This study aims to find out whether a medicine called Survodutide helps people with non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH) and cirrhosis to improve their liver function.
About this study
This study is testing a medication called Survodutide to see if it is safe and effective for people with a fatty liver disease. This condition happens when fat builds up in the liver and causes scarring. The study will compare Survodutide with a placebo to see if it can help delay or prevent serious liver problems. Survodutide is not yet approved for treating this condition. Taking part in the study is voluntary, and all participants will continue to receive the best possible care throughout the study.
Anticipated enrolment close date: December 2026
Who can take part
You may be eligible to participate if you:
- have a body mass index (BMI) of 27 or higher (or 25 or higher if you are of Asian ethnicity)
- have a confirmed diagnosis of fatty liver disease with cirrhosis, based on a liver biopsy, imaging, or other medical tests
- are willing and able to follow the study requirements, including learning to give yourself weekly injections (or having someone do it for you), and following diet and lifestyle instructions
You may not be able to participate if you:
- have had serious liver complications, such as fluid in the abdomen (ascites), bleeding in the digestive tract from liver pressure, or confusion caused by liver problems (hepatic encephalopathy)
- have another liver disease like hepatitis B or C, autoimmune hepatitis, or genetic liver conditions (e.g., Wilson’s disease or haemochromatosis)
What's involved for you
This study will require your involvement for up to 4 and a half years. During this time, you will visit the study site or have a remote visit every 2, 4 or 6 weeks for about 1 year and 5 months. After this time, you will visit the trial site or have a remote visit every 3 months until the end of the study.
Required assessments and tests include:
- physical examinations (height, weight, waist and hip circumference, blood pressure)
- electrocardiogram (ECG)
- laboratory and pregnancy tests
- urine analysis
- liver biopsy
- FibroScan
- eye exam
- gastrointestinal endoscopy
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 an Australian registered and certified HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2025). This statement protects the interests of people who agree to participate in human research studies.