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 enrollmentAugust 7, 2020

ConditionsHealthy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: Janssen Research & Development, LLC
Enrollment: 830
Locations: 3
Primary Endpoint: Prevalence of Genetic Variants Associated with NAFLD
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

August 7, 2020

End Date

October 10, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

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.