FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients (OBEMASLD)

June 17, 2026 updated by: Vincenza Di Stasi, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy

This single-center, prospective observational study aims to assess the accuracy of FIB-4 cut-offs in identifying liver fibrosis in obese patients attending an endocrinology outpatient clinic in Italy.

All consecutive eligible patients undergo routine blood tests and liver elastography (FibroScan) as part of clinical practice; FIB-4 values will be calculated and compared with liver stiffness measurements to evaluate the performance of FIB-4 thresholds for directing patients to FibroScan and hepatology care.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a frequent complication of metabolic syndrome and obesity and may progress to advanced fibrosis, cirrhosis and hepatocellular carcinoma.

Recent EASL-EASD-EASO guidelines recommend the use of the FIB-4 score as a first-line non-invasive tool to stratify the risk of advanced fibrosis in patients with metabolic risk factors, including those with obesity.

However, current FIB-4 cut-offs may lead to a high number of positive cases and an important burden of further liver stiffness assessment.

This study will prospectively enroll obese patients referred to the Clinical Nutrition Center for the Research and Care of Obesity and Metabolic Diseases at IRCCS "Saverio de Bellis".

During a Day Service access, patients undergo routine blood tests and FibroScan; FIB-4 is calculated using age, AST, ALT and platelet count.

Patients will be classified according to FIB-4 (≥1.3 vs <1.3), and FIB-4 performance in predicting liver fibrosis, as assessed by liver stiffness, will be evaluated using correlation analyses, Bland-Altman plots, agreement measures and ROC curves.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult obese patients (BMI ≥ 30 and ≤ 40 kg/m²), aged 18-64 years, attending the outpatient Clinical Nutrition Center for the Research and Care of Obesity and Metabolic Diseases at IRCCS "Saverio de Bellis" (Castellana Grotte, Italy). Patients are enrolled during a Day Service access in which routine blood tests and liver stiffness measurement by FibroScan are performed as part of standard clinical practice. Patients are stratified into two cohorts based on FIB-4 score: Cohort 1 (FIB-4 ≥ 1.3) and Cohort 2 (FIB-4 < 1.3). Patients with known liver diseases other than MASLD, pregnancy, or current treatment with GLP-1 receptor agonists known to affect hepatic steatosis (Semaglutide or Tirzepatide) are excluded

Description

Inclusion Criteria:

  • Obesity class I or II (body mass index, BMI ≥ 30 kg/m² and ≤ 40 kg/m²)
  • Age > 18 years and < 65 years.
  • Ability to provide written informed consent after adequate information on the study objectives.
  • Arm 1: patients with FIB-4 ≥ 1.3.
  • Arm 2: patients with FIB-4 < 1.3.

Exclusion Criteria:

  • Lack of signed informed consent.
  • Pregnancy or breastfeeding.
  • Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).
  • Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High FIB-4
Obese patients with FIB-4 ≥ 1.3 undergoing FibroScan as part of clinical practice.
Low FIB-4
Obese patients with FIB-4 < 1.3 undergoing FibroScan as part of clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosis
Time Frame: At baseline evaluation (Day Service visit)
Diagnostic accuracy (sensitivity, specificity, predictive values, ROC-AUC) of FIB-4 thresholds (e.g. 1.3) for the prediction of liver fibrosis as defined by liver stiffness measurements obtained by FibroScan.
At baseline evaluation (Day Service visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC2026-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on MASLD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe