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

NCT04873258 | Recruiting

• 1 other identifier: C19030
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Fatty liver; MASLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Normal LFT Range in NAFLD patients

  Study duration (1 year)

Study Arms (2)

Patients with MASLD

Patients with known MASLD

Diagnostic Test: Bioimpedence Vector Analysis

Healthy volunteers

Patients without any known health issues

Diagnostic Test: Bioimpedence Vector Analysis

Interventions

Bioimpedence Vector Analysis DIAGNOSTIC_TEST

Bioimpedence vector analysis

Healthy volunteers; Patients with MASLD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
• 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.
• An understanding, ability and willingness to fully comply with project procedures and restrictions.
• For PART B only:
• \. With a known history of MASLD as evidenced either of:
• GP diagnosis on HCF
• Documented Fibroscan or liver US demonstrating MASLD

You may not qualify if:

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

Sponsors & Collaborators

• Richmond Research Institute: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge

London, London, SE1 1YR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fatty Liver; Obesity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorg Taubel, MD

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Rickard

CONTACT

+44 (0)20 7042 5800; grants@richmondresearchinstitute.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 5, 2021
• Study Start: September 27, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)