Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Healthy

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04494360

CR108830

NOPRODNAS0001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 830 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

830 participants in 1 patient group

Healthy Participants

Description:

Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study.

Treatment:

Other: No intervention