If this is close to home

This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.

  • Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
  • Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
  • Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
  • Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
  • Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14

Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.

Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

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

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Boehringer Ingelheim
Registry number NCT06632444
Started 14 October 2024 Today 16 October 2026 Estimated completion 27 December 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Concord Repatriation General Hospital Concord NSW Completed
Nepean Hospital Kingswood NSW Recruiting
Liverpool Hospital Liverpool NSW Recruiting
Westmead Hospital Westmead NSW Recruiting
Sunshine Coast University Hospital Birtinya QLD Recruiting
Monash Health Clayton VIC Recruiting
Austin Health Heidelberg VIC Recruiting
Royal Melbourne Hospital Parkville VIC Recruiting
Royal Perth Hospital Perth WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1800

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.

Inclusion criteria:

1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent

2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4

3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used

4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply

Exclusion criteria:

1. Any of the following liver laboratory test abnormalities at screening:

* Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)

* Platelet count \<140 000/mm\^3 (\<140 GI/L)

* Alkaline phosphatase \>2x upper limit of normal (ULN)

* Abnormal synthetic liver function as defined by screening central laboratory evaluation:

* Albumin below \<3.5 g/dL (35.0 g/L)

* OR International normalised ratio (INR) of prothrombin time \>1.3

* OR total serum bilirubin concentration ≥1.5x ULN

2. Any history or evidence of acute or chronic liver disease other than MASH

3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy

4. History of or current diagnosis of hepatocellular carcinoma

5. History of or planned liver transplant

6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.

7. History of portal hypertension or presence of decompensated liver disease

8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply

Dates on the record

Started 14 October 2024
Estimated completion 27 December 2031
Registry last updated 14 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 14 October 2026.
  • This page last checked by Voxsanity: 15 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.