HealthyNCT04494360
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD
An observational study of Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.
Trial summary
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 830 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Aug 2020to 10 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants, who are known to have, or are likely to have, NAFLD.
Who may be able to join
- No clinically significant abnormality based on medical history, physical exam, and 12-lead electrocardiogram (ECG) collected during Visit 1
- Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or b.) Permanently sterile
- Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of genetic variants associated with NAFLD
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Who cannot join
- History or presence of drug abuse within the 2 years prior to Visit 1
- Excessive use of alcohol within 2 years prior to the study
- Body mass index greater than (>) 40 kilogram per meter square (kg/m^2)
- Evidence of other active (acute or chronic) liver disease other than NAFLD/ Nonalcoholic steatohepatitis (NASH)
- History of bariatric surgery or planning to undergo bariatric surgery within the next year
- Inability to undergo magnetic resonance imaging (MRI)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Centers of America, LLC
Hollywood, Florida, 33024
PRA Health Sciences
Lenexa, Kansas, 66219
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240
About this study
Official title: Study for the Identification of Participants With Liver Steatosis Who Carry Genetic Variants Associated With Nonalcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
- Conditions
- Healthy
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No investigational medicinal product will be administered as a part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Genetic Variants Associated with NAFLD
Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated.
Measured: Up to 8 weeks
Liver Fat Content Estimated with Fibroscan
Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (>=) 310 decibels per minute (dB/m) (that is, liver fat >= 10 percent [%]) will be estimated.
Measured: Up to 8 weeks
Secondary outcomes (2)
Liver Fibrosis Estimated with Fibroscan
Fibroscan will be conducted to obtain liver stiffness measurement to estimate liver fibrosis. Number of participants with absent, low or moderate fibrosis (that is, less than or equal to (<=) 9 kilopascals [kPa]) will be estimated.
Measured: Up to 8 weeks
Hepatic Fat Fraction
The liver fat fraction will be obtained by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to estimate the inter-participant variability in liver fat measurement.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start7 Aug 2020
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494360
- Sponsor's protocol ID
- CR108830
- Other IDs
- NOPRODNAS0001
- Status last verified
- Mar 2025
- First submitted
- 28 Jul 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Identification of Participants With Liver Steatosis Who Carry Genetic Variants Associated With Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT04494360
- Acronym / sponsor ID
- CR108830
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 31 Jul 2020 (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.
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | Other: No interventionHealthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants, who are known to have, or are likely to have, NAFLD.
Key inclusion criteria (4 listed)
- No clinically significant abnormality based on medical history, physical exam, and 12-lead electrocardiogram (ECG) collected during Visit 1
- Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or b.) Permanently sterile
- Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of genetic variants associated with NAFLD
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Key exclusion criteria (6 listed)
- History or presence of drug abuse within the 2 years prior to Visit 1
- Excessive use of alcohol within 2 years prior to the study
- Body mass index greater than (>) 40 kilogram per meter square (kg/m^2)
- Evidence of other active (acute or chronic) liver disease other than NAFLD/ Nonalcoholic steatohepatitis (NASH)
- History of bariatric surgery or planning to undergo bariatric surgery within the next year
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 |
|---|---|---|
| No interventionNo investigational medicinal product will be administered as a part of this study. | Other | Healthy Participants |
Primary outcome
Prevalence of Genetic Variants Associated with NAFLD
Time frame: Up to 8 weeks
Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated.
Liver Fat Content Estimated with Fibroscan
Time frame: Up to 8 weeks
Fibroscan will be performed to obtain the controlled attenuation parameter (CAP) score to estimate liver fat content. Number of participants with a CAP score greater or equal to (>=) 310 decibels per minute (dB/m) (that is, liver fat >= 10 percent [%]) will be estimated.
2 secondary outcomes
Liver Fibrosis Estimated with Fibroscan
Time frame: Up to 8 weeks
Hepatic Fat Fraction
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Genetic Variants Associated with NAFLD (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. 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 30 Mar 2025.