NCT06907563

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Timeline

• Start date: 2025-04-15
• Primary completion: 2030-12-31
• Completion: 2035-12-31
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

4 sites across 4 countries: France, Germany, Italy, United Kingdom