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

Completed

• Conditions: Healthy
• Interventions: Other: No intervention

• Registration Number: NCT04494360
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2020-08-07
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 830

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Participants	No intervention	Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study.

Primary Outcome Measures

Name	Time	Method
Prevalence of Genetic Variants Associated with NAFLD	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	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 Outcome Measures

Name	Time	Method
Liver Fibrosis Estimated with Fibroscan	Up to 8 weeks	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.
Hepatic Fat Fraction	Up to 8 weeks	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.

Trial Locations

Locations (3)

PRA Health Sciences; 🇺🇸 Lenexa, Kansas, United States

Research Centers of America, LLC; 🇺🇸 Hollywood, Florida, United States

Endeavor Clinical Trials, LLC; 🇺🇸 San Antonio, Texas, United States