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

Primary Purpose

Hyperlipidemia

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
K-877 0.1 mg tablet
Fenofibrate 200 mg capsule
Placebo tablet
Placebo capsule
K-877 0.1 mg tablet
Placebo tablet
Sponsored by
Kowa Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

K-877 0.1 mg BID

K-877 0.2 mg BID

Fenofibrate 200 mg QD

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12
Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12

Secondary Outcome Measures

Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period
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)
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)
Percent change from baseline to the end of the treatment period in Apo A1 and Apo B
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
The incidence of adverse events and adverse drug reactions after the administration of the study drug
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
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

Full Information

First Posted
July 14, 2021
Last Updated
December 8, 2021
Sponsor
Kowa Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04998981
Brief Title
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
February 2, 2023 (Anticipated)
Study Completion Date
February 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
K-877 0.1 mg BID
Arm Type
Experimental
Arm Description
K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily
Arm Title
K-877 0.2 mg BID
Arm Type
Experimental
Arm Description
K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily
Arm Title
Fenofibrate 200 mg QD
Arm Type
Active Comparator
Arm Description
Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placcebo tablet x 2 twice daily, Placebo capsule once daily
Intervention Type
Drug
Intervention Name(s)
K-877 0.1 mg tablet
Other Intervention Name(s)
Pemafibrate
Intervention Description
K-877 0.1 mg tablet x 2 twice daily
Intervention Type
Drug
Intervention Name(s)
Fenofibrate 200 mg capsule
Intervention Description
Fenofibrate 200 mg capsule once daily
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Other Intervention Name(s)
Placebo tablet (matching K-877)
Intervention Description
Placebo tablet x 2 twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Other Intervention Name(s)
Placebo capsule (matching fenofibrate)
Intervention Description
Placebo capsule once daily
Intervention Type
Drug
Intervention Name(s)
K-877 0.1 mg tablet
Other Intervention Name(s)
Pemafibrate
Intervention Description
K-877 0.1 mg tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Other Intervention Name(s)
Placebo tablet (matching K-877)
Intervention Description
Placebo tablet twice daily
Primary Outcome Measure Information:
Title
Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12
Time Frame
From baseline to Weeks 8 and 12
Title
Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12
Time Frame
From baseline to Weeks 8 and 12
Secondary Outcome Measure Information:
Title
Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period
Time Frame
At Week 12
Title
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)
Time Frame
From baseline to Weeks 8 and 12
Title
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)
Time Frame
From baseline to Weeks 8 and 12
Title
Percent change from baseline to the end of the treatment period in Apo A1 and Apo B
Time Frame
From baseline to Week 12
Title
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
Time Frame
From baseline to Week 12
Title
The incidence of adverse events and adverse drug reactions after the administration of the study drug
Time Frame
Up to Week 12
Title
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
Time Frame
From baseline to Week 4, 8, and 12
Title
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
Time Frame
Up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keisuke Kunitomi
Phone
81-3-3279-7454
Email
ctrdinfo@kowa.co.jp
Facility Information:
Facility Name
Huainan First People's Hospital
City
Anhui
ZIP/Postal Code
232000
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Pinggu Hospital
City
Beijing
ZIP/Postal Code
101200
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chengdu Xinhua Hospital
City
Chengdu
ZIP/Postal Code
610066
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Guangdong
ZIP/Postal Code
100032
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hainan General Hospital
City
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Helongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
City
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Shaanxi Provincial People's Hospital
City
Hubei
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Third Hospital of Changsha
City
Hunan
ZIP/Postal Code
410015
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Jiangning Hospital
City
Jiangsu
ZIP/Postal Code
211100
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sir Run Run Hospital Nanjing Medical Universtiy
City
Jiangsu
ZIP/Postal Code
211100
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Affiliated Hospital of Jiangsu University
City
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Provincial People's Hospital
City
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Nanchang
City
Jiangxi
ZIP/Postal Code
330008
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Jiu Jiang No. 1 People's Hospital
City
Jiangxi
ZIP/Postal Code
332000
Country
China
Individual Site Status
Recruiting
Facility Name
Pingxiang People's Hospital
City
Jiangxi
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Union Hospital of Jilin University
City
Jilin
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanghai Tongren Hospital
City
Shanghai
ZIP/Postal Code
200336
Country
China
Individual Site Status
Not yet recruiting
Facility Name
People's Hospital of Deyang City
City
Sichuan
ZIP/Postal Code
618000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Union Medical Center
City
Tianjin
ZIP/Postal Code
300121
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Zhejiang
ZIP/Postal Code
310015
Country
China
Individual Site Status
Not yet recruiting
Facility Name
People's Hospital of Wenzhou City
City
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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