A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

Hyperlipidemia Clinical Trial

Official title:

A Phase 3, Multi-Center, Placebo- and Active-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998981
• Other study ID #: K-877-3.01CH
• Status: Recruiting
• Phase: Phase 3
• Start date: September 17, 2021
• Est. completion date: February 2, 2023

Study information

• Verified date: December 2021
• Source: Kowa Company, Ltd.
• Contact: Keisuke Kunitomi
• Phone: 81-3-3279-7454
• Email: ctrdinfo[@]kowa.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria

apply:

1. Ability to understand and comply with study procedures and give written informed consent

2. Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period

3. Males or post-menopausal females

4. Aged =18 years at the time of informed consent

5. Fasting serum TG levels =200 mg/dL (=2.26 mmol/L) and =500 mg/dL (5.65 mmol/L) at screening

6. 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:

1. 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

2. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) =8.0% at screening

3. Uncontrolled hypertension defined by seated systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg at screening

4. Uncontrolled thyroid disorder

5. Creatinine =1.5 mg/dL at screening

6. Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT >2 × ULN at screening

7. History of pancreatitis

8. 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

9. Unexplained creatine kinase (CK) >5 × ULN at screening

10. Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent

11. New York Heart Association Class III or IV heart failure

12. History of malignancy within 5 years

13. 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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• K-877 0.1 mg tablet
K-877 0.1 mg tablet x 2 twice daily
• Fenofibrate 200 mg capsule
Fenofibrate 200 mg capsule once daily
• Placebo tablet
Placebo tablet x 2 twice daily
• Placebo capsule
Placebo capsule once daily
• K-877 0.1 mg tablet
K-877 0.1 mg tablet twice daily
• Placebo tablet
Placebo tablet twice daily

Locations

Country	Name	City	State
China	Huainan First People's Hospital	Anhui
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing
China	Beijing Pinggu Hospital	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing
China	Chengdu Xinhua Hospital	Chengdu
China	The First Affiliated Hospital of Fujian Medical University	Fujian
China	Peking Union Medical College Hospital	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangdong
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Guangxi
China	Hainan General Hospital	Hainan
China	The Second Hospital of Hebei Medical University	Hebei
China	The First Affiliated Hospital of Harbin Medical University	Helongjiang
China	Shaanxi Provincial People's Hospital	Hubei
China	Tongji Hospital, Tongji Medical College of HUST	Hubei
China	Union Hospital, Tongji Medical College of Huazhong University of Science & Technology	Hubei
China	The Third Hospital of Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Hunan
China	Affiliated Hospital of Jiangsu University	Jiangsu
China	Nanjing Jiangning Hospital	Jiangsu
China	Sir Run Run Hospital Nanjing Medical Universtiy	Jiangsu
China	Jiangxi Provincial People's Hospital	Jiangxi
China	Jiu Jiang No. 1 People's Hospital	Jiangxi
China	Pingxiang People's Hospital	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Jiangxi
China	The First Hospital of Nanchang	Jiangxi
China	China-Japan Union Hospital of Jilin University	Jilin
China	Shanghai Tongren Hospital	Shanghai
China	People's Hospital of Deyang City	Sichuan
China	Tianjin Union Medical Center	Tianjin
China	People's Hospital of Wenzhou City	Zhejiang
China	The Affiliated Hospital of Hangzhou Normal University	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12		From baseline to Weeks 8 and 12
Primary	Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12		From baseline to Weeks 8 and 12
Secondary	Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period		At Week 12
Secondary	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
Secondary	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
Secondary	Percent change from baseline to the end of the treatment period in Apo A1 and Apo B		From baseline to Week 12
Secondary	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
Secondary	The incidence of adverse events and adverse drug reactions after the administration of the study drug		Up to Week 12
Secondary	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
Secondary	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