Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)

The rational to conduct the LOVE study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. At current limited data on liver-specific and overall outcome in patients with MASLD, MetALD and ALD are available. Liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. To overcome the limitations of liver biopsy and use validated non-invasive tests (NITs) to predict outcomes, the LOVE study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. The overarching goal is to qualify a NIT for patient identification and preventive measures in the regulatory context.

NCT Number	NCT06907563
Lead Sponsor	Universität des Saarlandes Collaborators: Universitatsmedizin Mainz - 1. Medizinische Klinik, Newcastle University, Barcelona Institute for Global Health, Odense University Hospital, Hospital Clinic of Barcelona, Assistance Publique - Hôpitaux de Paris, University of Turin, Italy
Conditions	Steatotic Liver Disease, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Steatotic Liver Disease of Mixed Origin (MetALD), ALD - Alcoholic Liver Disease
Enrollment	30,000 participants
Start Date	2025-04-15
Primary Completion	2030-12-31 (estimated)
Study Completion	2035-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-02