HealthyMASLDNCT04873258
Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
An observational study of Healthy and Fatty Liver, run by Richmond Research Institute at 1 site in United Kingdom.
Trial summary
A generic screening study to establish structural and/or functional baselines of specific organs. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Fatty Liver, MASLD
- What is being tested?
- Bioimpedence Vector Analysis
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Sep 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult male or female volunteers for other clinical trials taking place at the study unit.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
London, London, SE1 1YR
James Rickard, j.rickard@richmondpharmacology.com
Jorg Taubel, MD FFPM
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Fatty Liver, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Obesity and Obesity-related Medical Conditions
- Being tested
- Bioimpedence Vector Analysis
- Keywords
- Fatty liver, MASLD
- Medical subject headings
- Fatty Liver, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedence Vector AnalysisDiagnostic test
Bioimpedence vector analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with MASLD | Patients with known MASLD Receives: Diagnostic Test: Bioimpedence Vector Analysis | |
| Healthy volunteers | Patients without any known health issues Receives: Diagnostic Test: Bioimpedence Vector Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study duration (1 year)
Secondary outcomes (1)
Normal LFT Range in NAFLD patients
The normal range of LFT's in patients with known NAFLD
Measured: Study duration (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start27 Sep 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richmond Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Jorg Taubel, MD, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873258
- Sponsor's protocol ID
- C19030
- Acronym
- MASLD
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04873258
- Acronym / sponsor ID
- MASLD / C19030
- Conditions
- Healthy, Fatty Liver, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Obesity and Obesity-related Medical Conditions
- Keywords
- Fatty liver, MASLD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Richmond Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MASLD | – | Diagnostic Test: Bioimpedence Vector AnalysisPatients with known MASLD |
| Healthy volunteers | – | Diagnostic Test: Bioimpedence Vector AnalysisPatients without any known health issues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male or female volunteers for other clinical trials taking place at the study unit.
Key inclusion criteria (7 listed)
- 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.
- GP diagnosis on HCF
- Documented Fibroscan or liver US demonstrating MASLD
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioimpedence Vector AnalysisBioimpedence vector analysis | Diagnostic test | Healthy volunteers, Patients with MASLD |
Primary outcome
Establishment of Classification Tool for Use in Clinical Trials
Time frame: 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.
1 secondary outcome
Normal LFT Range in NAFLD patients
Time frame: Study duration (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorg Taubel, MD principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Fatty Liver, run by Richmond Research Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Rickard (+44 (0)20 7042 5800, grants@richmondresearchinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of Classification Tool for Use in Clinical Trials (time frame: Study duration (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.