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Clinical Trials in Italy / NCT07652151
Recruiting Not applicable

UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers

NCT07652151 · tracked via the Priya Life Science Italy tracker
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase
Not applicable
Started
2026-01-20
Last updated
2026-06-23

Condition(s) studied

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Investigational drug(s) / intervention(s)

Multimodal lifestyle intervention

Multimodal lifestyle intervention: Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks.

Study summary

Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort.

Study details include:

* Study duration will be up to 36 months including the screening period.
* Intervention will be up to 16 weeks.
* Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Metabolic disarrangements following ATPIII criteria (i.e. comorbidities such as Type 2 diabetes, central obesity, BMI≥\>25 kg/m2, hypertension, dyslipidaemia. * Written informed consent * No dietetical counsellor/weight loss higher than 10% within the prior 6 months * Age over 18 years old * Liver stiffness measurement by Fibroscan ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%. , Exclusion Criteria: * Significant alcohol intake (≥30 g/day in men and ≥20 g/day in women) * Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases) * Use of recreational drugs * Decompensated acute or chronic liver disease * Cirrhosis or transplant waitlist * Pregnancy or parenteral nutrition * No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year * Presence of other comorbidities that would impact lifestyle intervention (i. e. prosthesis) * Absence of a personal smartphone with a compatible operating system capable of supporting the Amazfit Bip 6 accelerometer app's functionalities: Android 7.0 or iOS 14.0, or later.

Primary outcome measure(s)

  • Number of Participants Achieving a Steatosis Response — From baseline to month 16
    Defined as a 30% decrease in MRI-Proton Density Fat Fraction (PDFF) and CAP assessed by Transient Elastography
  • Number of Participants Achieving Fibrosis Regression — From baseline to month 16
    \>20% reduction in liver stiffness measured by MRE.
  • Change From Baseline in Metabolic Dysfunction-Associated Steatohepatitis Resolution Index Score — From baseline to month 16
    Change from baseline to Month 16 in the Metabolic Dysfunction-Associated Steatohepatitis Resolution Index (MASH Resolution Index; MASH-RI), a composite non-invasive score developed to estimate resolution of steatohepatitis. The MASH-RI is calculated as: 0.520-0.003×baseline ALT (U/L)-0.024×(latest ALT (U/L)-baseline ALT (U/L))-0.048×baseline MRI-PDFF-2.571×(\[latest MRI-PDFF-baseline MRI-PDFF\]/baseline MRI-PDFF)-0.039×baseline AST (U/L). A MASH-RI ≥-0.67 rules in MASH resolution, and a MASH-RI of ≤-2.67 rules out a resolution.

Trial sites (3)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit Roma Italy Not Yet Recruiting
Hospital Universitario Virgen del Rocío de Sevilla Seville Spain Recruiting
Hacettepe University Ankara Turkey (Türkiye) Not Yet Recruiting

More Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials in Italy

Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652151 on ClinicalTrials.gov ↗ ← All trials in Italy