Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
NAFLD
About this trial
This is an interventional treatment trial for NAFLD
Eligibility Criteria
Inclusion Criteria: Male or female between 20 and 75 years of age. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel. Has a body mass index (BMI) ≥20 kg/m^2 and ≤50 kg/m^2 and stable weight for the past 3 months CAP ≥ 238 db/m Fibro scan (transient elastography) F0~F3 Exclusion Criteria: Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period Type 1 diabetes mellitus. 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. 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. 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. 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 Known alcohol abuse or alcohol use disorder (>20 g/day for women; >30 g/day for men) 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 Subjects with hemoglobin A1c (HbA1c) >8.5% within 3 months before study entry Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery) Participation in any other investigational clinical trial within 30 days of entry to this protocol; History of HIV
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo
2 cap.LivPhcD/per day
4 cap.LivPhcD/per day
6 cap.LivPhcD/per day
Placebo without active ingredient
515mg/LivPhcD cap. 2 cap./per day
515mg/LivPhcD cap. 4 cap./per day, BID
515mg/LivPhcD cap. 6 cap./per day, TID