Non-alcoholic Fatty LiverNCT06819917
Identification of Liver Fibrosis Biomarkers
An observational study of Non-alcoholic Fatty Liver and Non-Alcoholic Fatty Liver Disease, run by Roche Diagnostics GmbH at 2 sites in 2 countries.
Trial summary
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- What is being tested?
- Identification of liver fibrosis biomarkers
- How many people
- 575 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients will be recruited in the study using 2 different approaches. The first is patients who are referred to clinical centers as part of an existing assessment where a decision to perform a liver biopsy has been made. This decision can be based on standard liver function tests AST, ALT, FIB-4 , fibroscan or other factors. In addition, patients F0-F2 who underwent a biopsy within the last 6 months but at least 1 month ago, can be recalled to join the study. If patients agree to participate in the study, they will be recalled to the site for a blood draw and ultrasound scan (if patients consent for further use, to be performed latest 6 months after biopsy).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre Hospital
Copenhagen
Camilla Ramvold, camilla.renata.ramvold@regionh.dk
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
Susan Depoix, susan.depoix@unimedizin-mainz.de
About this study
Official title: Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Non-alcoholic fatty liver disease (NAFLD) represents a major risk for CLD and it is becoming the most common chronic liver condition with an estimated 25% global prevalence. Progression to non-alcoholic steatohepatitis (NASH) occurs in approx. 1 of 5 NAFLD patients and due to the rapidly rising etiology of end-stage liver disease, is currently the second most common etiology of hepatocellular carcinoma (HCC) requiring liver transplantation. Liver biopsy, currently the gold-standard for grading disease activity and staging fibrosis, is invasive, costly and at risk for sampling error. Due to the number of patients diagnosed with fibrosis and since fibrosis stage is prognostic of mortality and drives patient management, it is important to develop noninvasive yet accurate diagnostic tools that can identify fibrosis stage. The purpose of this study is to obtain a panel of clinically well characterized blood specimens to identify novel biomarkers to be used as an aid in diagnosis to assess the stage of clinically significant hepatic fibrosis in patients with signs or symptoms of NAFLD (NAFL/NASH). In addition, quantitative ultrasound (QUS) based approaches combined with artificial intelligence (AI) algorithms will be explored for assessing the stage of fibrosis.
- Conditions
- Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- Being tested
- Identification of liver fibrosis biomarkers
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of liver fibrosis biomarkersOther
Patients will be recruited in the study using 2 different approaches. The first is patients who are referred to clinical centers as part of an existing assessment where a decision to perform a liver biopsy has been made (routine biopsy). This decision can be based on standard liver function tests AST, ALT, FIB-4 (performed up to 8 months before biopsy), fibroscan (performed up to 6 months before biopsy) or other factors.
In addition, patients F0-F2 who underwent a biopsy within the last 6 months but at least 1 month ago, can be recalled to join the study. If patients agree to participate in the study, they will be recalled to the site for a blood draw and ultrasound scan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Significant Fibrosis (≥F2)
The study aims to identify significant liver fibrosis (stage F2 or higher) through various biomarkers. This involves the comparison of biomarkers to biopsy results to determine their predictive value .
Measured: Through study completion, an average of 1 year.
Identification of Advanced Fibrosis (≥F3)
he study aims to identify advanced liver fibrosis (stage F3 or higher) through various biomarkers. The assessment will determine the predictive value of these biomarkers for advanced stages of fibrosis (F3-F4)
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
Performance of Biomarkers in Clinically Relevant Subpopulations
Exploratory analysis to evaluate the performance of identified biomarkers within specific patient sub-groups. This aims to understand the variability and reliability of biomarkers across different demographics and clinical characteristics.
Measured: Through study completion, an average of 1 year.
Evaluation of Biomarker Panels
This measure involves evaluating individual or combined biomarkers identified through literature review, pathway analysis, and experimental programs using a panel of well-characterized blood specimens (serum, plasma, whole blood, and buffy coat).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 575 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roche Diagnostics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819917
- Sponsor's protocol ID
- RD006521
- Status last verified
- May 2026
- First submitted
- 22 Jan 2025
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis
- ClinicalTrials.gov ID
- NCT06819917
- Acronym / sponsor ID
- RD006521
- Conditions
- Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 575 participants (estimated)
- Lead sponsor
- Roche Diagnostics GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Non-alcoholic fatty liver disease (NAFLD) represents a major risk for CLD and it is becoming the most common chronic liver condition with an estimated 25% global prevalence. Progression to non-alcoholic steatohepatitis (NASH) occurs in approx. 1 of 5 NAFLD patients and due to the rapidly rising etiology of end-stage liver disease, is currently the second most common etiology of hepatocellular carcinoma (HCC) requiring liver transplantation. Liver biopsy, currently the gold-standard for grading disease activity and staging fibrosis, is invasive, costly and at risk for sampling error. Due to the number of patients diagnosed with fibrosis and since fibrosis stage is prognostic of mortality and drives patient management, it is important to develop noninvasive yet accurate diagnostic tools that can identify fibrosis stage. The purpose of this study is to obtain a panel of clinically well characterized blood specimens to identify novel biomarkers to be used as an aid in diagnosis to assess the stage of clinically significant hepatic fibrosis in patients with signs or symptoms of NAFLD (NAFL/NASH). In addition, quantitative ultrasound (QUS) based approaches combined with artificial intelligence (AI) algorithms will be explored for assessing the stage of fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in the study using 2 different approaches. The first is patients who are referred to clinical centers as part of an existing assessment where a decision to perform a liver biopsy has been made. This decision can be based on standard liver function tests AST, ALT, FIB-4 , fibroscan or other factors. In addition, patients F0-F2 who underwent a biopsy within the last 6 months but at least 1 month ago, can be recalled to join the study. If patients agree to participate in the study, they will be recalled to the site for a blood draw and ultrasound scan (if patients consent for further use, to be performed latest 6 months after biopsy).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of liver fibrosis biomarkersPatients will be recruited in the study using 2 different approaches. The first is patients who are referred to clinical centers as part of an existing assessment where a decision to perform a liver biopsy has been made (routine biopsy). This decision can be based on standard liver function tests AST, ALT, FIB-4 (performed up to 8 months before biopsy), fibroscan (performed up to 6 months before biopsy) or other factors. In addition, patients F0-F2 who underwent a biopsy within the last 6 months but at least 1 month ago, can be recalled to join the study. If patients agree to participate in the study, they will be recalled to the site for a blood draw and ultrasound scan. | Other | – |
Primary outcome
Identification of Significant Fibrosis (≥F2)
Time frame: Through study completion, an average of 1 year.
The study aims to identify significant liver fibrosis (stage F2 or higher) through various biomarkers. This involves the comparison of biomarkers to biopsy results to determine their predictive value .
Identification of Advanced Fibrosis (≥F3)
Time frame: Through study completion, an average of 1 year.
he study aims to identify advanced liver fibrosis (stage F3 or higher) through various biomarkers. The assessment will determine the predictive value of these biomarkers for advanced stages of fibrosis (F3-F4)
2 secondary outcomes
Performance of Biomarkers in Clinically Relevant Subpopulations
Time frame: Through study completion, an average of 1 year.
Evaluation of Biomarker Panels
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver and Non-Alcoholic Fatty Liver Disease, run by Roche Diagnostics GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Pujol Lopez, Dr. (+4915254994070, yara.pujol_lopez@roche.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Significant Fibrosis (≥F2) (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.