Printed from Voxsanity (voxsanity.com.au) — NCT06318169 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
Men or non-pregnant women between 18 and 80 years old at the time of signing the consent form
People who have had a liver biopsy confirming a specific liver condition called MASH, with a moderate level of liver scarring (classified as stage F2 or F3)
People with a body mass index (BMI) of 25 or above (or 23 or above for participants of Asian background) — BMI is a measure based on height and weight
Who may not be able to join:
People who have a long-term liver disease other than MASH
People whose screening liver biopsy shows advanced scarring of the liver (cirrhosis)
People who have type 1 diabetes, or type 2 diabetes that is not well managed
People whose liver enzyme levels (ALT or AST) are very high — specifically at or above 250 units per litre (confirm with trial site if unsure what this means for your situation)
People taking high-dose vitamin E (more than 400 IU per day) or a medication called pioglitazone must have been on a stable dose for at least 6 months before the screening visit
Important: Other criteria not listed here may also apply. Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Clinical Trials, 89bio, Inc.
89bio Clinical Study Site, South Brisbane, Queensland
89bio Clinical Study Site, Adelaide, South Australia
89bio Clinical Study Site, Bedford Park, South Australia
89bio Clinical Study Site, Clayton, Victoria
89bio Clinical Study Site, Heidelberg, Victoria
89bio Clinical Study Site, Perth, Western Australia
89bio Clinical Study Site, Fitzroy,
89bio Clinical Study Site, Murdoch,
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · 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
Trial contact: 888-662-6728 (U.S. Only)
More information: https://clinicaltrials.gov/study/NCT06318169
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
Men or non-pregnant women between 18 and 80 years old at the time of signing the consent form
People who have had a liver biopsy confirming a specific liver condition called MASH, with a moderate level of liver scarring (classified as stage F2 or F3)
People with a body mass index (BMI) of 25 or above (or 23 or above for participants of Asian background) — BMI is a measure based on height and weight
Who may not be able to join:
People who have a long-term liver disease other than MASH
People whose screening liver biopsy shows advanced scarring of the liver (cirrhosis)
People who have type 1 diabetes, or type 2 diabetes that is not well managed
People whose liver enzyme levels (ALT or AST) are very high — specifically at or above 250 units per litre (confirm with trial site if unsure what this means for your situation)
People taking high-dose vitamin E (more than 400 IU per day) or a medication called pioglitazone must have been on a stable dose for at least 6 months before the screening visit
Important: Other criteria not listed here may also apply. Always verify eligibility with the trial site directly before applying.
Access in Australia: 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 doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 23 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
89bio, Inc.
Registry
ClinicalTrials.gov
Start date
13 March 2024
Est. completion
1 February 2029
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇦 Canada
🇨🇿 Czechia
🇫🇷 France
🇬🇪 Georgia
🇩🇪 Germany
Hong Kong
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇯🇵 Japan
🇲🇽 Mexico
🇳🇱 Netherlands
🇵🇱 Poland
Puerto Rico
🇸🇬 Singapore
🇿🇦 South Africa
🇰🇷 South Korea
🇪🇸 Spain
🇹🇼 Taiwan
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52; Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52; Time to First Occurrence of Disease Progression
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.