Hyperlipidemia
Conditions
Brief summary
A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C
Interventions
DRUGK-877 0.1 mg tablet
K-877 0.1 mg tablet x 2 twice daily
DRUGFenofibrate 200 mg capsule
Fenofibrate 200 mg capsule once daily
DRUGPlacebo tablet
Placebo tablet x 2 twice daily
DRUGPlacebo capsule
Placebo capsule once daily
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Ability to understand and comply with study procedures and give written informed consent 2. Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period 3. Males or post-menopausal females 4. Aged ≥18 years at the time of informed consent 5. Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at screening 6. Serum HDL-C \<50 mg/dL (\<1.30 mmol/L) if male or \<55 mg/dL (\<1.42 mmol/L) if female at screening.
Exclusion criteria
Subjects are excluded from the study if any of the following criteria apply: 1. Current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study. i. Subjects currently on statins or ezetimibe must be at high risk for atherosclerotic CV diseases, and the dose(s) must be stable for at least 4 weeks prior to screening ii. For subjects currently on lipid-altering medications other than statins or ezetimibe, at least 4-week washout period (or for subjects currently on probucol at least 8 week washout period) will be required prior to the first fasting blood sampling at Screening Visit 2. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) ≥8.0% at screening 3. Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening 4. Uncontrolled thyroid disorder 5. Creatinine ≥1.5 mg/dL at screening 6. Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT \>2 × ULN at screening 7. History of pancreatitis 8. Gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history of disease or surgery that may affect the absorption, distribution, metabolism and excretion of drugs or the metabolism of bile salts 9. Unexplained creatine kinase (CK) \>5 × ULN at screening 10. Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent 11. New York Heart Association Class III or IV heart failure 12. History of malignancy within 5 years 13. Participation in another clinical study at the time of informed consent or administration of an investigational drug other than placebo within 16 weeks prior to the informed consent for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12 | From baseline to Weeks 8 and 12 |
| Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12 | From baseline to Weeks 8 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Weeks 8 and 12 in fasting TG, TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated) | From baseline to Weeks 8 and 12 |
| Percent change from baseline to the end of the treatment period in Apo A1 and Apo B | From baseline to Week 12 |
| Percent change from baseline to the end of the treatment period in TG/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, LDL-C/HDL-C, LDL-C/Apo B, and Apo B/Apo A1 | From baseline to Week 12 |
| Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period | At Week 12 |
| Change from baseline to Week 4, 8, and 12 in clinical laboratory tests (chemistry, hematology), vital signs (BP [mmHg], PR [bpm], weight [kg], waist [cm], and BMI [kg/m^2]; each parameter is evaluated individually.), 12-lead ECGs | From baseline to Week 4, 8, and 12 |
| Number and percentage of patients who experience laboratory abnormalities of special interest including, but not limited to ALT, AST, ALP, CK, and, creatinine during the treatment period | Up to Week 12 |
| The incidence of adverse events and adverse drug reactions after the administration of the study drug | Up to Week 12 |
| Percent change from baseline to Weeks 8 and 12 in TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated) | From baseline to Weeks 8 and 12 |
Countries
China
Outcome results
None listed