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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: K-877-ER (Dose A)
* Drug: K-877-ER (Dose B)
* Drug: K-877-IR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-877-ER Dose A<br>K-877-ER dose A administered once daily | Drug: K-877-ER (Dose A)<br>* Dose A Oral Administration<br>|
| Experimental: K-877-ER Dose B<br>K-877-ER dose B administered once daily | Drug: K-877-ER (Dose B)<br>* Dose B Oral Administration<br>|
| Experimental: K-877-IR<br>K-877-IR administered twice daily. | Drug: K-877-IR<br>* K-877-IR Oral Administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Percentage Change in Fasting Triglyceride(s) (TG) |  | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline to Day 28 in Total Cholesterol (TC) |  | Baseline to Day 28 | 
| Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C) |  | Baseline to Day 28 | 
| Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C) |  | Baseline to Day 28 | 
| Percentage Change From Baseline to Day 28 in Remnant Cholesterol |  | Baseline to Day 28 | 
| Percentage Change From Baseline to Day 28 in Non-HDL-C |  | Baseline to Day 28 | 
| Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs) |  | Baseline to Day 28 | 
| K-877 PK Parameters Cmax | Observed maximum measured plasma concentration (Cmax) | Day 28 | 
| K-877 PK Parameters AUC (Tau) |  | Day 28 |