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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494360
• Other study ID #: CR108830
• Secondary ID: NOPRODNAS0001
• Status: Completed
• Start date: August 7, 2020
• Est. completion date: October 10, 2022

Study information

• Verified date: February 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• No intervention
No investigational medicinal product will be administered as a part of this study.

Locations

Country	Name	City	State
United States	Research Centers of America, LLC	Hollywood	Florida
United States	PRA Health Sciences	Lenexa	Kansas
United States	Endeavor Clinical Trials, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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