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 Akero Therapeutics, Inc

Registry number NCT06215716

Started 1 December 2023 Today 16 October 2026 Estimated completion 1 February 2033

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Akero Clinical Study Site	Broadmeadow	NSW	Recruiting
Akero Clinical Study Site	Coffs Harbour	NSW	Recruiting
Akero Clinical Study Site	Kogarah	NSW	Recruiting
Akero Clinical Study Site	Liverpool	NSW	Recruiting
Akero Clinical Study Site	Penrith	NSW	Recruiting
Akero Clinical Study Site	Westmead	NSW	Recruiting
Akero Clinical Study Site	Adelaide	SA	Recruiting
Akero Clinical Study Site	Caulfield South	VIC	Recruiting
Akero Clinical Study Site	Epping	VIC	Recruiting
Akero Clinical Study Site	Frankston	VIC	Recruiting
Akero Clinical Study Site	Heidelberg	VIC	Recruiting
Akero Clinical Study Site	Melbourne	VIC	Recruiting
Akero Clinical Study Site	Murdoch	WA	Recruiting
Akero Clinical Study Site	Nedlands	WA	Recruiting
Akero Clinical Study Site	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 to 80 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 1650

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:

* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.

* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.

* Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

* Steatosis (scored 0 to 3),

* Ballooning degeneration (scored 0 to 2), and

* Lobular inflammation (scored 0 to 3).

* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.

* Presence of cirrhosis on liver biopsy (fibrosis stage 4).

* Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Dates on the record

Started 1 December 2023

Estimated completion 1 February 2033

Registry last updated 15 October 2026

Checked by Voxsanity 15 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 15 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.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · 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

More information: https://clinicaltrials.gov/study/NCT06215716

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
- Steatosis (scored 0 to 3),
- Ballooning degeneration (scored 0 to 2), and
- Lobular inflammation (scored 0 to 3).
Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

Exclusion Criteria:

Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
Presence of cirrhosis on liver biopsy (fibrosis stage 4).
Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

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 registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.