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CompletedNCT04616664LLIFTUpdated Dec 23, 2025

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 in Obesity and NASH - Nonalcoholic Steatohepatitis, sponsored by University Hospital, Lille. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
158
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Obesity
  • NASH - Nonalcoholic Steatohepatitis

Keywords

  • NAFL
  • NASH screening
  • metabolic syndrome
  • Diagnostic Biomarker
  • non-invasive biomarker
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 158 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
158 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

07

Study locations

7 sites
  • Chu Amiens Picardie
    Amiens, France
  • CH ARRAS
    Arras, France
  • CH de Douai
    Douai, France
  • CH LENS
    Lens, France
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
  • GHIRCL saint Philibert
    Lomme, France
  • Ch Valenciennes
    Valenciennes, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04616664
Lead sponsor
University Hospital, Lille
Collaborators
RHU PreciNASH Task 1.4, Région Nord-Pas de Calais, France
Responsible party
Sponsor
First posted
Nov 5, 2020
Start date
Feb 16, 2021
Primary completion
Jan 17, 2024
Completion
Jan 17, 2024
Last update
Dec 23, 2025

Study contacts

Guillaume Lassailly, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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