Status:
COMPLETED
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT04494360
Start Date
August 7 2020
End Date
October 10 2022
Last Update
March 30 2025
Active Locations (3)
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1
Research Centers of America, LLC
Hollywood, Florida, United States, 33024
2
PRA Health Sciences
Lenexa, Kansas, United States, 66219
3
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78240