Printed from Voxsanity (voxsanity.com.au) — NCT06215716 — 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:
Men and women (who are not pregnant or breastfeeding) between 18 and 80 years old at the time of their screening visit
People who have had, or currently have, at least 2 of these 4 conditions: obesity, abnormal cholesterol or fats in the blood, high blood pressure, or high fasting blood sugar — or people who have type 2 diabetes
Group 1: People who have had a liver biopsy (tissue sample taken from the liver) within the last 180 days that confirmed a specific type of liver disease called NASH/MASH, with moderate liver scarring (stage 2 or 3) and a disease activity score of 4 or higher showing signs of fat buildup, liver cell damage, and inflammation (confirm with trial site)
Group 2: People who have had a liver biopsy within the last 180 days confirming stage 3 liver scarring — the activity score requirements are more flexible for this group (confirm with trial site)
Who may not be able to join:
People whose liver disease is caused by something other than the conditions described above (such as another underlying illness)
People whose liver biopsy shows the most advanced stage of liver scarring, known as cirrhosis (stage 4)
People who have type 1 diabetes, or type 2 diabetes that is not well controlled
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.
Akero Clinical Study Site, Broadmeadow, New South Wales
Akero Clinical Study Site, Coffs Harbour, New South Wales
Akero Clinical Study Site, Kogarah, New South Wales
Akero Clinical Study Site, Liverpool, New South Wales
Akero Clinical Study Site, Penrith, New South Wales
Akero Clinical Study Site, Westmead, New South Wales
Akero Clinical Study Site, Adelaide, South Australia
Akero Clinical Study Site, Caulfield South, Victoria
Akero Clinical Study Site, Epping, Victoria
Akero Clinical Study Site, Frankston, 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: NCT06215716
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/NCT06215716
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:
Men and women (who are not pregnant or breastfeeding) between 18 and 80 years old at the time of their screening visit
People who have had, or currently have, at least 2 of these 4 conditions: obesity, abnormal cholesterol or fats in the blood, high blood pressure, or high fasting blood sugar — or people who have type 2 diabetes
Group 1: People who have had a liver biopsy (tissue sample taken from the liver) within the last 180 days that confirmed a specific type of liver disease called NASH/MASH, with moderate liver scarring (stage 2 or 3) and a disease activity score of 4 or higher showing signs of fat buildup, liver cell damage, and inflammation (confirm with trial site)
Group 2: People who have had a liver biopsy within the last 180 days confirming stage 3 liver scarring — the activity score requirements are more flexible for this group (confirm with trial site)
Who may not be able to join:
People whose liver disease is caused by something other than the conditions described above (such as another underlying illness)
People whose liver biopsy shows the most advanced stage of liver scarring, known as cirrhosis (stage 4)
People who have type 1 diabetes, or type 2 diabetes that is not well controlled
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.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Akero Therapeutics, Inc
Registry
ClinicalTrials.gov
Start date
1 December 2023
Est. completion
1 February 2033
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇨🇦 Canada
🇫🇷 France
🇩🇪 Germany
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇲🇽 Mexico
🇵🇱 Poland
Puerto Rico
🇰🇷 South Korea
🇪🇸 Spain
🇨🇭 Switzerland
🇹🇼 Taiwan
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
15 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis; Event-free survival
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.