Dyslipidemias
Conditions
Brief summary
To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.
Interventions
DRUGK-877 ER 0.2 mg/day (once daily)
K-877 ER 0.2 mg tablet
DRUGK-877 ER 0.4 mg/day (once daily)
K-877 ER 0.4 mg tablet
DRUGK-877 IR 0.2 mg/day (twice daily)
K-877 IR 0.1 mg tablet
Sponsors
Kowa Company, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with dyslipidemia had to be age 20 years or older at written informed consent 2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening 3. Patients with the fasting serum TG \>= 200 mg/dL twice consecutively at Screening
Exclusion criteria
1. Patients with a fasting serum TG \> 1000 mg/dL at Screening 2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent 3. Patients with uncontrolled thyroid disease 4. Patients with type 1 diabetes and uncontrolled diabetes \[HbA1c(NGSP) \>= 8.0 % at Screening\] 5. Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg) 6. Patients with an AST or ALT three times the upper limit at Screening 7. Patients with an CK five times the upper limit at Screening 8. Patients with cirrhosis or those with biliary obstruction 9. Patients with acute myocardial infarction within 3 months before obtaining informed consent 10. Patients with heart failure class III or higher according to NYHA cardiac function classification 11. Patients with malignant tumor or those who are judged to have a high risk of recurrence 12. Patients with a history of serious drug allergies (anaphylactic shock, etc.) 13. 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 14. 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 15. Patients who have received K-877 (pemafibrate) 16. 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 17. Patients who have been determined inappropriate by the investigator, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy : % change from baseline in fasting serum TG (mg/dL) | 4, 8, and 12 week after administration |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL) | 4, 8, and 12 week after administration |
| Efficacy : % change from baseline in fasting serum LDL-C (mg/dL) | 4, 8, and 12 week after administration |
| Efficacy : % change from baseline in fasting serum HDL-C (mg/dL) | 4, 8, and 12 week after administration |
| Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL) | 4, 8, and 12 week after administration |
Countries
Japan
Outcome results
None listed