Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

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

A generic screening study to establish structural and/or functional baselines of specific organs.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Fatty Liver; Obesity and Obesity-related Medical Conditions; MASLD; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Diagnostic test: Bioimpedence Vector Analysis

Detailed Description

Fatty liver disease is a common condition (25% of the population) which can lead to liver inflammation, liver scarring and even liver cancer. Clinical trials are often performed in healthy volunteers, who may have underlying fatty liver without knowledge of it. In clinical trials fatty liver can both mean volunteers have abnormal liver tests, preventing them joining the trial, as well as more likely to have a possible liver drug reaction, causing volunteers to withdraw from a clinical trial of a new drug.

The principal objective of the study is to develop a clinical scoring tool that can accurately predict fatty liver disease in study volunteers, without the need for invasive tests (such as a tissue biopsy).

We aim to recruit initially 2000 volunteers to this study, both healthy volunteers and patients with known MASLD.

Volunteers will attend the unit to undergo all assessments on one day. Once consent is given with a study research physician, bloods will be taken and body measurements made (including BMI, weight, waist circumference). A full medical history and physical examination will then be performed by the research physician.

Bioimpedance body composition analysis will then be performed on an ACUNIQ device. Finally ultrasound of the liver and fibroscan will be performed. Once all assessments are complete the study volunteer will be discharged from the unit.

Once all results are finalised, analysis will be performed on all the data to create a clinical score to predict the presence of MASLD, both with statistical and machine learning methods.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: James Rickard; Phone Number: +44 (0)20 7042 5800; Email: grants@richmondresearchinstitute.org

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 1YR
    • Recruiting
    • Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
    • Principal Investigator: Jorg Taubel, MD FFPM
    • Contact: James Rickard; Email: j.rickard@richmondpharmacology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult male or female volunteers for other clinical trials taking place at the study unit.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with MASLD; Patients with known MASLD	Diagnostic test: Bioimpedence Vector Analysis; Bioimpedence vector analysis
Healthy volunteers; Patients without any known health issues	Diagnostic test: Bioimpedence Vector Analysis; Bioimpedence vector analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of Classification Tool for Use in Clinical Trials	The success of the final classification tool (as measured by area under the receiver operator curve (AUROC). The initial measure to generate the dataset will be the presence or absence of MASLD on liver USS.	Study duration (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal LFT Range in NAFLD patients	The normal range of LFT's in patients with known NAFLD	Study duration (1 year)

Collaborators and Investigators

• Sponsor: Richmond Research Institute
• Collaborators: Richmond Pharmacology Limited
• Investigators: Principal Investigator: Jorg Taubel, MD, Richmond Pharmacology Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Fatty liver; MASLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: C19030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No