NCT07663188Not yet recruiting
FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients
Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 17 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07663188
What you commit to
- Study type: Observational
- Planned participants: 400
- From Sept 2026 to the primary completion date, Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).
Other illness
- Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).
Other
- Lack of signed informed consent.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.