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.

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.

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).

This section will provide you with information about the study medicines and how they work. This will help you understand the potential effects that the medicines may have on your liver health and alcohol use.

Cagrilintide is a medicine similar to a hormone called amylin, which is produced in the body together with insulin. Amylin is produced when you eat and makes you feel full for longer. Cagrilintide acts in a similar way to amylin. Cagrilinitide is not registered or available for sale to the general public.

Semaglutide is a medicine used for the treatment of type 2 diabetes and weight management. It is similar to a hormone called glucagon-like peptide-1 (GLP-1), which is made in your body after you eat a meal. This hormone stops you from feeling hungry, affecting both your appetite and your body’s ability to regulate its blood sugar levels.
Semaglutide works in a similar manner to GLP-1. Semaglutide is approved in Australia to treat insufficiently controlled Type 2 Diabetes at a dose of 1mg, and at a higher dose (2.4mg) is approved for weight management.

CagriSema is a new medicine being tested, which is a combination of cagrilintide and semaglutide. CagriSema is not registered or available for sale to the general public.

NNC0194-0499 is a new investigational medicine, similar to a hormone called fibroblast growth factor-21 that is made naturally in the body and produced by the liver after eating food, when the levels of sugar and fat in your blood are high. It can decrease the levels of fat and sugar in the blood. NN0194-0499 is not registered or available for sale to the general public.

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.

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.

This study is being sponsored by Novo Nordisk, a global healthcare company dedicated to innovative treatments for serious chronic diseases. 

Here is a list of all of the sites who are currently recruiting for this study:

New South Wales

• Holdsworth House - Holdsworth House Medical Practice, Level 3/26 College St, Darlinghurst, NSW, 2010

Coming soon:

• St George Hospital - Level 5, Suite 503/131 Princes Highway, Kogarah, NSW, 2217
• Westmead Hospital - Cnr Hawkesbury Road and Darcy Rd, Westmead, NSW, 2145 
• St Vincent Hospital - 41 Victoria Parade, Fitzroy, VIC, 3065
• Box Hill Hospital - 8 Arnold St, Box Hill, VIC, 3128

Visit our Evrima Help Centre to view our FAQs, or if you wish to connect with our
patient experience team.

Click here to view the Study’s ANZCTR page (Australian New Zealand Clinical Trials
Registry)

Click here for clinicaltrials.gov page