NCT07652151 UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers
| NCT ID | NCT07652151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Condition | MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2026-01-20 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT07652151 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07652151 currently recruiting?
Yes, NCT07652151 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fundación Pública Andaluza para la gestión de la Investigación en Sevilla to inquire about joining.
Where is the NCT07652151 trial being conducted?
This trial is being conducted at Roma, Italy, Seville, Spain, Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07652151 clinical trial?
NCT07652151 is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. The trial plans to enroll 450 participants.