ObesityLLIFTNCT04616664
Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"
An observational study of Obesity and NASH - Nonalcoholic Steatohepatitis, run by University Hospital, Lille at 7 sites in France.
Trial summary
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, NASH - Nonalcoholic Steatohepatitis
- How many people
- 158 participants
- Where
- 7 sitesFrance
- Study dates
- 16 Feb 2021to 17 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are followed in the cardiology, endocrinology, hepatology, hepatologic surgery and bariatric surgery units of the CHU de Lille and regional centers and presente type 2 diabetes or blood pressure hypertension associated with increased hepatic enzyme. Patients will be referred to the hepatology units and included in the study
Who may be able to join
- Patients with 1 at least of the following metabolic criteria :
- BMI > 30 kg/m²,
- Type 2 diabetes (glycemia > 1.26 g/L or under therapy)
- hypertension (> 140 mmHg / 90 mmHg or under therapy) associated with increased hepatic enzymes
- Indication of NAFLD evaluation
- Patients written consent
- Affiliated to a social insurance
Who cannot join
- Contraindications for liver biopsy or MRI.
- Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease.
- alcohol consumption higher than 140g/week for women and 210g/week for men
- Previous history of alcohol abuse (addiction).
- Eluding stent < 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks.
- Hepatocellular carcinoma
Show all 10Show fewer
- Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
- Pregnant or breastfeeding women.
- Drug abuse within the past year.
- Mentally unbalanced patients, under supervision or guardianship
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Chu Amiens Picardie
Amiens
CH ARRAS
Arras
CH de Douai
Douai
CH LENS
Lens
Hop Claude Huriez Chu Lille
Lille, 59037
GHIRCL saint Philibert
Lomme
Ch Valenciennes
Valenciennes
About this study
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.
The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.
- Conditions
- Obesity, NASH - Nonalcoholic Steatohepatitis
- Keywords
- NAFL, NASH screening, metabolic syndrome, Diagnostic Biomarker, non-invasive biomarker
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score
The variables constituting the calculation algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,...) and genetic polymorphism
Measured: Baseline
Secondary outcomes (2)
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score
The variables constituting the algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,..), genetic polymorphism.
Measured: Baseline
Assessment of the correlation between the LLIFT score and the NAS score
The NAS score is a stratification based on steatosis, ballooning and lobular inflammation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start16 Feb 2021
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- RHU PreciNASH Task 1.4, Région Nord-Pas de Calais, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Lassailly, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616664
- Sponsor's protocol ID
- 2019_45
- Other IDs
- 2020-A01991-38
- Acronym
- LLIFT
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"
- ClinicalTrials.gov ID
- NCT04616664
- Acronym / sponsor ID
- LLIFT / 2019_45
- Conditions
- Obesity, NASH - Nonalcoholic Steatohepatitis
- Keywords
- NAFL, NASH screening, metabolic syndrome, Diagnostic Biomarker, non-invasive biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- RHU PreciNASH Task 1.4, Région Nord-Pas de Calais, France
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 5 Nov 2020 (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.
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.
The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are followed in the cardiology, endocrinology, hepatology, hepatologic surgery and bariatric surgery units of the CHU de Lille and regional centers and presente type 2 diabetes or blood pressure hypertension associated with increased hepatic enzyme. Patients will be referred to the hepatology units and included in the study
Key inclusion criteria (7 listed)
- Patients with 1 at least of the following metabolic criteria :
- Indication of NAFLD evaluation
- Patients written consent
- Affiliated to a social insurance
Key exclusion criteria (10 listed)
- Contraindications for liver biopsy or MRI.
- Other confounding cause of liver disease (HCV, HBV, HCC, autoimmune liver disease, Hemochromatosis, Wilson disease.
- alcohol consumption higher than 140g/week for women and 210g/week for men
- Previous history of alcohol abuse (addiction).
- Eluding stent < 6 month or acute coronary syndrome within 1 year or non-eluding stent within 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score
Time frame: Baseline
The variables constituting the calculation algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,...) and genetic polymorphism
2 secondary outcomes
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score
Time frame: Baseline
Assessment of the correlation between the LLIFT score and the NAS score
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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. This study is not recruiting at the moment.
Guillaume Lassailly, MD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and NASH - Nonalcoholic Steatohepatitis, run by University Hospital, Lille at 7 sites in France.
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 7 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score (time frame: Baseline). 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 23 Dec 2025.