Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT04442334 Sponsor: Newcastle University Condition: Non-Alcoholic Fatty Liver Disease
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Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT04442334
Recruiting Not Applicable

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, or are suspected to have, a liver condition called NAFLD (a build-up of fat in the liver not caused by alcohol), confirmed by one of the following: a past liver biopsy showing NAFLD; a current or planned liver biopsy for suspected NAFLD supported by blood or scan results; or scan evidence of advanced liver scarring (cirrhosis) with no other known cause, plus at least 2 signs of "metabolic syndrome" such as a large waist size, high blood sugar or diabetes, abnormal cholesterol or fat levels in the blood, or high blood pressure.
  • You drink, on average, fewer than 21 units of alcohol per week (if male) or fewer than 14 units per week (if female), and have not had a long history of heavy drinking in the past 5 years.

Who may not be able to join:

  • You are unwilling or unable to give your consent to take part in the study.
  • You drink more alcohol per week than the limits described above, or have had a sustained period of heavy drinking in the last 5 years.
  • You have been diagnosed with Type 1 diabetes.
  • You have any other long-term liver condition other than NAFLD.
  • You have used certain medications known to cause fat build-up in the liver in the past 12 months (such as long-term steroids, amiodarone, methotrexate, tamoxifen, tetracycline, high-dose oestrogens, or valproic acid) (confirm with trial site).
  • You have a medical reason why a liver biopsy would not be safe for you (confirm with trial site).
  • You have recently started or changed the dose of certain supplements or medications (such as high-dose Vitamin E, ursodeoxycholic acid, or silymarin) within the past 3 months (confirm with trial site).
  • You do not speak English and do not have access to a suitable interpreter, as the study involves collecting information about diet, exercise, and symptoms.
  • You do not meet the required inclusion criteria, or the study doctor feels you are not suitable for the trial.

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

Principal Investigator: Quentin M Anstee, MBBS, PhD, Newcastle University

Phone: +44(0)191 20 87012

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.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Newcastle University
Registry
ClinicalTrials.gov
Start date
1 May 2015
Est. completion
31 December 2030

Where this trial is recruiting

🇧🇪 Belgium 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇹 Portugal 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇬🇧 United Kingdom

Primary endpoints

Detailed Characterisation of the NAFLD Patient Phenotype

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