If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Phase 3 study for people with Non-Alcoholic Fatty Liver Disease
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Concord Repatriation General Hospital | Concord | NSW | Completed |
| Nepean Hospital | Kingswood | NSW | Recruiting |
| Liverpool Hospital | Liverpool | NSW | Recruiting |
| Westmead Hospital | Westmead | NSW | Recruiting |
| Monash Health | Clayton | VIC | Recruiting |
| Austin Health | Heidelberg | VIC | Recruiting |
| Royal Melbourne Hospital | Parkville | VIC | Recruiting |
| Royal Perth Hospital | Perth | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion criteria:
1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
5. Further inclusion criteria apply.
Exclusion criteria:
1. Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
2. Model of end-stage liver Disease (MELD) score \>12 due to liver disease
3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
* Portal hypertension-related upper gastrointestinal (GI) bleeding
* Ascites
* Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
4. Any of the following lab test result at screening
* Albumin below \<3.5 g/dL (\<35.0 g/L)
* International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants
* Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL.
* Alkaline phosphatase \>1.5x ULN
* PLT \<100,000/µL (\<100 GI/L)
5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN
9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
10. History of liver transplantation or listed for liver transplantation
11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
12. Further exclusion criteria apply
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 14 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.