A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
Hyperlipidemia
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
Subjects are eligible to be included in the study only if all of the following criteria apply:
- Ability to understand and comply with study procedures and give written informed consent
- Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period
- Males or post-menopausal females
- Aged ≥18 years at the time of informed consent
- Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at screening
- Serum HDL-C <50 mg/dL (<1.30 mmol/L) if male or <55 mg/dL (<1.42 mmol/L) if female at screening.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria apply:
Current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study.
i. Subjects currently on statins or ezetimibe must be at high risk for atherosclerotic CV diseases, and the dose(s) must be stable for at least 4 weeks prior to screening
ii. For subjects currently on lipid-altering medications other than statins or ezetimibe, at least 4-week washout period (or for subjects currently on probucol at least 8 week washout period) will be required prior to the first fasting blood sampling at Screening Visit
- Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) ≥8.0% at screening
- Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening
- Uncontrolled thyroid disorder
- Creatinine ≥1.5 mg/dL at screening
- Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT >2 × ULN at screening
- History of pancreatitis
- Gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history of disease or surgery that may affect the absorption, distribution, metabolism and excretion of drugs or the metabolism of bile salts
- Unexplained creatine kinase (CK) >5 × ULN at screening
- Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent
- New York Heart Association Class III or IV heart failure
- History of malignancy within 5 years
- Participation in another clinical study at the time of informed consent or administration of an investigational drug other than placebo within 16 weeks prior to the informed consent for this study
Sites / Locations
- Huainan First People's HospitalRecruiting
- Beijing Anzhen Hospital, Capital Medical University
- Beijing Hospital
- Beijing Tongren Hospital, Capital Medical University
- Beijing Pinggu Hospital
- Chengdu Xinhua HospitalRecruiting
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Peking Union Medical College Hospital
- The First Affiliated Hospital, Sun Yat-sen University
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Hainan General Hospital
- The Second Hospital of Hebei Medical UniversityRecruiting
- The First Affiliated Hospital of Harbin Medical UniversityRecruiting
- Union Hospital, Tongji Medical College of Huazhong University of Science & TechnologyRecruiting
- Tongji Hospital, Tongji Medical College of HUSTRecruiting
- Shaanxi Provincial People's HospitalRecruiting
- The Third Xiangya Hospital of Central South University
- The Third Hospital of ChangshaRecruiting
- Nanjing Jiangning Hospital
- Sir Run Run Hospital Nanjing Medical Universtiy
- Affiliated Hospital of Jiangsu UniversityRecruiting
- Jiangxi Provincial People's Hospital
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- The First Hospital of Nanchang
- Jiu Jiang No. 1 People's HospitalRecruiting
- Pingxiang People's HospitalRecruiting
- China-Japan Union Hospital of Jilin University
- Shanghai Tongren Hospital
- People's Hospital of Deyang City
- Tianjin Union Medical CenterRecruiting
- The Affiliated Hospital of Hangzhou Normal University
- People's Hospital of Wenzhou CityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
K-877 0.1 mg BID
K-877 0.2 mg BID
Fenofibrate 200 mg QD
Placebo
K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily
K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily
Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily
Placcebo tablet x 2 twice daily, Placebo capsule once daily