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

Study acronym: UNMASK
StatusRecruiting
PhaseNot applicable
Started2026-01-20
View on ClinicalTrials.gov ↗

Amendment history

2026-06-18
Study Identification, Study Status, Outcome Measures v1
Primary endpoint(s) modified3 entries, revised
WasFibrosis regression, MASH resolution, Steatosis response
NowChange From Baseline in Metabolic Dysfunction-Associated Steatohepatitis Resolution Index Score, Number of Participants Achieving Fibrosis Regression, Number of Participants Achieving a Steatosis Response
Study title-8 characters
UNMASK: UNveilingUnveiling the Pathobiology of Metabolic Dysfunction-associatedAssociated Steatotic Liver Disease (MASLD) for the Discovery of Novel Therapeutics and biomarKersBiomarkers
2026-06-11
Original filing
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.
Trial Details
NCT Number NCT07652151
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators: Instituto de Salud Carlos III, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Hacettepe University, Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Enrollment 450 participants
Start Date 2026-01-20
Primary Completion 2026-11 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-23