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

Recruiting

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

• Registration Number: NCT04873258
• Lead Sponsor: Richmond Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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:

2. GP diagnosis on HCF

3. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of Classification Tool for Use in Clinical Trials	Study duration (1 year)	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.

Secondary Outcome Measures

Name	Time	Method
Normal LFT Range in NAFLD patients	Study duration (1 year)	The normal range of LFT's in patients with known NAFLD

Trial Locations

Locations (1)

Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge; 🇬🇧 London, United Kingdom