Steatotic Liver DiseaseLOVENCT06907563
Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)
An observational study of Steatotic Liver Disease and MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), run by Universität des Saarlandes at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatotic Liver Disease, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Steatotic Liver Disease of Mixed Origin (MetALD)
- How many people
- 30,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 Apr 2025to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: European SLD register (historically EPOS, LITMUS); 18 european countries. https://pubmed.ncbi.nlm.nih.gov/33045403/
Who may be able to join
- Previous Informed consent for cohort studies
- > 18 years of age
- Diagnosis of SLD (MASLD, MetALD, ALD)
Who cannot join
- No consent for previous cohort studies
- < 18 years of age
- No Diagnosis of SLD (MASLD, MetALD, ALD)
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
France1 site
Hôpital de la Pitié Salpêtrière
Paris, 75013
Scientific Affaires Officer, PhD, MPH, 0033, j.medvedovic@ihuican.org
Germany1 site
University Medical Center Saarland, Department of Internal Medicine II
Homburg, Saarland, 66421
Italy1 site
Division of Gastroenterology, Department of Medical Sciences, University of Turin
Turin
Division of Gastroenterology, Department of Medical Sciences, 0039 11 6333272, elisabetta.bugianesi@unito.it
United Kingdom1 site
Translational & Clinical Research Institute Faculty of Medical Sciences
Newcastle upon Tyne, NE2 4HH
Kristy Wonders, +44, SLD.Registry@newcastle.ac.uk
About this 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.
- 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
- Keywords
- MASH, SLD, NITs, MASLD, ALD, MetALD, Metabolism, Liver
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| European SLD Registry | The EU-SLD registry comprises patients from 18 european countries and a study cohort of n=8.984 with most recent cases recruited in the prospective LITMUS cohort study. Now followed up as part of the LOVE Study in the EU-LIVERAIM project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major-adverse liver outcomes (MALO)
Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices.
Measured: 5 years follow-up time
All-cause mortality
Death during the follow-up period due to any cause
Measured: 5 years follow-up time
Secondary outcomes (4)
Health-related quality of life (HRQL)
To measure the impact on the health-related quality of life in patients during the natural history of the disease.
Measured: 5 years
Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes
Measured: 5 years
Major adverse cardiac events (MACE)
Measured: 5 years
Development of relevant clinical outcomes
Incidence of cancer, chronic kidney disease, neurodegenerative disease, dementia, and depression
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907563
- Sponsor's protocol ID
- LOVE study
- Acronym
- LOVE
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up to Determine Outcome in Liver Disease (LOVE Study)
- ClinicalTrials.gov ID
- NCT06907563
- Acronym / sponsor ID
- LOVE / LOVE study
- 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
- Keywords
- MASH, SLD, NITs, MASLD, ALD, MetALD, Metabolism, Liver
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- 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
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| European SLD Registry | – | –The EU-SLD registry comprises patients from 18 european countries and a study cohort of n=8.984 with most recent cases recruited in the prospective LITMUS cohort study. Now followed up as part of the LOVE Study in the EU-LIVERAIM project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- European SLD register (historically EPOS, LITMUS); 18 european countries. https://pubmed.ncbi.nlm.nih.gov/33045403/
Key inclusion criteria (3 listed)
- Previous Informed consent for cohort studies
- > 18 years of age
- Diagnosis of SLD (MASLD, MetALD, ALD)
Key exclusion criteria (3 listed)
- No consent for previous cohort studies
- < 18 years of age
- No Diagnosis of SLD (MASLD, MetALD, ALD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major-adverse liver outcomes (MALO)
Time frame: 5 years follow-up time
Development of cirrhosis. Hepatic decompensation: ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, portal hypertension, varices.
All-cause mortality
Time frame: 5 years follow-up time
Death during the follow-up period due to any cause
4 secondary outcomes
Health-related quality of life (HRQL)
Time frame: 5 years
Assess prognostic biomarkers and develop a novel tool to integrate them into a digital tool to predict outcomes
Time frame: 5 years
Major adverse cardiac events (MACE)
Time frame: 5 years
Development of relevant clinical outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatotic Liver Disease and MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), run by Universität des Saarlandes at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jörn M. Schattenberg, MD (+49684116 ext. 15027, gastroenterologie@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major-adverse liver outcomes (MALO) (time frame: 5 years follow-up time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.