Printed from Voxsanity (voxsanity.com.au) — NCT06528314 — 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:
(Group 1) You have confirmed liver scarring at the most advanced stage (cirrhosis), caused by a fatty liver disease related to metabolic conditions (NASH/MASH), diagnosed through a biopsy, with a certain level of disease activity shown by the biopsy results
(Group 2) You have advanced liver scarring (cirrhosis) caused by fatty liver disease related to metabolic conditions (NASH/MASH), confirmed either through a biopsy or through non-invasive tests (such as scans or blood tests)
In both groups, your liver is considered "compensated," meaning it is still functioning despite the scarring
Who may not be able to join:
Your liver disease is caused by something other than fatty liver disease related to metabolic conditions (for example, alcohol, a virus, or another condition)
You have Type 1 diabetes, or your Type 2 diabetes is not well controlled or stable
You have had, or currently have, serious liver complications where the liver has stopped working properly (known as decompensated liver disease) at any point in the past or present
Important: Other eligibility requirements 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 27 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.
Akero Clinical Study Site, Broadmeadow, New South Wales
Akero Clinical Study Site, Coffs Harbour, New South Wales
Akero Clinical Study Site, Kingswood, New South Wales
Akero Clinical Study Site, Liverpool, New South Wales
Akero Clinical Study Site, Westmead, New South Wales
Akero Clinical Study Site, Herston, Queensland
Akero Clinical Study Site, Adelaide, South Australia
Akero Clinical Study Site, Box Hill, Victoria
Akero Clinical Study Site, Clayton, Victoria
Akero Clinical Study Site, Epping, Victoria
Akero Clinical Study Site, Heidelberg, Victoria
Akero Clinical Study Site, Melbourne, Victoria
Akero Clinical Study Site, Murdoch, Western Australia
Akero Clinical Study Site, Nedlands, Western Australia
Akero Clinical Study Site, Perth, Western Australia
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: NCT06528314
Sponsor: Akero Therapeutics, Inc
Phase: Phase 3
Status: Recruiting
Condition: Non-Alcoholic Fatty Liver Disease
Trial contact: 650-487-6488
More information: https://clinicaltrials.gov/study/NCT06528314
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:
(Group 1) You have confirmed liver scarring at the most advanced stage (cirrhosis), caused by a fatty liver disease related to metabolic conditions (NASH/MASH), diagnosed through a biopsy, with a certain level of disease activity shown by the biopsy results
(Group 2) You have advanced liver scarring (cirrhosis) caused by fatty liver disease related to metabolic conditions (NASH/MASH), confirmed either through a biopsy or through non-invasive tests (such as scans or blood tests)
In both groups, your liver is considered "compensated," meaning it is still functioning despite the scarring
Who may not be able to join:
Your liver disease is caused by something other than fatty liver disease related to metabolic conditions (for example, alcohol, a virus, or another condition)
You have Type 1 diabetes, or your Type 2 diabetes is not well controlled or stable
You have had, or currently have, serious liver complications where the liver has stopped working properly (known as decompensated liver disease) at any point in the past or present
Important: Other eligibility requirements 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 27 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
Akero Therapeutics, Inc
Registry
ClinicalTrials.gov
Start date
4 September 2024
Est. completion
1 February 2030
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇧🇷 Brazil
🇨🇦 Canada
🇨🇱 Chile
🇫🇷 France
🇩🇪 Germany
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇲🇽 Mexico
🇵🇱 Poland
Puerto Rico
🇰🇷 South Korea
🇪🇸 Spain
🇨🇭 Switzerland
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
15 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.; Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
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: 27 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.