Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

• Sponsor: Golden Biotechnology Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02719028
• Collaborator: (none)
• Enrollment: 120
• Locations: 6
• Arms: 4
• Duration (Months): 35
• Patients Per Site: 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and fatty liver.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias	Drug: Antroquinonol; Drug: placebo	Phase 2

Detailed Description

The primary efficacy objective is to demonstrate the reduction of triglyceride (TG) by Antroquinonol, in comparison with placebo, after 12 weeks of treatment in patients with hypercholesterolemia and hyperlipidemia. Secondary objectives include the evaluation of the effects of Antroquinonol in comparison with placebo on other lipid parameters after 12 weeks of treatment and the effects of Antroquinonol on left ventricular diastolic function, arterial stiffness and fatty liver. The safety and tolerability of Antroquinonol will be monitored as well.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Sep 27, 2018
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.	Drug: placebo; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
Experimental: Antroquinonol 50 mg PO Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.	Drug: Antroquinonol; Antroquinonol will be provided as capsules of 50 mg; Other Names: Hocena 50mg ; Drug: placebo; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
Experimental: Antroquinonol 100 mg PO Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.	Drug: Antroquinonol; Antroquinonol will be provided as capsules of 50 mg; Other Names: Hocena 50mg ; Drug: placebo; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
Experimental: Antroquinonol 150 mg PO Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg or Placebo) 3 capsules once a day.	Drug: Antroquinonol; Antroquinonol will be provided as capsules of 50 mg; Other Names: Hocena 50mg

Outcome Measures

Primary Outcome Measures

1. TG Change (mg/dL ) [12 weeks]

   value at 12 weeks minus value at baseline

Secondary Outcome Measures

1. LDL& HDL (mg/dL) [12 weeks]

   value at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.

2. Non-invasive Arterial Stiffness Measurement [12 weeks]

   To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.

3. Fatty Liver [12 weeks]

   To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adults of either sex 30 to 75 years of age, inclusive, with a diagnosis of nonfamilial hypercholesterolemia or mixed hyperlipidemia as one of the following:

• TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL

• TG between 150 mg/dL and 500 mg/dL and LDL-C > 130 mg/dL);

1. Subject must be free of any clinically significant disease, other than nonfamilial hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations;

2. A wash-out period of 2 weeks will be applied to patients prior treated with lipid-lowering medication;

3. Subject must be willing to adhere to protocol requirements, and provide written informed consent;

4. Female of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Exclusion Criteria:

1. Patients with secondary dyslipidemia caused by diabetes mellitus, hypothyroidism, obstructive liver disease, chronic renal failure or drugs which can increase LDL-C level (e.g. retinoids, cyclosporine A and phenothiazines) or decrease HDL-C level (e.g. progestins, androgens, β-blockers, probucol and anabolic steroid)

2. Patients with lifestyle that may interfere treatment efficacy, such as alcoholism or drinking habits more than 3 times per week, late dinner, late night supper, frequent oversea business traveler, frequent social gathering, and patients who cannot anticipate a diet control and lifestyle changes;

3. Patients with diabetes or history of coronary artery disease (has had myocardial infarction, cardiac intervention, cerebrovascular accident/stroke or transient ischemic attack less than 6 months prior to Visit 1);

4. Patients with hypertension that is uncontrolled defined as 2 consecutive measurements of sitting blood pressure of systolic >140 mmHg or diastolic > 90 mmHg at Visit 1;

5. Patient has a known hypersensitivity to Antroquinonol or related compounds;

6. Patient with uncontrolled intercurrent illness including, but not limited to, acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require IV therapy), right heart failure due to severe pulmonary disease, diagnosed peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to visit 1, or psychiatric illness/social situations that would limit compliance with study requirements;

7. Patients with a history of heart transplant or who are on a transplant list or with left ventricular assistance device (LVAD device);

8. Patients with documented ventricular arrhythmia with syncopal episodes within the past 3 months prior to visit 1 that remained untreated;

9. Patients with confirmed severe primary pulmonary, renal (eGFR<30 ml/min/1.73 m2) or hepatic (Child-Pugh B/C classification) disease;

10. Patients who can't stop current lipid lowering drug treatments based on investigator's judgement;

11. Patients with any malignancy, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin or carcinoma in situ of the cervix;

12. Female patient during pregnancy, lactation or breastfeeding;

13. Patient has any other life-threatening complications;

14. Patient who is considered unreliable as to medication compliance or adherence to scheduled appointments, or inappropriate for inclusion determined by the investigators;

15. Any other reasons addressed by the investigators.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital, Linkou branch	New Taipei City		Taiwan
2	Far Eastern Memorial Hospital	New Taipei city		Taiwan
3	China Medical University Hospital	Taichung		Taiwan
4	National Cheng Kung University Hospital	Tainan		Taiwan
5	National Taiwan University Hospital	Taipei		Taiwan
6	Taipei Veterans General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Golden Biotechnology Corporation

Investigators

• Principal Investigator: Fu-Tien Chiang, M.D., National Taiwan University Hopspital

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 9, 2018
• Study Protocol - Feb 3, 2017

More Information

Publications

None provided.

• Responsible Party: Golden Biotechnology Corporation
• ClinicalTrials.gov Identifier: NCT02719028
• Other Study ID Numbers: GHLIP-2-001
• First Posted: Mar 25, 2016
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias

Study Results

Participant Flow

Recruitment Details	A multi-center, phase II, prospective, double blind, randomized, placebo-controlled trial, recruiting from 23-Jun-2016 to 30-Aug-2018 6 sites are NTUniversity Hospital; CMU Hospital; NCKU Hospital; Taipei VG Hospital; FEM Hospital; CGM Hospital, Linkou branch;
Pre-assignment Detail	total treatment period: 16 weeks including a 2-week screening visit, a 12-week study treatment, and a 2-week follow-up

Arm/Group Title	Placebo	Antroquinonol 50 mg PO	Antroquinonol 100 mg PO	Antroquinonol 150 mg PO
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
Period Title: Overall Study
STARTED	30	30	30	30
COMPLETED	28	28	24	20
NOT COMPLETED	2	2	6	10

Baseline Characteristics

Arm/Group Title	Placebo	Antroquinonol 50 mg PO	Antroquinonol 100 mg PO	Antroquinonol 150 mg PO	Total
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Total of all reporting groups
Overall Participants	30	30	30	30	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.2 (15.12)	53.3 (13.18)	48.9 (10.32)	52.5 (9.98)	50.70 (12.37)
Sex: Female, Male (Count of Participants)
Female	12 40%	10 33.3%	5 16.7%	8 26.7%	35 29.2%
Male	18 60%	20 66.7%	25 83.3%	22 73.3%	85 70.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	30 100%	30 100%	30 100%	30 100%	120 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Taiwan	30 100%	30 100%	30 100%	30 100%	120 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.4 (4.71)	27.2 (3.80)	28.4 (5.41)	26.8 (3.72)	27.68 (4.36)

Outcome Measures

1. Primary Outcome

Title	TG Change (mg/dL )
Description	value at 12 weeks minus value at baseline
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Per-protocol population

Arm/Group Title	Placebo	Antroquinonol 50 mg PO	Antroquinonol 100 mg PO	Antroquinonol 150 mg PO
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
Measure Participants	28	28	22	20
Median (95% Confidence Interval) [percentage of change]	-9.2	14.6	-4.2	-1.3

2. Secondary Outcome

Title	LDL& HDL (mg/dL)
Description	value at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Antroquinonol 50 mg PO	Antroquinonol 100 mg PO	Antroquinonol 150 mg PO
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
Measure Participants	28	28	22	20
Mean (Standard Deviation) [percentage of change]	2.4 (21.73)	5.1 (23.02)	-1.1 (15.51)	0.3 (13.98)

3. Secondary Outcome

Title	Non-invasive Arterial Stiffness Measurement
Description	To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Per-protocol population

Arm/Group Title	Placebo	Antroquinonol 50 mg PO	Antroquinonol 100 mg PO	Antroquinonol 150 mg PO
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
Measure Participants	28	28	22	20
Mean (Standard Deviation) [percentage of change]	3.1 (9.58)	0.0 (13.80)	-3.3 (10.38)	2.8 (9.84)

4. Secondary Outcome

Title	Fatty Liver
Description	To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Only Per-protocol population subjects with abnormal liver attenuation at baseline subjected to follow-up after 12 weeks

Arm/Group Title	Placebo	Antroquinonol 50 mg PO	Antroquinonol 100 mg PO	Antroquinonol 150 mg PO
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
Measure Participants	15	13	12	11
Count of Participants [Participants]	0 0%	4 13.3%	1 3.3%	1 3.3%

Adverse Events

Time Frame	16 weeks start from Screening visit to follow up visit. The mean duration of dosing was 81.4 days in the placebo group, 81.3 days in the antroquinonol 50 mg group, 75.6 days in the antroquinonol 100 mg group, and 65.0 days in the antroquinonol 150 mg group.
Adverse Event Reporting Description	there are few patients had more than one AE during the study
Arm/Group Title	Placebo		Antroquinonol 50 mg PO		Antroquinonol 100 mg PO		Antroquinonol 150 mg PO
Arm/Group Description	Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (Placebo) 3 capsules once a day. placebo: The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)		Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (1 capsule of antroquinnonol 50mg and 2 capsules of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg		Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (2 capsules of antroquinnonol 50mg and 1 capsule of Placebo) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg		Subjects with screening central laboratory with a diagnosis of primary hypercholesterolemia (nonfamilial) or mixed hyperlipidemia (TG between 150 mg/dL and 500 mg/dL, and cholesterol between 160 mg/dL and 250 mg/dL or LDL-C > 130 mg/dL ) who meet inclusion/exclusion criteria will be randomized to 4 groups patient will take (antroquinnonol 50mg ) 3 capsules once a day. Antroquinonol: Antroquinonol will be provided as capsules of 50 mg
All Cause Mortality
	Placebo		Antroquinonol 50 mg PO		Antroquinonol 100 mg PO		Antroquinonol 150 mg PO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/14 (57.1%)		8/13 (61.5%)		12/19 (63.2%)		17/18 (94.4%)
Serious Adverse Events
	Placebo		Antroquinonol 50 mg PO		Antroquinonol 100 mg PO		Antroquinonol 150 mg PO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)		1/19 (5.3%)		0/18 (0%)
Renal and urinary disorders
ureterolithiasis and urinary tract disorder	0/14 (0%)	0	0/13 (0%)	0	1/19 (5.3%)	2	0/18 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Antroquinonol 50 mg PO		Antroquinonol 100 mg PO		Antroquinonol 150 mg PO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/14 (57.1%)		8/13 (61.5%)		12/19 (63.2%)		17/18 (94.4%)
Gastrointestinal disorders
Diarrhoea	4/14 (28.6%)	4	8/13 (61.5%)	8	9/19 (47.4%)	9	13/18 (72.2%)	13
Nausea	0/14 (0%)	0	0/13 (0%)	0	3/19 (15.8%)	3	3/18 (16.7%)	3
Vomiting	0/14 (0%)	0	1/13 (7.7%)	1	0/19 (0%)	0	3/18 (16.7%)	3
Hepatobiliary disorders
Hepatic function abnormal	2/14 (14.3%)	2	3/13 (23.1%)	3	0/19 (0%)	0	1/18 (5.6%)	1
Infections and infestations
Viral upper respiratory tract infection	2/14 (14.3%)	2	0/13 (0%)	0	0/19 (0%)	0	0/18 (0%)	0

Limitations/Caveats

Additional study with larger sample size is warranted to confirm antroquinonol in treating hyperlipidemia, arterial stiffness, and fatty liver.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.