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

Study for the Identification of Participants With Liver Steatosis Who Carry Genetic Variants Associated With Nonalcoholic Fatty Liver Disease (NAFLD)

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 830

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America, LLC
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences
  • Texas
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants, who are known to have, or are likely to have, NAFLD.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Participants; Healthy participants (men and women) who have, or are likely to have, NAFLD will be enrolled in the study.	Other: No intervention; No investigational medicinal product will be administered as a part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Genetic Variants Associated with NAFLD	Genotyping for known mutations associated with NAFLD will be conducted and the prevalence in the overall population enrolled will be calculated.	Up to 8 weeks
Liver Fat Content Estimated with Fibroscan	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.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Fibrosis Estimated with Fibroscan	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.	Up to 8 weeks
Hepatic Fat Fraction	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.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR108830; NOPRODNAS0001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No