This trial is testing a study drug to see if it can safely reduce the harmful effects of alcohol on the liver.
The study aims to reduce a protein thought to contribute to liver damage and scarring. Researchers will assess the drug’s safety, tolerability, and effectiveness, and determine the best dose. Eligible participants will be placed by chance into a trial treatment group to receive either the study drug or a placebo (inactive drug).
Who can take part
You may be able to take part if you:
- are 18 to 65 years of age
- are willing to comply with study requirements, including genetic testing and adherence to the protocol schedule
- have drunk alcohol in the last 4 months
- Additional criteria apply
What's involved
Enrolled participants will
- receive the trial drug or placebo as 2 shots into the skin every 4 weeks for 6 months
- have visits with tests to check their health and the liver
- Undergo ECG, Fibroscan and blood tests
- Completion of questionnaires
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.