HyperlipidemiasPhase 2NCT02719028

Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

A Phase 2 study testing Antroquinonol in people with Hyperlipidemias, run by Golden Biotechnology Corporation at 6 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Hyperlipidemias
What is being tested?: Antroquinonol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 6 sitesTaiwan
Study dates: May 2016to 31 Mar 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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);
Subject must be free of any clinically significant disease, other than nonfamilial hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations;
A wash-out period of 2 weeks will be applied to patients prior treated with lipid-lowering medication;
Subject must be willing to adhere to protocol requirements, and provide written informed consent;
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.

Who cannot join

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)
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;
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);
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;
Patient has a known hypersensitivity to Antroquinonol or related compounds;
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;

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Patients with a history of heart transplant or who are on a transplant list or with left ventricular assistance device (LVAD device);
Patients with documented ventricular arrhythmia with syncopal episodes within the past 3 months prior to visit 1 that remained untreated;
Patients with confirmed severe primary pulmonary, renal (eGFR<30 ml/min/1.73 m2) or hepatic (Child-Pugh B/C classification) disease;
Patients who can't stop current lipid lowering drug treatments based on investigator's judgement;
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;
Female patient during pregnancy, lactation or breastfeeding;
Patient has any other life-threatening complications;
Patient who is considered unreliable as to medication compliance or adherence to scheduled appointments, or inappropriate for inclusion determined by the investigators;
Any other reasons addressed by the investigators.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Taiwan6 sites

Chang Gung Memorial Hospital, Linkou branch
New Taipei City
Far Eastern Memorial Hospital
New Taipei City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei

Other trials in Taiwan

About this study

Official title: A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

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

Read the 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.

Conditions: Hyperlipidemias
Being tested: Antroquinonol, placebo
Medical subject headings: Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AntroquinonolDrug
Also called Hocena 50mg
Antroquinonol will be provided as capsules of 50 mg
placeboDrug
The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)

Study groups in NCT02719028
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: placebo
Antroquinonol 50 mg PO	Experimental	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. Receives: Drug: Antroquinonol; Drug: placebo
Antroquinonol 100 mg PO	Experimental	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. Receives: Drug: Antroquinonol; Drug: placebo
Antroquinonol 150 mg PO	Experimental	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. Receives: Drug: Antroquinonol

What is being measured

The primary outcome is the main question the study is designed to answer.

TG Change (mg/dL )
value at 12 weeks minus value at baseline
Measured: 12 weeks

Secondary outcomes (3)

LDL& HDL (mg/dL)
value at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.
Measured: 12 weeks
Non-invasive Arterial Stiffness Measurement
To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.
Measured: 12 weeks
Fatty Liver
To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201631 Mar 2019

First posted25 Mar 2016 (estimated)
Study startMay 2016
Primary completion27 Sep 2018
Study completion31 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperlipidemiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02719028
Sponsor's protocol ID: GHLIP-2-001
Status last verified: Dec 2019
First submitted: 10 Mar 2016
Last updated: 2 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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RecruitingObservational study
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All Hyperlipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
ClinicalTrials.gov ID: NCT02719028
Acronym / sponsor ID: GHLIP-2-001
Conditions: Hyperlipidemias
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Golden Biotechnology CorporationIndustry (pharma, biotech, devices)
Study start: May 2016
Primary completion: 27 Sep 2018 (actual)
Study completion: 31 Mar 2019 (actual)
First posted: 25 Mar 2016 (estimated)
Results: Posted 20 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboSubjects 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.
Antroquinonol 50 mg PO	Experimental	Drug: Antroquinonol, Drug: placeboSubjects 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.
Antroquinonol 100 mg PO	Experimental	Drug: Antroquinonol, Drug: placeboSubjects 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.
Antroquinonol 150 mg PO	Experimental	Drug: AntroquinonolSubjects 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.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
Subject must be free of any clinically significant disease, other than nonfamilial hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations;
A wash-out period of 2 weeks will be applied to patients prior treated with lipid-lowering medication;
Subject must be willing to adhere to protocol requirements, and provide written informed consent;
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.

Key exclusion criteria (15 listed)

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)
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;
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);
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;
Patient has a known hypersensitivity to Antroquinonol or related compounds;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AntroquinonolAlso: Hocena 50mgAntroquinonol will be provided as capsules of 50 mg	Drug	Antroquinonol 100 mg PO, Antroquinonol 150 mg PO, Antroquinonol 50 mg PO
placeboThe matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)	Drug	Antroquinonol 100 mg PO, Antroquinonol 50 mg PO, Placebo

Primary outcome

TG Change (mg/dL )
Time frame: 12 weeks
value at 12 weeks minus value at baseline

3 secondary outcomes

LDL& HDL (mg/dL)
Time frame: 12 weeks
Non-invasive Arterial Stiffness Measurement
Time frame: 12 weeks
Fatty Liver
Time frame: 12 weeks

Results and safety

Results posted to the registry on 20 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	30	28
Antroquinonol 50 mg PO	30	28
Antroquinonol 100 mg PO	30	24
Antroquinonol 150 mg PO	30	20

Primary outcome: TG Change (mg/dL )

Time frame: 12 weeks. Median (95% Confidence Interval). Unit: percentage of change

Measure	Placebo n = 28	Antroquinonol 50 mg PO n = 28	Antroquinonol 100 mg PO n = 22	Antroquinonol 150 mg PO n = 20
Value	-9.2 (-17.97 to 12.20)	14.6 (3.48 to 40.8)	-4.2 (-15.68 to 15.80)	-1.3 (-13.01 to 15.17)

Population analysed: Per-protocol population

3 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 14 (0%)	8 of 14 (57.1%)	8 of 14
Antroquinonol 50 mg PO	0 of 13 (0%)	8 of 13 (61.5%)	8 of 13
Antroquinonol 100 mg PO	1 of 19 (5.3%)	12 of 19 (63.2%)	12 of 19
Antroquinonol 150 mg PO	0 of 18 (0%)	17 of 18 (94.4%)	17 of 18

Limitations and caveats (from the sponsor): Additional study with larger sample size is warranted to confirm antroquinonol in treating hyperlipidemia, arterial stiffness, and fatty liver.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hyperlipidemias

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fu-Tien Chiang, M.D. principal investigator

National Taiwan University Hopspital

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antroquinonol in people with Hyperlipidemias, run by Golden Biotechnology Corporation at 6 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TG Change (mg/dL ) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02719028.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.