Non-Alcoholic Fatty Liver Disease Trial, Recruiting (NCT04371042)

Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT04371042 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Non-Alcoholic Fatty Liver Disease

Printed from Voxsanity (voxsanity.com.au) — NCT04371042 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Non Alcoholic Fatty Liver Disease

Who may be able to join

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 must be 18 years of age or older
You have been diagnosed with a form of non-alcoholic fatty liver disease (NAFLD), which may include simple fat build-up in the liver, liver inflammation caused by fat (NASH), cirrhosis related to metabolism, or liver cancer linked to NAFLD
Your NAFLD diagnosis is supported by a liver biopsy, blood tests, and/or imaging scans (such as an ultrasound)
You drink no more than 21 units of alcohol per week (for men) or 14 units per week (for women), and you have not had a period of heavy, sustained drinking in the past 5 years
You previously had Hepatitis C but were successfully treated with newer antiviral medicines, and your virus has been undetectable for more than 6 months
You have risk factors for NAFLD (such as diabetes, metabolic syndrome, obesity, or psoriasis) but do not currently show signs of fatty liver on an ultrasound scan

Who may not be able to join:

You are unwilling or unable to give your informed consent to take part in the trial
You drink more than 21 units of alcohol per week (for men) or 14 units per week (for women), or you have a history of sustained heavy drinking in the past 5 years
You have been diagnosed with Type 1 diabetes
You do not meet the inclusion criteria listed above, or the trial investigator considers you unsuitable for the study (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 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +390631051

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: NCT04371042

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase: Not Applicable

Status: Recruiting

Condition: Non-Alcoholic Fatty Liver Disease

Trial contact: +390631051

More information: https://clinicaltrials.gov/study/NCT04371042

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 must be 18 years of age or older
You have been diagnosed with a form of non-alcoholic fatty liver disease (NAFLD), which may include simple fat build-up in the liver, liver inflammation caused by fat (NASH), cirrhosis related to metabolism, or liver cancer linked to NAFLD
Your NAFLD diagnosis is supported by a liver biopsy, blood tests, and/or imaging scans (such as an ultrasound)
You drink no more than 21 units of alcohol per week (for men) or 14 units per week (for women), and you have not had a period of heavy, sustained drinking in the past 5 years
You previously had Hepatitis C but were successfully treated with newer antiviral medicines, and your virus has been undetectable for more than 6 months
You have risk factors for NAFLD (such as diabetes, metabolic syndrome, obesity, or psoriasis) but do not currently show signs of fatty liver on an ultrasound scan

Who may not be able to join:

You are unwilling or unable to give your informed consent to take part in the trial
You drink more than 21 units of alcohol per week (for men) or 14 units per week (for women), or you have a history of sustained heavy drinking in the past 5 years
You have been diagnosed with Type 1 diabetes
You do not meet the inclusion criteria listed above, or the trial investigator considers you unsuitable for the study (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 28 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

Not Applicable

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Registry

ClinicalTrials.gov

Start date

1 September 2019

Est. completion

31 December 2035

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Registry creation

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.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 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.

View original record on ClinicalTrials.gov