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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05930093
Eligibility Criteria:
Inclusion Criteria:
1. Male or female between 20 and 75 years of age.
2. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.
3. Has a body mass index (BMI) ≥20 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months
4. CAP ≥ 238 db/m
5. Fibro scan (transient elastography) F0\~F3
Exclusion Criteria:
1. Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period
2. Type 1 diabetes mellitus.
3. History of other causes of chronic liver disease \[autoimmune, primary biliary cirrhosis, HBV (HBsAg positive) and HCV, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc.
4. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine.
5. Use of vitamin E (doses ≥800 IU/dy) or pioglitazone or SGLT2 inhibitor or GLP-1 agonists any FDA-approved drug for NASH to be approved during the study.
6. Has significant systemic or major illnesses other than liver disease, ex: recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, serious COPD, renal failure and need hemodialysis, stroke, transient ischemic attack, or organ transplantation
7. Known alcohol abuse or alcohol use disorder (\>20 g/day for women; \>30 g/day for men)
8. Has the abnormal data including: fasting TG \>400 mg/dL ; ALT or GGT\>5.0 x ULN；Bilirubin \>2 x ULN，unless due to an alternative etiology such as Gilbert's syndrome; INR ≥1.3; Albumin \< LLN; Platelet \<0.95x LLN
9. Subjects with hemoglobin A1c (HbA1c) \>8.5% within 3 months before study entry
10. Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery)
11. Participation in any other investigational clinical trial within 30 days of entry to this protocol(including drugs, medical devices, novel medical technologies, food, and lifestyle interventions affecting diet, exercise, and circadian rhythm investigational clinical trial.);
12. History of HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT05930093
Study Brief:
Protocol Section:
NCT05930093