A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
NCT ID: NCT04998981
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
353 participants
INTERVENTIONAL
2021-09-17
2023-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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K-877 0.1 mg BID
K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once 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
K-877 0.2 mg BID
K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily
K-877 0.1 mg tablet
K-877 0.1 mg tablet x 2 twice daily
Placebo capsule
Placebo capsule once daily
Fenofibrate 200 mg QD
Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily
Fenofibrate 200 mg capsule
Fenofibrate 200 mg capsule once daily
Placebo tablet
Placebo tablet x 2 twice daily
Placebo
Placcebo tablet x 2 twice daily, Placebo capsule once daily
Placebo tablet
Placebo tablet x 2 twice daily
Placebo capsule
Placebo capsule once daily
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Kowa Company, Ltd.
INDUSTRY
Responsible Party
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Locations
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Huainan First People's Hospital
Anhui, , China
Beijing Anzhen Hospital, Capital Medical University
Beijing, , China
Beijing Hospital
Beijing, , China
Beijing Tongren Hospital, Capital Medical University
Beijing, , China
Beijing Pinggu Hospital
Beijing, , China
Chengdu Xinhua Hospital
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fujian, , China
Peking Union Medical College Hospital
Guangdong, , China
The First Affiliated Hospital, Sun Yat-sen University
Guangdong, , China
Sun Yat-sen Memorial 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
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Hubei, , China
Tongji Hospital, Tongji Medical College of HUST
Hubei, , China
Shaanxi Provincial People's Hospital
Hubei, , China
The Third Xiangya Hospital of Central South University
Hunan, , China
The Third Hospital of Changsha
Hunan, , China
Nanjing Jiangning Hospital
Jiangsu, , China
Sir Run Run Hospital Nanjing Medical Universtiy
Jiangsu, , China
Affiliated Hospital of Jiangsu University
Jiangsu, , China
Jiangxi Provincial People's Hospital
Jiangxi, , China
The First Affiliated Hospital of Nanchang University
Jiangxi, , China
The First Hospital of Nanchang
Jiangxi, , China
Jiu Jiang No. 1 People's Hospital
Jiangxi, , China
Pingxiang People's Hospital
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
The Affiliated Hospital of Hangzhou Normal University
Zhejiang, , China
People's Hospital of Wenzhou City
Zhejiang, , China
Countries
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References
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Dai W, Lv Q, Li Q, Fu L, Zhang Y, Zhang Y, Liu L, Tanigawa R, Kunitomi K, Kamei R, Suganami H, Ma C. Efficacy and Safety of Pemafibrate, a Novel Selective PPARalpha Modulator in Chinese Patients with Dyslipidemia: A Double-Masked, Randomized, Placebo- and Active-Controlled Comparison Trial. J Atheroscler Thromb. 2025 Feb 1;32(2):125-140. doi: 10.5551/jat.64112. Epub 2024 Aug 2.
Other Identifiers
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K-877-3.01CH
Identifier Type: -
Identifier Source: org_study_id
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