Status:
RECRUITING
Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
Lead Sponsor:
Richmond Research Institute
Collaborating Sponsors:
Richmond Pharmacology Limited
Conditions:
Healthy
Fatty Liver
Eligibility:
All Genders
18-80 years
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,...
Eligibility Criteria
Inclusion
- 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:
- 1\. With a known history of MASLD as evidenced either of:
- GP diagnosis on HCF
- Documented Fibroscan or liver US demonstrating MASLD
Exclusion
- 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
Key Trial Info
Start Date :
September 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04873258
Start Date
September 27 2019
End Date
December 31 2027
Last Update
July 23 2025
Active Locations (1)
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1
Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
London, London, United Kingdom, SE1 1YR