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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NAFLD
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: 2 cap.LivPhcD/per day; Dietary supplement: 4 cap.LivPhcD/per day; Dietary supplement: 6 cap.LivPhcD/per day

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Jen Liu, Ph.D; Phone Number: 67503 +886-2-23123456; Email: cjliu@ntu.edu.tw
• Study Contact Backup: Name: Wen-Chuan Huang, Master; Phone Number: 600 +886-2-26972628; Email: lillian@tcmbio.com

Study Locations

• Taiwan
  • Not Required For This Country
    • Taipei City, Not Required For This Country, Taiwan, 221
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Chun-Jen Liu, Ph. D; Phone Number: +886-2-2312-3456; Email: cjliu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
12. History of HIV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo without active ingredient	Dietary supplement: Placebo; Placebo matching LivPhcD cap.
Active Comparator: 2 cap.LivPhcD/per day; 515mg/LivPhcD cap. 2 cap./per day	Dietary supplement: 2 cap.LivPhcD/per day; 2 caps. LivPhcD cap. after meal, once a day
Active Comparator: 4 cap.LivPhcD/per day; 515mg/LivPhcD cap. 4 cap./per day, BID	Dietary supplement: 4 cap.LivPhcD/per day; 4 caps. LivPhcD cap. after meal, BID
Active Comparator: 6 cap.LivPhcD/per day; 515mg/LivPhcD cap. 6 cap./per day, TID	Dietary supplement: 6 cap.LivPhcD/per day; 6 caps. LivPhcD cap. after meal, TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Liver Fat	Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter)	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in liver fat at least 30% reduction	Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP	24 weeks and 36 weeks
Change in liver fat at least 1 stage reduction	Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP	24 weeks and 36 weeks
Change in liver fat	Between group difference in mean change of liver fat by CAP	24 weeks and 36 weeks
Stable in liver fat	Between group difference in the proportion of patients with stable of baseline of liver fat by CAP	24 weeks and 36 weeks
Change in liver fibrosis at least 10% reduction	Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan	24 weeks and 36 weeks
Change in liver fibrosis at least 1 stage reduction	Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan	24 weeks and 36 weeks
Stable in liver fibrosis	Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan	24 weeks and 36 weeks
Change in liver fibrosis	Between group difference in mean change of FIB-4	24 weeks and 36 weeks
Change in ALT	Between group difference in mean change or in the proportion of patients of ALT	24 weeks and 36 weeks
Change in AST	Between group difference in mean change or in the proportion of patients of AST	24 weeks and 36 weeks
Change in GGT	Between group difference in mean change or in the proportion of patients of GGT	24 weeks and 36 weeks
Change in AP	Between group difference in mean change or in the proportion of patients of AP	24 weeks and 36 weeks
Change in Bilirubin	Between group difference in mean change or in the proportion of patients of Bilirubin	24 weeks and 36 weeks
Change in Triglyceride	Between group difference in mean change or in the proportion of patients of Triglyceride	24 weeks and 36 weeks
Change in Total Cholesterol	Between group difference in mean change or in the proportion of patients of Total Cholesterol	24 weeks and 36 weeks
Change in HDL-C	Between group difference in mean change or in the proportion of patients of HDL-C	24 weeks and 36 weeks
Change in LDL-C	Between group difference in mean change or in the proportion of patients of LDL-C	24 weeks and 36 weeks
Change in TNF-α	Between group difference in mean change or in the proportion of patients of TNF-α	24 weeks and 36 weeks
Change in C-Reactive Protein	Between group difference in mean change or in the proportion of patients of C-Reactive Protein	24 weeks and 36 weeks
Change in Albumin	Between group difference in mean change or in the proportion of patients of Albumin	24 weeks and 36 weeks
Occurrence of adverse events and serious adverse events	Between group difference in the occurrence of adverse events and serious adverse events.	24 weeks and 36 weeks

Collaborators and Investigators

• Sponsor: TCM Biotech International Corp.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: LivPhcD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No