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 |
|---|---|---|---|
| 89bio Clinical Study Site | Adelaide | SA | Recruiting |
| 89bio Clinical Study Site | Fitzroy | Australia | Recruiting |
| 89bio Clinical Study Site | Greenslopes | Australia | Recruiting |
| 89bio Clinical Study Site | Heidelberg | VIC | Recruiting |
| 89bio Clinical Study Site | Herston | QLD | Recruiting |
| 89bio Clinical Study Site | Murdoch | Australia | Recruiting |
| 89bio Clinical Study Site | Perth | Australia | Recruiting |
| 89bio Clinical Study Site | South Brisbane | Australia | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 12 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.
Key Inclusion Criteria:
* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
Key Exclusion Criteria:
* Liver disorder other than MASH.
* History or evidence of hepatic decompensation.
* History or evidence of hepatocellular carcinoma.
* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
* Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.
Other protocol-defined inclusion and exclusion criteria may 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: 5 October 2026.
- This page last checked by Voxsanity: 12 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.