Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT06819917 Sponsor: Roche Diagnostics GmbH Condition: Non-Alcoholic Fatty Liver Disease
Back to Non Alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT06819917
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:

  • People who are scheduled for a liver biopsy, or who had a liver biopsy between 1 and 6 months ago (for those with early-stage liver scarring), where the biopsy relates to suspected liver scarring caused by a fatty liver condition (NAFLD, NAFL, NASH, MASLD, or MASH)
  • People who have a FIB-4 score on record (a blood test result used to assess liver health)
  • People who have a FibroScan result on record (a non-invasive scan result that measures liver stiffness)
  • People who have signed a written consent form to participate
  • People aged 18 to 75 years old at the time their blood sample is taken
  • People with a Body Mass Index (BMI) of 45 or below (a measure of body weight relative to height)

Who may not be able to join:

  • People who are currently in legal detention or receiving involuntary psychiatric care
  • People who are pregnant or currently breastfeeding (based on self-report)
  • People whose liver condition is caused by something other than fatty liver disease — for example, alcohol-related liver disease, viral hepatitis, drug-induced liver injury, a genetic liver condition, autoimmune hepatitis, HIV, Wilson's disease, haemochromatosis, alpha-1 antitrypsin deficiency, primary biliary cirrhosis, or primary sclerosing cholangitis
  • People who have or have had any type of cancer, unless that cancer has been in full remission for at least 5 years
  • People who have previously had a liver transplant
  • People who have another serious medical condition that is unstable or untreated — including conditions affecting the immune system, blood, hormones, digestive system, nervous system, or mental health (note: well-controlled conditions may still be permitted — confirm with trial site)
  • People who report drinking more than 30 grams of alcohol per day (for men) or more than 20 grams per day (for women)
  • People who have had a heart attack within the past 6 months
  • People who are unable to have a liver biopsy or unable to provide a blood sample while fasting
  • People with early-stage liver scarring (F0–F2) who are being recalled for the study, if their body weight has changed by more than 5% since their original biopsy

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
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: +4915254994070

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
Roche Diagnostics GmbH
Registry
ClinicalTrials.gov
Start date
1 February 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇩🇰 Denmark 🇩🇪 Germany

Primary endpoints

Identification of Significant Fibrosis (≥F2); Identification of Advanced Fibrosis (≥F3)

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: 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.

View original record on ClinicalTrials.gov