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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT04282005
Eligibility Criteria:
Inclusion Criteria:
• BMI greater than 35 kg/m2 (or \>32.5. kg/m2 for patients of South Asian, Caribbean or Black ethnicities) with raised alanine transaminase (ALT), aspartate transaminase (AST) and a FibroScan® score \> 7.9 (indicating presence of NAFLD and high likelihood of NASH).
Exclusion Criteria:
* other causes of liver disease such as viral, alcoholic (alcohol consumption \>20 g/day for women or \>30 g/day for men),
* auto-immune disease
* use of certain medications that may interfere with outcome measures (i.e. corticosteroids, insulin and glycoprotein-1 (GLP-1) analogues).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04282005
Study Brief:
Protocol Section:
NCT04282005