Phase 3 study for people with Non-Alcoholic Fatty Liver Disease

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 12 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor 89bio, Inc.

Registry number NCT06318169

Started 13 March 2024 Today 16 October 2026 Estimated completion 1 February 2029

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
89bio Clinical Study Site	Brisbane	QLD	Recruiting
89bio Clinical Study Site	Herston	QLD	Recruiting
89bio Clinical Study Site	South Brisbane	QLD	Recruiting
89bio Clinical Study Site	Adelaide	SA	Recruiting
89bio Clinical Study Site	Bedford Park	SA	Recruiting
89bio Clinical Study Site	Clayton	VIC	Recruiting
89bio Clinical Study Site	Heidelberg	VIC	Recruiting
89bio Clinical Study Site	Perth	WA	Recruiting
89bio Clinical Study Site	Fitzroy	VIC	Recruiting
89bio Clinical Study Site	Murdoch	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice

Who can join

Age 18 Years to 80 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 1350

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 80 years (inclusive) at time of signing the informed consent form (ICF)

* Biopsy-confirmed MASH with fibrosis stage F2 or F3

* Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).

Key Exclusion Criteria:

* Chronic liver diseases other than MASH

* Evidence of cirrhosis on screening liver biopsy

* Have type 1 diabetes or poorly controlled type 2 diabetes

* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)

* Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.

Dates on the record

Started 13 March 2024

Estimated completion 1 February 2029

Registry last updated 5 October 2026

Checked by Voxsanity 12 October 2026

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.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT06318169

Sponsor: 89bio, Inc.

Phase: Phase 3

Status: Recruiting

Condition: Non-Alcoholic Fatty Liver Disease

More information: https://clinicaltrials.gov/study/NCT06318169

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Key Inclusion Criteria:

Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
Biopsy-confirmed MASH with fibrosis stage F2 or F3
Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants).

Key Exclusion Criteria:

Chronic liver diseases other than MASH
Evidence of cirrhosis on screening liver biopsy
Have type 1 diabetes or poorly controlled type 2 diabetes
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.