Blood markers to detect liver scarring in fatty liver disease

Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis

This will test whether blood markers can detect liver scarring in adults with NAFLD or NASH who are having or recently had a liver biopsy.

Quick facts

• Study type: Observational
• Enrollment: 575 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Roche Diagnostics GmbH (industry)
• Locations: 2 sites (Copenhagen and 1 other locations)
• Trial ID: NCT06819917 on ClinicalTrials.gov

What this trial studies

This observational effort will collect blood samples from adults with NAFLD/NASH (including MASLD/MASH) who are scheduled for liver biopsy or had a biopsy within the past six months and will compare biomarker results to biopsy fibrosis stage, Fib-4, and FibroScan readings. Eligible participants are aged 18–75 with BMI ≤45 and must not have other known liver disease etiologies or be pregnant or lactating. The goal is to identify blood biomarkers associated with fibrosis stage to support noninvasive diagnosis and risk stratification. The project is sponsored by Roche Diagnostics and is taking place at centers in Copenhagen and Mainz.

Who should consider this trial

Good fit: Adults 18–75 with NAFLD/NASH (or MASLD/MASH) who are scheduled for biopsy or had a biopsy within the last six months, with available Fib-4 or FibroScan results and BMI ≤45.

Not a fit: People with other causes of liver disease, pregnant or breastfeeding women, vulnerable or institutionalized individuals, or those outside the age/BMI criteria are unlikely to benefit.

Why it matters

Potential benefit: If successful, the tests could allow earlier and less-invasive detection of liver fibrosis and reduce the need for liver biopsy.

How similar studies have performed: Previous research has identified promising blood biomarker panels for fibrosis, but no single blood test has yet replaced biopsy as the definitive standard.

Eligibility criteria

Inclusion Criteria:

* Patients scheduled for biopsy (or F0-F2 patients that underwent biopsy within the last 6 months but at least 1 month ago) suspected of having hepatic fibrosis due to NAFLD (NAFL/NASH) or patients with MASLD or MASH
* Any FIB-4 value available
* Any Fibroscan value available
* Written and signed informed consent present
* Patients aged ≥ 18 years to ≤ 75 years at the time of the blood draw
* Body Mass Index (BMI) ≤ 45 kg/m²

Exclusion Criteria:

* Vulnerable person: person deprived of liberty by a judicial or administrative decision and/or person under psychiatric care
* Self-reported pregnancy or lactating females
* Disease related to other etiologies, including alcoholic liver disease (alcoholic steatohepatitis), MetALD, specific etiology SLD (e.g. DILI or monogenic disease), cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, human immunodeficiency virus, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency
* Any type of carcinoma, unless it is at least 5 years in remission
* Prior liver transplant
* Evidence of any other unstable or, untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric disorder. Medically controlled comorbidities can be allowed
* Self-reported alcohol consumption greater 30 g/day (males) 20 g/day (females)
* Recent myocardial infarction (within last 6 months)
* Inability to have a liver biopsy, or provide blood sample in a fasted status
* F0-F2 recalled patients with +/- 5% change in weight between the biopsy and study inclusion

Where this trial is running

Copenhagen and 1 other locations

• Hvidovre Hospital — Copenhagen, Denmark (RECRUITING)
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Germany (RECRUITING)

Study contacts

• Study coordinator: Ioanna Rokai, MSc.

Conditions: Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis