Evaluating LivPhcD Capsules for Non-Alcoholic Fatty Liver Disease

Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects

This study is testing if LivPhcD capsules can help people with non-alcoholic fatty liver disease reduce liver fat and improve their liver health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: TCM Biotech International Corp. (Industry-sponsored)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Taipei, Not Required For This Country)
• Trial ID: NCT05930093 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of LivPhcD capsules in patients with non-alcoholic fatty liver disease (NAFLD). It aims to assess the impact of these capsules on liver fat content using Fibroscan technology. Participants will be administered varying doses of LivPhcD or a placebo to determine the optimal treatment for reducing liver fat accumulation. The study targets individuals with specific eligibility criteria, including age and liver health status.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20 to 75 with a BMI between 20 and 50 and diagnosed with early-stage NAFLD.

Not a fit: Patients with other chronic liver diseases or those on medications that induce steatosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from NAFLD, potentially improving liver health and preventing progression to more severe liver conditions.

How similar studies have performed: While there are no FDA-approved medications for NAFLD, previous studies have shown promising results with hepatoprotective agents, making this approach potentially beneficial yet still novel.

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

Where this trial is running

Taipei, Not Required For This Country

• National Taiwan University Hospital — Taipei, Not Required For This Country, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chun-Jen Liu, Ph.D

Conditions NAFLD