anticipated to be conducted at the RMH. The remaining study visits will be conducted remotely via a video call.
- Liver biopsy and MRI at week 28
- Fibroscans 4 times throughout trial
- Regular ECGs, blood tests and other measurements
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.