Non-invasive tool to predict fatty liver disease

Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Volunteers on Clinical Trials Utilising Machine-learning and Bioimpedance Vector Analysis

This study is testing a new, non-invasive tool to see if it can help identify fatty liver disease in healthy people and those already diagnosed with it.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Richmond Pharmacology Limited (industry)
• Locations: 1 site (London, London)
• Trial ID: NCT04873258 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop a clinical scoring tool that can accurately predict metabolic dysfunction-associated steatotic liver disease (MASLD) in volunteers without the need for invasive tests like biopsies. The study will recruit 2000 participants, including both healthy individuals and those with known MASLD, who will undergo a series of assessments in a single visit. These assessments include blood tests, body measurements, bioimpedance analysis, and liver imaging techniques. The goal is to establish a reliable screening method that can identify fatty liver disease early, potentially improving patient outcomes in clinical settings.

Who should consider this trial

Good fit: Ideal candidates include healthy volunteers aged 18-80 and patients with a known history of MASLD.

Not a fit: Patients with known alcoholic liver disease or significant previous liver pathology may not benefit from this study.

Why it matters

Potential benefit: If successful, this tool could enable earlier detection and management of fatty liver disease, reducing the risk of severe liver complications.

How similar studies have performed: Other studies have explored non-invasive methods for liver disease screening, showing promise, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
2. Willingness and ability to provide written, personally signed, and dated informed consent, in accordance with the latest ICH Good Clinical Practice (GCP) Guidelines and applicable regulations.
3. An understanding, ability and willingness to fully comply with project procedures and restrictions.

For PART B only:

1\. With a known history of MASLD as evidenced either of:

1. GP diagnosis on HCF
2. Documented Fibroscan or liver US demonstrating MASLD

Exclusion Criteria:

1. Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)
2. Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)
3. Alcohol consumption \>30 units per week
4. An Implanted cardiac devices

Where this trial is running

London, London

• Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge — London, London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Jorg Taubel, MD — Richmond Pharmacology Limited
• Study coordinator: James Rickard

Conditions: Healthy, Fatty Liver, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Obesity and Obesity-related Medical Conditions, Fatty liver