A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT04998981
- Lead Sponsor
- Kowa Company, Ltd.
- Brief Summary
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 350
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description K-877 0.1 mg BID Placebo capsule K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily K-877 0.1 mg BID K-877 0.1 mg tablet K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily K-877 0.1 mg BID Placebo tablet K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily K-877 0.2 mg BID K-877 0.1 mg tablet K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily K-877 0.2 mg BID Placebo capsule K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily Fenofibrate 200 mg QD Fenofibrate 200 mg capsule Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily Fenofibrate 200 mg QD Placebo tablet Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily Placebo Placebo tablet Placcebo tablet x 2 twice daily, Placebo capsule once daily Placebo Placebo capsule Placcebo tablet x 2 twice daily, Placebo capsule once daily
- Primary Outcome Measures
Name Time Method Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12 From baseline to Weeks 8 and 12 Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12 From baseline to Weeks 8 and 12
- Secondary Outcome Measures
Name Time Method Percent change from baseline to the end of the treatment period in Apo A1 and Apo B From baseline to Week 12 Percent change from baseline to the end of the treatment period in TG/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, LDL-C/HDL-C, LDL-C/Apo B, and Apo B/Apo A1 From baseline to Week 12 The incidence of adverse events and adverse drug reactions after the administration of the study drug Up to Week 12 Change from baseline to Week 4, 8, and 12 in clinical laboratory tests (chemistry, hematology), vital signs (BP [mmHg], PR [bpm], weight [kg], waist [cm], and BMI [kg/m^2]; each parameter is evaluated individually.), 12-lead ECGs From baseline to Week 4, 8, and 12 Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period At Week 12 Percent change from baseline to Weeks 8 and 12 in TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated) From baseline to Weeks 8 and 12 Change from baseline to Weeks 8 and 12 in fasting TG, TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated) From baseline to Weeks 8 and 12 Number and percentage of patients who experience laboratory abnormalities of special interest including, but not limited to ALT, AST, ALP, CK, and, creatinine during the treatment period Up to Week 12
Trial Locations
- Locations (33)
Huainan First People's Hospital
🇨🇳Anhui, China
Beijing Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fujian, China
Beijing Pinggu Hospital
🇨🇳Beijing, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Guangxi, China
Peking Union Medical College Hospital
🇨🇳Guangdong, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Hubei, China
Hainan General Hospital
🇨🇳Hainan, China
Chengdu Xinhua Hospital
🇨🇳Chengdu, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China
Tongji Hospital, Tongji Medical College of HUST
🇨🇳Hubei, China
The Third Hospital of Changsha
🇨🇳Hunan, China
Affiliated Hospital of Jiangsu University
🇨🇳Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Jiangxi, China
Jiu Jiang No. 1 People's Hospital
🇨🇳Jiangxi, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Zhejiang, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangdong, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Helongjiang, China
The Second Hospital of Hebei Medical University
🇨🇳Hebei, China
Shaanxi Provincial People's Hospital
🇨🇳Hubei, China
Nanjing Jiangning Hospital
🇨🇳Jiangsu, China
The Third Xiangya Hospital of Central South University
🇨🇳Hunan, China
Sir Run Run Hospital Nanjing Medical Universtiy
🇨🇳Jiangsu, China
China-Japan Union Hospital of Jilin University
🇨🇳Jilin, China
Tianjin Union Medical Center
🇨🇳Tianjin, China
The First Hospital of Nanchang
🇨🇳Jiangxi, China
Pingxiang People's Hospital
🇨🇳Jiangxi, China
Shanghai Tongren Hospital
🇨🇳Shanghai, China
People's Hospital of Deyang City
🇨🇳Sichuan, China
People's Hospital of Wenzhou City
🇨🇳Zhejiang, China
The First Affiliated Hospital of Nanchang University
🇨🇳Jiangxi, China