Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

NCT02719028 | Completed Phase 2 Results

• 1 other identifier: GHLIP-2-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (1)

• TG Change (mg/dL )

  value at 12 weeks minus value at baseline

  12 weeks

Secondary Outcomes (3)

• LDL& HDL (mg/dL)

  12 weeks

• Non-invasive Arterial Stiffness Measurement

  12 weeks

• Fatty Liver

  12 weeks

Study Arms (4)

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.

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.

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.

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.

Drug: Antroquinonol

Interventions

Antroquinonol DRUG

Antroquinonol will be provided as capsules of 50 mg

Also known as: Hocena 50mg

Antroquinonol 100 mg PO; Antroquinonol 150 mg PO; Antroquinonol 50 mg PO

placebo DRUG

The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)

Antroquinonol 100 mg PO; Antroquinonol 50 mg PO; Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Any other reasons addressed by the investigators.

Sponsors & Collaborators

• Golden Biotechnology Corporation: lead

Study Sites (6)

Chang Gung Memorial Hospital, Linkou branch

New Taipei City, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

antroquinonol

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Howard Cheng
• Organization: Golden Biotechnology Corp

howard@goldenbiotech.com

+886-2-28086006

Study Officials

• Fu-Tien Chiang, M.D.

  National Taiwan University Hopspital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 25, 2016
• Study Start: May 1, 2016
• Primary Completion: September 27, 2018
• Study Completion: March 31, 2019
• Last Updated: January 2, 2020
• Results First Posted: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)