Study Information for Participants: Investigating a potential new treatment for those with Alcohol-Related Liver Disease.
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study is looking at the effects of three study medicines, either alone or in combination, on alcohol use and liver damage (i.e. changes in the level of scar tissue).
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
- Sydney
- Kogarah
- Westmead
- Melbourne
- Box Hill
Who can participate?
To take part in this study, you will need to meet all the following criteria (other criteria apply):
- Aged 18 years or older.
- BMI 25 or higher
- reported history of high alcohol intake for 5 years or more
- Meet specific liver health criteria as assessed during screening.
Please note, additional eligibility criteria apply.
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- You have a liver condition unrelated to alcohol use.
- You are pregnant or breastfeeding.
- You have participated in another clinical trial within the past 6 months.
Please note, additional eligibility criteria apply.
What is involved?
Total participation is expected to last approximately 39 weeks.
- This includes 4 weeks of screening to assess participants eligibility,
- For eligible participants, there will be a 28 week treatment period (receiving the investigational medications via subcutaneous injection (just under the skin),
- On completion of the treatment period, there will be a 7-week follow-up period which includes appointments to monitor your progress.
Participation in this research is voluntary, and you may withdraw from the study at any time.
If you take part in the research study, there will be:
- Reimbursement of costs: For out-of-pocket expenses, such as travel and parking
- Contribution: Be part of a global community of 240 people across 13 different countries investigating potential new medications for alcohol-related liver disease.
- Expert study-related medical care: Expert study-related medical care and monitoring from experienced healthcare professionals, and support to reduce your alcohol consumption
What is Alcohol-related Liver Disease (ALD)
Alcohol-related liver disease (ALD) is liver damage caused by excessive alcohol consumption over time, leading to inflammation, scarring, and impaired liver function. This long-term alcohol misuse can reduce the liver’s ability to renew itself, which can lead to a buildup of scar tissue that may result in permanent damage to the liver. It is not known why some people develop ALD while others don’t, but what is clear is that the risk of developing this disease increases with the amount of alcohol consumed.
Why is this study important?
ALD is a serious condition with limited treatment options. This study seeks to develop potential new therapies to improve liver health and overall quality of life for people affected by alcohol-related liver disease.
Who is involved?
This study is being sponsored by Novo Nordisk, a global healthcare company dedicated to innovative treatments for serious chronic diseases.
FOR MORE INFORMATION OR TO REGISTER YOUR INTEREST, VISIT ALDSTUDY.COM
This trial has been approved by an independent ethics committee
Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey.
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