Clinical trial NCT05930093: Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Official title: Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
Lead sponsor: TCM Biotech International Corp.
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (also called NAFLD) is a disease in which excessive fat accumulates in the liver of a patient without a history of alcohol abuse. Early-stage NAFLD does not usually cause any harm but nonalcoholic steatohepatitis (NASH) can lead to serious liver damage, including fibrosis or cirrhosis. Nearly 25% of the world's population is affected by NAFLD.

There are no FDA-approved medications for the treatment of NAFLD currently and although lifestyle modifications with appropriate diet and exercise have been shown to be beneficial, this has been difficult to achieve and sustain for the majority of patients.

LivPhcD™ capsule have shown hepatoprotective effects in both animal and human data. This study aims to investigate the effects of LivPhcD™ capsule in hepatocellular lipid content using Fibroscan.


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

Primary outcomes:
measure: Reduction of Liver Fat
timeFrame: 36 weeks
Secondary outcomes:
measure: Change in liver fat at least 30% reduction
timeFrame: 24 weeks and 36 weeks
measure: Change in liver fat at least 1 stage reduction
timeFrame: 24 weeks and 36 weeks
measure: Change in liver fat
timeFrame: 24 weeks and 36 weeks
measure: Stable in liver fat
timeFrame: 24 weeks and 36 weeks
measure: Change in liver fibrosis at least 10% reduction
timeFrame: 24 weeks and 36 weeks
measure: Change in liver fibrosis at least 1 stage reduction
timeFrame: 24 weeks and 36 weeks
measure: Stable in liver fibrosis
timeFrame: 24 weeks and 36 weeks
measure: Change in liver fibrosis
timeFrame: 24 weeks and 36 weeks
measure: Change in ALT
timeFrame: 24 weeks and 36 weeks
measure: Change in AST
timeFrame: 24 weeks and 36 weeks
measure: Change in GGT
timeFrame: 24 weeks and 36 weeks
measure: Change in AP
timeFrame: 24 weeks and 36 weeks
measure: Change in Bilirubin
timeFrame: 24 weeks and 36 weeks
measure: Change in Triglyceride
timeFrame: 24 weeks and 36 weeks
measure: Change in Total Cholesterol
timeFrame: 24 weeks and 36 weeks
measure: Change in HDL-C
timeFrame: 24 weeks and 36 weeks
measure: Change in LDL-C
timeFrame: 24 weeks and 36 weeks
measure: Change in TNF-α
timeFrame: 24 weeks and 36 weeks
measure: Change in C-Reactive Protein
timeFrame: 24 weeks and 36 weeks
measure: Change in Albumin
timeFrame: 24 weeks and 36 weeks
measure: Occurrence of adverse events and serious adverse events
timeFrame: 24 weeks and 36 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Not required for this country
Study officials:
References: