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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT06297434
Eligibility Criteria:
Inclusion Criteria:
1. A subject aged ≥19 years to ≤75 years
2. Meeting all of the following criteria:
* Screening MRI-PDFF with ≥8% steatosis
* Screening MRE with liver stiffness ≥2.5 kPa
* ALT or AST ≤250 IU/L at screening
3. Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
4. Voluntarily provide written consent to participate in the study
Exclusion Criteria:
1. A subject who has past or current history of liver diseases
2. A subject who has the following medical or surgical history
* Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class
3. A subject who has the following concomitant diseases
* liver disease, uncontrolled hypertension, uncontrolled DM, etc.
4. A subject who has taken the following medications
* Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.
5. A subject who has taken IP of another study
6. A subject who does not agree with appropriate methods of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT06297434
Study Brief:
Protocol Section:
NCT06297434