NCT04494360CompletedNot Applicable
Study for the Identification of Participants With Liver Steatosis Who Carry Genetic Variants Associated With Nonalcoholic Fatty Liver Disease (NAFLD)
Janssen Research & Development, LLC3 sites in 1 country830 target enrollmentStarted: August 7, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 830
- Locations
- 3
- Primary Endpoint
- Prevalence of Genetic Variants Associated with NAFLD
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Liver Fibrosis Estimated with Fibroscan(Up to 8 weeks)
- Hepatic Fat Fraction(Up to 8 weeks)
Investigators
Study Sites (3)
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