This study aims to find out whether a medicine called Survodutide helps people with non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH) and F2 or F3 stage liver fibrosis to improve their liver function.
About this study
The purpose of the study is to identify a new treatment for fatty liver disease and to see if Survodutide injections (study medication) are safe and effective in treating fatty liver disease. The study is a placebo-controlled study and will compare the effect of the study medication with a placebo. The study will further assess if the study medication can delay or prevent liver-related complications and death in participants with fatty liver disease.
Anticipated enrolment close date: December 2026
Who can take part
You may be eligible to participate if:
- you have been diagnosed with MASH and have moderate to advanced liver fibrosis (F2 or F3), confirmed by a recent liver biopsy
- your body weight has been stable (no more than 5% change) over the past 3 months
- you are willing and able to give written informed consent and follow all study instructions, including self-injections or having someone assist you
You may not be able to participate if you:
- have type 1 diabetes and uncontrolled type 2 diabetes (very high blood sugar)
- have significant heart, kidney, or other serious medical problems that affect your health or safety
What's involved for you
This study has two parts and you may be involved for up to 7 years. For the first year of the study, you may be required to visit the study site every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year, you will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.
Required assessments and tests include:
- physical examination (height, weight, waist and hip circumference, blood pressure)
- electrocardiogram (ECG)
- urine analysis
- FibroScan
- liver biopsy
- laboratory tests
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.