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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT04897594
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 to 75 years of age
* Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
* Presumed NASH based on clinical characteristics or prior liver biopsy
* ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
* MRI-cT1 value\> 800 ms
* Written informed consent
Exclusion Criteria:
* History or clinical evidence of chronic liver diseases other than NAFLD
* History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
* History of liver transplant, or current placement on a liver transplant list
* Weight loss of \> 5% total body weight within 3 months prior to Screening
Note: Other protocol-defined inclusion/exclusion criteria could apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04897594
Study Brief:
Protocol Section:
NCT04897594