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Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
K-877-ER (Dose A)
K-877-ER (Dose B)
K-877-IR
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

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

Inclusion Criteria:

  • Able to provide written informed consent before any study-specific evaluation is performed
  • At screening, have a mean fasting TG level of ≥180 mg/dL and <550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and <500 mg/dL
  • Able to meet all inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

  • Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study
  • Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists
  • Meet any other exclusion criteria outlined in clinical study protocol

Sites / Locations

  • Pinnacle Research Group
  • Jacksonville Center for Clinical Research
  • Progressive Medical Research
  • Columbus Regional Health
  • Prism Research
  • Diabetes and Endocrinology Consultants, P.C.
  • Medpace Clinical Pharmacology, LLC
  • Aventiv Research, Inc.
  • Summit Research Group, LLC
  • Health Concepts
  • Clinical Trials of Texas, Inc.
  • Manassas Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

K-877-ER Dose A

K-877-ER Dose B

K-877-IR

Arm Description

K-877-ER dose A administered once daily

K-877-ER dose B administered once daily

K-877-IR administered twice daily.

Outcomes

Primary Outcome Measures

Percent change in fasting triglycerides (TG) from baseline to Day 28

Secondary Outcome Measures

Percent change in total cholesterol (TC)
Percent change in low-density lipoprotein cholesterol (LDL-C)
Percent change in HDL-C
Percent change in remnant cholesterol
Percent change in non-HDL-C
Percent change in free fatty acids.
K-877 plasma concentrations

Full Information

First Posted
June 19, 2020
Last Updated
December 1, 2021
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04447820
Brief Title
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Official Title
A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
December 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K-877-ER Dose A
Arm Type
Experimental
Arm Description
K-877-ER dose A administered once daily
Arm Title
K-877-ER Dose B
Arm Type
Experimental
Arm Description
K-877-ER dose B administered once daily
Arm Title
K-877-IR
Arm Type
Experimental
Arm Description
K-877-IR administered twice daily.
Intervention Type
Drug
Intervention Name(s)
K-877-ER (Dose A)
Intervention Description
Dose A Oral Administration
Intervention Type
Drug
Intervention Name(s)
K-877-ER (Dose B)
Intervention Description
Dose B Oral Administration
Intervention Type
Drug
Intervention Name(s)
K-877-IR
Intervention Description
K-877-IR Oral Administration
Primary Outcome Measure Information:
Title
Percent change in fasting triglycerides (TG) from baseline to Day 28
Time Frame
Baseline to Day 28
Secondary Outcome Measure Information:
Title
Percent change in total cholesterol (TC)
Time Frame
Baseline to Day 28
Title
Percent change in low-density lipoprotein cholesterol (LDL-C)
Time Frame
Baseline to Day 28
Title
Percent change in HDL-C
Time Frame
Baseline to Day 28
Title
Percent change in remnant cholesterol
Time Frame
Baseline to Day 28
Title
Percent change in non-HDL-C
Time Frame
Baseline to Day 28
Title
Percent change in free fatty acids.
Time Frame
Baseline to Day 28
Title
K-877 plasma concentrations
Time Frame
Days 1 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent before any study-specific evaluation is performed At screening, have a mean fasting TG level of ≥180 mg/dL and <550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and <500 mg/dL Able to meet all inclusion criteria outlined in clinical study protocol Exclusion Criteria: Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists Meet any other exclusion criteria outlined in clinical study protocol
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Columbus Regional Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Prism Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Diabetes and Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Medpace Clinical Pharmacology, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Summit Research Group, LLC
City
Munroe Falls
State/Province
Ohio
ZIP/Postal Code
44262
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States

12. IPD Sharing Statement

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Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

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