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

NCT ID: NCT04494360

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

830 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-07

Study Completion Date

2022-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Participants

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

No intervention

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Centers of America, LLC

Hollywood, Florida, United States

Site Status

PRA Health Sciences

Lenexa, Kansas, United States

Site Status

Endeavor Clinical Trials, LLC

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NOPRODNAS0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108830

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Genetic Study of Sitosterolemia
NCT00004481 COMPLETED