A Phase III Long Term Study of K-877 Extended Release Tablet

Study Overview
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Brief Summary
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To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.

Official Title
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A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: K-877 ER 0.2 mg/day morning administration (once daily)
* Drug: K-877 ER 0.2 mg/day evening administration (once daily)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dyslipidemia had to be age 20 years or older at written informed consent Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening Patients with the fasting serum TG >= 150 mg/dL twice consecutively at Screening Exclusion Criteria: Patients with a fasting serum TG > 1000 mg/dL at Screening Patients who require administration of prohibited drugs during the clinical trial period after written informed consent Patients with uncontrolled thyroid disease Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening] Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg) Patients with an AST or ALT three times the upper limit at Screening Patients with an CK five times the upper limit at Screening Patients with cirrhosis or those with biliary obstruction Patients with acute myocardial infarction within 3 months before obtaining informed consent Patients with heart failure class III or higher according to NYHA cardiac function classification Patients with malignant tumor or those who are judged to have a high risk of recurrence Patients with a history of serious drug allergies (anaphylactic shock, etc.) Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening Patients who have received K-877 (pemafibrate) Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks Patients who have been determined inappropriate by the investigator, etc

Ages Eligible for Study
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Minimum Age: 20 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: morning administration<br>K-877 ER 0.2 mg/day morning administration (once daily) | Drug: K-877 ER 0.2 mg/day morning administration (once daily)<br>* K-877 ER 0.2 mg tablet<br>* Other names: Pemafibrate ER 0.2 mg/day morning administration (once daily);|
| Experimental: evening administration<br>K-877 ER 0.2 mg/day evening administration (once daily) | Drug: K-877 ER 0.2 mg/day evening administration (once daily)<br>* K-877 ER 0.2 mg tablet<br>* Other names: Pemafibrate ER 0.2 mg/day evening administration (once daily);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation |  | Final evaluation (Week 52 or at discontinuation) and immediately before it | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : Mean of percent change from baseline in fasting serum Total Cholesterol (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation |  | Final evaluation (Week 52 or at discontinuation) and immediately before it | 
| Efficacy : Mean of percent change from baseline in fasting serum LDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation |  | Final evaluation (Week 52 or at discontinuation) and immediately before it | 
| Efficacy : Mean of percent change from baseline in fasting serum HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation |  | Final evaluation (Week 52 or at discontinuation) and immediately before it | 
| Efficacy : Mean of percent change from baseline in fasting serum non-HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation |  | Final evaluation (Week 52 or at discontinuation) and immediately before it |