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
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedStudy Start
First participant enrolled
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 10, 2025
April 1, 2025
2.1 years
May 28, 2023
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (21)
Change in liver fat at least 30% reduction
24 weeks and 36 weeks
Change in liver fat at least 1 stage reduction
24 weeks and 36 weeks
Change in liver fat
24 weeks and 36 weeks
Stable in liver fat
24 weeks and 36 weeks
Change in liver fibrosis at least 10% reduction
24 weeks and 36 weeks
- +16 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo without active ingredient
2 cap.LivPhcD/per day
ACTIVE COMPARATOR515mg/LivPhcD cap. 2 cap./per day
4 cap.LivPhcD/per day
ACTIVE COMPARATOR515mg/LivPhcD cap. 4 cap./per day, BID
6 cap.LivPhcD/per day
ACTIVE COMPARATOR515mg/LivPhcD cap. 6 cap./per day, TID
Interventions
2 caps. LivPhcD cap. after meal, once a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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(including drugs, medical devices, novel medical technologies, food, and lifestyle interventions affecting diet, exercise, and circadian rhythm investigational clinical trial.);
- History of HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Not Required For This Country, 221, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2023
First Posted
July 5, 2023
Study Start
December 7, 2023
Primary Completion
January 1, 2026
Study Completion
May 1, 2026
Last Updated
April 10, 2025
Record last verified: 2025-04