Printed from Voxsanity (voxsanity.com.au) — NCT06632444 — 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:
You are 18 years old or older (or the legal adult age in your country) at the time you give consent
You have been diagnosed with MASH (a liver condition also known as non-alcoholic fatty liver disease) with a disease activity score of 4 or higher
Your body weight has been stable, meaning it has changed by less than 5% in the 3 months before screening, or between your previous liver biopsy and the start of the trial
You are willing to keep your diet and physical activity levels consistent throughout the whole trial
Note: Additional inclusion criteria may apply — confirm with the trial site
Who may not be able to join:
Your liver blood test results at screening show certain abnormalities, such as significantly elevated liver enzymes, a low platelet count, or other signs that your liver is not functioning normally (confirm with trial site for specific values)
You have any history or current signs of a liver disease other than MASH
You have been diagnosed with liver cirrhosis (the most advanced stage of liver scarring, known as stage F4)
You have been diagnosed with, or have a history of, liver cancer (hepatocellular carcinoma)
You have had, or are planning to have, a liver transplant
You are unable or unwilling to have a liver biopsy as part of the trial, if a suitable previous biopsy is not available
You have a history of high blood pressure in the liver (portal hypertension) or signs of serious liver failure
Your liver disease severity score (called a MELD score) is 12 or higher
Note: Additional exclusion criteria may apply — confirm with the trial site
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 12 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.
Concord Repatriation General Hospital, Concord, New South Wales
1800271035
Nepean Hospital, Kingswood, New South Wales
1800271035
Liverpool Hospital, Liverpool, New South Wales
1800271035
Westmead Hospital, Westmead, New South Wales
1800271035
Sunshine Coast University Hospital, Birtinya, Queensland
1800271035
Monash Health, Clayton, Victoria
1800271035
Austin Health, Heidelberg, Victoria
1800271035
Royal Melbourne Hospital, Parkville, Victoria
1800271035
Royal Perth Hospital, Perth, Western Australia
1800271035
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: NCT06632444
Sponsor: Boehringer Ingelheim
Phase: Phase 3
Status: Recruiting
Condition: Non-Alcoholic Fatty Liver Disease
Trial contact: 1-800-243-0127
More information: https://clinicaltrials.gov/study/NCT06632444
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:
You are 18 years old or older (or the legal adult age in your country) at the time you give consent
You have been diagnosed with MASH (a liver condition also known as non-alcoholic fatty liver disease) with a disease activity score of 4 or higher
Your body weight has been stable, meaning it has changed by less than 5% in the 3 months before screening, or between your previous liver biopsy and the start of the trial
You are willing to keep your diet and physical activity levels consistent throughout the whole trial
Note: Additional inclusion criteria may apply — confirm with the trial site
Who may not be able to join:
Your liver blood test results at screening show certain abnormalities, such as significantly elevated liver enzymes, a low platelet count, or other signs that your liver is not functioning normally (confirm with trial site for specific values)
You have any history or current signs of a liver disease other than MASH
You have been diagnosed with liver cirrhosis (the most advanced stage of liver scarring, known as stage F4)
You have been diagnosed with, or have a history of, liver cancer (hepatocellular carcinoma)
You have had, or are planning to have, a liver transplant
You are unable or unwilling to have a liver biopsy as part of the trial, if a suitable previous biopsy is not available
You have a history of high blood pressure in the liver (portal hypertension) or signs of serious liver failure
Your liver disease severity score (called a MELD score) is 12 or higher
Note: Additional exclusion criteria may apply — confirm with the trial site
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 12 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇧🇬 Bulgaria
🇨🇦 Canada
🇨🇱 Chile
🇨🇳 China
🇨🇿 Czechia
🇫🇷 France
🇬🇪 Georgia
🇩🇪 Germany
🇭🇺 Hungary
🇮🇳 India
🇮🇹 Italy
🇯🇵 Japan
🇯🇴 Jordan
🇰🇿 Kazakhstan
🇲🇾 Malaysia
🇲🇽 Mexico
🇳🇱 Netherlands
🇳🇿 New Zealand
🇵🇱 Poland
Puerto Rico
🇷🇴 Romania
🇸🇦 Saudi Arabia
🇸🇬 Singapore
🇿🇦 South Africa
🇰🇷 South Korea
🇪🇸 Spain
🇨🇭 Switzerland
🇹🇼 Taiwan
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score; Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH; Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH
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: 12 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.