Printed from Voxsanity (voxsanity.com.au) — NCT06419374 — 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:
People who are male or non-pregnant female, aged 18 to 75 years old at the time of signing the consent form
People who have been diagnosed with type 2 diabetes for at least 3 months before the screening visit, or who have at least 2 metabolic risk factors (confirm with trial site)
People whose liver biopsy has confirmed a specific stage of liver scarring (called F4 fibrosis) related to a condition called MASH (a type of fatty liver disease), with compensated cirrhosis (meaning the liver is scarred but still functioning)
People whose body mass index (a measure of body weight relative to height) is 25.0 or above (or 23.0 or above for Asian participants) and below 50.0
Who may not be able to join:
People who have a liver condition other than MASH
People who have had, or show signs of, serious liver failure or complications (known as hepatic decompensation)
People who have had, or show signs of, liver cancer
People who have type 1 diabetes, or whose type 2 diabetes is not well controlled
People whose liver enzyme levels (ALT or AST) are at or above a certain high level found in blood tests (confirm with trial site)
People taking high-dose vitamin E (more than 400 IU per day) who have not been on a stable dose for at least 6 months before screening
Important: 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 26 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, Hoffmann-La Roche
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: NCT06419374
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/NCT06419374
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:
People who are male or non-pregnant female, aged 18 to 75 years old at the time of signing the consent form
People who have been diagnosed with type 2 diabetes for at least 3 months before the screening visit, or who have at least 2 metabolic risk factors (confirm with trial site)
People whose liver biopsy has confirmed a specific stage of liver scarring (called F4 fibrosis) related to a condition called MASH (a type of fatty liver disease), with compensated cirrhosis (meaning the liver is scarred but still functioning)
People whose body mass index (a measure of body weight relative to height) is 25.0 or above (or 23.0 or above for Asian participants) and below 50.0
Who may not be able to join:
People who have a liver condition other than MASH
People who have had, or show signs of, serious liver failure or complications (known as hepatic decompensation)
People who have had, or show signs of, liver cancer
People who have type 1 diabetes, or whose type 2 diabetes is not well controlled
People whose liver enzyme levels (ALT or AST) are at or above a certain high level found in blood tests (confirm with trial site)
People taking high-dose vitamin E (more than 400 IU per day) who have not been on a stable dose for at least 6 months before screening
Important: 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 26 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
24 May 2024
Est. completion
1 June 2028
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇧🇪 Belgium
🇧🇷 Brazil
🇧🇬 Bulgaria
🇨🇦 Canada
🇫🇷 France
🇩🇪 Germany
Hong Kong
🇭🇺 Hungary
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇲🇽 Mexico
🇳🇱 Netherlands
🇵🇱 Poland
Puerto Rico
🇸🇬 Singapore
🇰🇷 South Korea
🇪🇸 Spain
🇹🇼 Taiwan
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Proportion of Participants Achieving Fibrosis Regression; Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
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: 26 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.