Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects

Launched by TCM BIOTECH INTERNATIONAL CORP. · Jun 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LivPhcD™ capsules for people with non-alcoholic fatty liver disease (NAFLD). NAFLD occurs when too much fat builds up in the liver without any history of alcohol abuse, and while many people with early-stage NAFLD may not experience serious problems, it can lead to more severe liver issues over time. Currently, there are no approved medications specifically for NAFLD, and lifestyle changes like diet and exercise can be challenging for many patients. This study aims to see how effective and safe LivPhcD™ capsules are in reducing fat in the liver.

To participate in the trial, individuals must be between 20 and 75 years old, have a stable weight, and meet certain health criteria related to their liver condition. Participants will undergo tests to measure liver fat and are expected to follow the study guidelines. It’s important to note that certain individuals, such as those with specific types of liver disease, pregnant women, or those taking certain medications, will not be eligible to join. This trial offers a chance to help researchers learn more about potential new treatments for NAFLD, which could benefit many people affected by this condition.

Gender

ALL

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