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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT04383951
Eligibility Criteria:
Inclusion Criteria:
1. NASH cirrhosis (criteria in Appendix 1) with obesity (BMI \>30 kg/m2).
2. Age 18 and greater
Exclusion Criteria:
1. Actively participation in investigational drug treatment for non-alcoholic fatty liver disease
2. Currently taking medications for weight loss or have joined a supervised weight loss program prior to enrollment
3. Have hepatocellular carcinoma and are undergoing therapy
4. Women who become pregnant or plan to become pregnant prior to the study date; female subjects who become pregnant during the study will be withdrawn from the study
5. Pacemaker or implantable cardioverter devices
6. History of hepatic surgery
7. Current significant alcohol consumption, defined as more than 20 grams per day in females or 30 grams per day in males
8. Presence of ascites or hepatic encephalopathy
9. Symptomatic gastroparesis
10. Uncontrolled diabetes, as defined by a HgbA1C \>11%
11. Uncontrolled congestive heart failure
12. Active infections
13. Child Turcotte Pugh score \> 6
14. MELD score \>12
15. Unwilling to undergo an MRI or have contraindications to an MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04383951
Study Brief:
Protocol Section:
NCT04383951