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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05118360
Eligibility Criteria:
Key Inclusion Criteria:
* Presence of ≥ 8% liver fat content on screening MRI-PDFF.
* Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.
* Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.
Key Exclusion Criteria:
* Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.
* Evidence of other causes of chronic liver disease.
* Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.
* Any contraindications to a MRI scan.
* Treatment with vitamin E (unless stable dose of \< 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.
* Known history of alcohol or other substance abuse within the last year or at any time during the study.
* Use of any investigational drug within 6 months of MRI-PDFF and/or liver biopsy.
* Known positivity for antibody to Human Immunodeficiency Virus (HIV).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05118360
Study Brief:
Protocol Section:
NCT05118360