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

Starting soon

Conditions studied: MASLD

In brief

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.

Key facts

Study ID

NCT07663188

Run by

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

People needed

400

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Full record on ClinicalTrials.gov

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