Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT04342793
Eligibility Criteria:
Inclusion Criteria:
* Men or women ages 19 and over, under 75 years of age
* Patients diagnosed with NAFLD on abdominal ultrasonography and MRI
* Patients show presence of hepatic fat fraction as defined by ≥ 8% on MRI-PDFF and liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening
Exclusion Criteria:
* Any subject with current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 2 year prior to screening will be excluded
* Chronic liver disease (including hemochromatosis, liver cancer, autoimmune liver disease, viral hepatitis A, B, alcoholic liver disease
* Uncontrolled diabetes mellitus as defined by a HbA1c ≥ 9.0％ at Screening
* Patients who are allergic or hypersensitive to the drug or its constituents
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT04342793
Study Brief:
Protocol Section:
NCT04342793