Clinical trial NCT04447820: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Estimated Percentage Change in Fasting Triglyceride(s) (TG)
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)
timeFrame: Baseline to Day 28
measure: Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline to Day 28
measure: Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline to Day 28
measure: Percentage Change From Baseline to Day 28 in Remnant Cholesterol
timeFrame: Baseline to Day 28
measure: Percentage Change From Baseline to Day 28 in Non-HDL-C
timeFrame: Baseline to Day 28
measure: Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)
timeFrame: Baseline to Day 28
measure: K-877 PK Parameters Cmax
timeFrame: Day 28
measure: K-877 PK Parameters AUC (Tau)
timeFrame: Day 28
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Health
state: Georgia
city: Saint Paul
country: United States
facility: Prism Research
state: Minnesota
city: Morehead City
country: United States
facility: Diabetes and Endocrinology Consultants, P.C.
state: North Carolina
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology, LLC
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Munroe Falls
country: United States
facility: Summit Research Group, LLC
state: Ohio
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
References: