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OpenTrials
Completed

NCT Number: NCT04494360

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Centers of America, LLC, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Prevalence of Genetic Variants Associated with NAFLD

    Time frame: 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.

  2. Liver Fat Content Estimated with Fibroscan

    Time frame: 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 outcomes

  1. Liver Fibrosis Estimated with Fibroscan

    Time frame: 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.

  2. Hepatic Fat Fraction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2020
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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