Printed from Voxsanity (voxsanity.com.au) — NCT06632457 — 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 of age or older (or the legal age of consent in your country, if higher)
Your body mass index (BMI) is 27 or above (or 25 or above if you are of Asian background) — BMI is a measure based on your height and weight
You have been diagnosed with a specific liver condition called MASH cirrhosis, where scarring of the liver is present but the liver is still functioning (confirm with trial site)
Certain scan or imaging results show a specific level of fat in your liver, or you have had a recent liver biopsy showing liver fat or inflammation (confirm with trial site for exact requirements)
There are additional inclusion requirements not listed here (confirm with trial site)
Who may not be able to join:
You have drunk heavily in the last 5 years — above roughly 14 drinks per week for women or 21 drinks per week for men, for more than 3 months in a row
Your liver disease has reached a certain level of severity based on a medical scoring system called the MELD score (confirm with trial site)
You have had, or currently have, serious liver complications such as internal bleeding related to liver pressure, fluid build-up in the abdomen, or a type of brain confusion caused by liver disease
Certain blood test results at the screening stage fall outside acceptable ranges, including low protein levels, abnormal clotting, high bilirubin, high liver enzymes, or low platelet counts (confirm with trial site for exact values)
You have another long-term liver disease, such as autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, or a genetic iron storage disorder, among others
You have hepatitis B or a history of long-term hepatitis B infection
You currently have hepatitis C infection
Your liver enzyme levels (AST and/or ALT) are more than 5 times the normal upper limit
Your liver disease is caused by alcohol or by a medication or drug
You have previously had a liver transplant or are currently on a waiting list for one
You have previously had a procedure to manage high blood pressure in the liver (such as a TIPS procedure)
There are additional exclusion requirements not listed here (confirm with 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 22 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
Nepean Hospital, Kingswood, New South Wales
1800271035
Liverpool Hospital, Liverpool, New South Wales
1800271035
Westmead Hospital, Westmead, New South Wales
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: NCT06632457
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/NCT06632457
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 of age or older (or the legal age of consent in your country, if higher)
Your body mass index (BMI) is 27 or above (or 25 or above if you are of Asian background) — BMI is a measure based on your height and weight
You have been diagnosed with a specific liver condition called MASH cirrhosis, where scarring of the liver is present but the liver is still functioning (confirm with trial site)
Certain scan or imaging results show a specific level of fat in your liver, or you have had a recent liver biopsy showing liver fat or inflammation (confirm with trial site for exact requirements)
There are additional inclusion requirements not listed here (confirm with trial site)
Who may not be able to join:
You have drunk heavily in the last 5 years — above roughly 14 drinks per week for women or 21 drinks per week for men, for more than 3 months in a row
Your liver disease has reached a certain level of severity based on a medical scoring system called the MELD score (confirm with trial site)
You have had, or currently have, serious liver complications such as internal bleeding related to liver pressure, fluid build-up in the abdomen, or a type of brain confusion caused by liver disease
Certain blood test results at the screening stage fall outside acceptable ranges, including low protein levels, abnormal clotting, high bilirubin, high liver enzymes, or low platelet counts (confirm with trial site for exact values)
You have another long-term liver disease, such as autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, or a genetic iron storage disorder, among others
You have hepatitis B or a history of long-term hepatitis B infection
You currently have hepatitis C infection
Your liver enzyme levels (AST and/or ALT) are more than 5 times the normal upper limit
Your liver disease is caused by alcohol or by a medication or drug
You have previously had a liver transplant or are currently on a waiting list for one
You have previously had a procedure to manage high blood pressure in the liver (such as a TIPS procedure)
There are additional exclusion requirements not listed here (confirm with 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 22 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
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and 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: 22 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.