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

NCT04494360 | Completed

• 2 other identifiers: CR108830NOPRODNAS0001
• Study Type: observational
• Target: 830
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Liver Fibrosis Estimated with Fibroscan

  Up to 8 weeks

• Hepatic Fat Fraction

  Up to 8 weeks

Study Arms (1)

Healthy Participants

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

Other: No intervention

Interventions

No intervention OTHER

No investigational medicinal product will be administered as a part of this study.

Healthy Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78240, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: August 7, 2020
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)