Severe Hypertriglyceridemia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and \<2000 mg/dL and Mild or Moderate Renal Impairment.
Interventions
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent; 2. Aged ≥18 years; 3. Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4): 1. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack \[TIA\] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns); 2. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns); 3. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or 4. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin; 4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria; 1. Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, 3.a. through 3.d.); 2. Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or 3. Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference; 5. Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and \<2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1). * Mild to moderate renal impairment eGFR \>= 30mL/min/1.73 and \< 90 mL/min/1.73 at Visit 1
Exclusion criteria
1. Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (\>100 mg/day), omega-3 fatty acids (\>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols; 2. Body mass index (BMI) \>45 kg/m2 at Visit 1 (Week -8 or Week -6); 3. Patients with type 1 diabetes mellitus; 4. Patients with newly diagnosed (within 3 months prior to Visit 2 \[Week -2\]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c \>9.5% at Visit 1 (Week -8 or Week -6);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Fasting TG From Baseline to Week 12 | 12 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in Non-HDL-C | 12 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb) | 52 Weeks | — |
| Percent Change From Baseline to Week 12 in Remnant Cholesterol | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in HDL-C | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Total Cholesterol | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in LDL-C | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in FFAs | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo A2 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo B | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo B48 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo B100 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo C2 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo C3 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo E | 12 Weeks | — |
| Change From Baseline to Week 12 in FGF21 | 12 Weeks | — |
| Change From Baseline to Week 12 in hsCRP | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb) | 12 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc) | 52 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a) | 12 Weeks | Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction. |
| Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles) | 12 Weeks | Two types of lipoprotein particles were analyzed together as one measurement without distinction. |
| Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large) | 12 Weeks | Two types of lipoprotein particles were analyzed together as one measurement without distinction. |
| Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium) | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride) | 12 Weeks | Two types of lipoprotein particles were analyzed together as one measurement without distinction. |
| Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total) | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | 12 Weeks | — |
| Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | 12 Weeks | — |
| Percent Change From Baseline to Week 52 in Fasting TG | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Remnant Cholesterol | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in HDL-C | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo A1 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Non-HDL-C | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in TC | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in LDL-C | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in FFAs | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo A2 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo B | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo B48 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo B100 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo C2 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo C3 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Apo E | 52 Weeks | — |
| Change From Baseline to Week 52 in FGF21 | 52 Weeks | — |
| Change From Baseline to Week 52 in hsCRP | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a) | 52 Weeks | Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction. |
| Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles) | 52 Weeks | Two types of lipoprotein particles were analyzed together as one measurement without distinction. |
| Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large) | 52 Weeks | Two types of lipoprotein particles were analyzed together as one measurement without distinction. |
| Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium) | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles) | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles) | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large) | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles) | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large) | 52 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo A1 | 12 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride) | 52 Weeks | Two types of lipoprotein particles were analyzed together as one measurement without distinction. |
| Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol) | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | 52 Weeks | — |
| Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | 52 Weeks | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium) | 52 Weeks | — |
Countries
Belarus, Bulgaria, Czechia, Georgia, Hungary, Poland, Russia, Ukraine, United States
Participant flow
Pre-assignment details
Eligible patients entered a 4- to 6-week lifestyle stabilization period. The stabilization period was followed by a 2-week TG qualifying period, and patient eligibility was assessed based on the mean TG value from these 2 visits. If the patient's mean TG level during the TG qualifying period was ≥450 mg/dL (5.09 mmol/L) and \<500 mg/dL (5.65 mmol/L), an additional TG measurement was taken 1 week later at Visit 3.1. The mean of all 3 TG measurements was used to determine eligibility for the study.
Participants by arm
| Arm | Count |
|---|---|
| K-877 K-877 0.2 mg Tablets | 311 |
| Placebo/Fenofibrate Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period initiated fenofibrate dosing at 48 mg once daily at Visit 7 (Week 12). Starting from Visit 8 (Week 16), Investigators were allowed to adjust fenofibrate dosing (to 145 mg once daily) at their discretion according to the local standard of care. | 159 |
| Total | 470 |
Baseline characteristics
| Characteristic | K-877 | Placebo/Fenofibrate | Total |
|---|---|---|---|
| Age, Customized <65 years | 220 Participants | 119 Participants | 339 Participants |
| Age, Customized ≥65 years | 91 Participants | 40 Participants | 131 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 12 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 299 Participants | 151 Participants | 450 Participants |
| Race/Ethnicity, Customized Not reported/unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 302 Participants | 157 Participants | 459 Participants |
| Sex: Female, Male Female | 94 Participants | 40 Participants | 134 Participants |
| Sex: Female, Male Male | 217 Participants | 119 Participants | 336 Participants |
| Triglycerides | 793.44 mg/dL STANDARD_DEVIATION 390.102 | 759.36 mg/dL STANDARD_DEVIATION 395.359 | 781.45 mg/dL STANDARD_DEVIATION 391.511 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 311 | 0 / 159 | 3 / 292 | 1 / 154 |
| other Total, other adverse events | 0 / 311 | 0 / 159 | 2 / 292 | 8 / 154 |
| serious Total, serious adverse events | 11 / 311 | 3 / 159 | 25 / 292 | 5 / 154 |
Outcome results
Primary
Percent Change in Fasting TG From Baseline to Week 12
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change in Fasting TG From Baseline to Week 12 | -58.89 Percent change |
| Placebo | Percent Change in Fasting TG From Baseline to Week 12 | -22.94 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in FGF21
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in FGF21 | 277.97 pg/mL |
| Placebo | Change From Baseline to Week 12 in FGF21 | 12.15 pg/mL |
p-value: <0.0001Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in hsCRP
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in hsCRP | -0.201 mg/L |
| Placebo | Change From Baseline to Week 12 in hsCRP | -0.100 mg/L |
p-value: 0.4589Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 0.219 Ratio |
| Placebo | Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 0.026 Ratio |
p-value: <0.0001non-parametric Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large) | 0.22 µmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large) | 0.00 µmol/L |
p-value: 0.2879Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium) | -0.21 µmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium) | -0.23 µmol/L |
p-value: 0.9786Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small) | 1.54 µmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small) | 0.16 µmol/L |
p-value: 0.0075Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles) | -17.06 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles) | -2.74 nmol/L |
p-value: 0.0742Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large) | 54.52 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large) | 0.00 nmol/L |
p-value: <0.0001Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small) | 83.88 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small) | 12.43 nmol/L |
p-value: 0.2707Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large) | -12.62 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large) | -3.75 nmol/L |
p-value: <0.0001Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium) | -41.27 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium) | -9.13 nmol/L |
p-value: <0.0001Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small)
Time frame: 12 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small) | 0.46 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small) | 0.07 nmol/L |
p-value: 0.5107Hodges-Lehmann method
Secondary
Change From Baseline to Week 52 in FGF21
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in FGF21 | 371.80 pg/mL |
| Placebo | Change From Baseline to Week 52 in FGF21 | 194.40 pg/mL |
Secondary
Change From Baseline to Week 52 in hsCRP
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in hsCRP | -0.100 mg/L |
| Placebo | Change From Baseline to Week 52 in hsCRP | -0.225 mg/L |
Secondary
Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 0.210 Ratio |
| Placebo | Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 0.150 Ratio |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large) | 0.20 umol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large) | 0.30 umol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium) | -0.20 umol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium) | -0.40 umol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small) | 1.80 umol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small) | 1.40 umol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles) | -12.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles) | -6.00 nmol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large) | 53.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large) | 8.00 nmol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small) | 59.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small) | 97.00 nmol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large)
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large) | -13.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles-Large) | -8.60 nmol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium) | -41.95 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium) | -26.90 nmol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)
Time frame: 52 Weeks
Population: Since there were one or multiple records with a baseline value of 0, the percent change cannot be determined for such records. In such cases, the secondary endpoints were evaluated for change from baseline to week 52.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small) | -0.15 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small) | 0.00 nmol/L |
Secondary
Percent Change From Baseline to Week 12 in Apo A1
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo A1 | 4.05 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo A1 | 0.00 Percent change |
p-value: 0.0156Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo A2
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo A2 | 19.34 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo A2 | 0.00 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo B
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo B | 0.57 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo B | -1.67 Percent change |
p-value: 0.538Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo B100
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo B100 | 2.05 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo B100 | -2.33 Percent change |
p-value: 0.1165Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo B48
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo B48 | -36.64 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo B48 | 19.91 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo C2
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo C2 | -4.70 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo C2 | 0.00 Percent change |
p-value: 0.0142Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo C3
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo C3 | -41.97 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo C3 | -3.10 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Apo E
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Apo E | -29.09 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Apo E | -5.98 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in FFAs
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in FFAs | -25.25 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in FFAs | -5.51 Percent change |
p-value: 0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in HDL-C
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in HDL-C | 23.50 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in HDL-C | 7.33 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 2.67 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 0.14 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b) | -10.65 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b) | 0.91 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)
Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a) | -2.13 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a) | -0.53 Percent change |
p-value: 0.1651Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1) | -0.22 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1) | 2.42 Percent change |
p-value: 0.2486Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2) | 17.52 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2) | 3.21 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I) | 44.20 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I) | 4.81 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa) | 53.94 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa) | 4.24 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb) | 48.44 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb) | 1.89 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa) | 23.79 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa) | -0.80 Percent change |
p-value: 0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb) | -5.73 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb) | 0.71 Percent change |
p-value: 0.2763Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa) | -30.48 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa) | -2.89 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb) | -35.08 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb) | -0.74 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc) | -23.39 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc) | 0.89 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate) | -23.23 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate) | 0.07 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large) | -36.45 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large) | -5.95 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small) | -6.07 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small) | 4.16 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in LDL-C
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in LDL-C | 31.49 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in LDL-C | 2.30 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | -1.68 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | -1.25 Percent change |
p-value: 0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | -27.76 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | -0.47 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | -32.36 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | -9.02 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C | -32.36 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C | -9.02 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C | -66.21 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C | -26.81 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total) | 5.51 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total) | -2.20 Percent Change |
p-value: 0.0209Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles) | 5.96 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles) | -1.60 Percent change |
p-value: 0.0009Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size) | -1.19 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size) | -0.14 Percent Change |
p-value: 0.0502Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles) | 17.58 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles) | 4.97 Percent change |
p-value: 0.0018Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size) | 1.02 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size) | 0.00 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride) | -54.86 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride) | -15.24 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles) | -42.76 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles) | -5.59 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride) | -55.19 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride) | -16.20 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size) | -5.02 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size) | -2.26 Percent change |
p-value: 0.0241Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Non-HDL-C
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Non-HDL-C | -20.98 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Non-HDL-C | -3.43 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Remnant Cholesterol
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Remnant Cholesterol | -55.51 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Remnant Cholesterol | -13.29 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Total Cholesterol
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Total Cholesterol | -14.55 Percent change |
| Placebo | Percent Change From Baseline to Week 12 in Total Cholesterol | -2.05 Percent change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 52 in Apo A1
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo A1 | 3.29 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo A1 | 2.56 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo A2
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo A2 | 15.92 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo A2 | 8.33 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo B
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo B | -1.73 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo B | 0.00 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo B100
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo B100 | -1.32 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo B100 | -0.87 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo B48
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo B48 | -19.43 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo B48 | -15.19 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo C2
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo C2 | -9.56 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo C2 | 0.00 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo C3
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo C3 | -42.80 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo C3 | -26.25 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Apo E
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Apo E | -30.82 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Apo E | -30.00 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Fasting TG
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Fasting TG | -59.96 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Fasting TG | -49.55 Percent change |
Secondary
Percent Change From Baseline to Week 52 in FFAs
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in FFAs | -21.61 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in FFAs | -21.41 Percent change |
Secondary
Percent Change From Baseline to Week 52 in HDL-C
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in HDL-C | 18.78 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in HDL-C | 15.59 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 2.69 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 1.54 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b) | -11.67 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b) | -5.62 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a)
Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a) | -4.62 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 3 and 2a) | -3.71 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1) | 0.69 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1) | 3.54 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2) | 17.33 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2) | 15.87 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I) | 46.51 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I) | 25.53 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa) | 61.36 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa) | 33.66 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb) | 45.61 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb) | 27.29 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa) | 18.50 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa) | 19.64 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb) | -6.92 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb) | 1.17 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa) | -25.63 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa) | -24.80 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb) | -37.26 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb) | -24.22 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc) | -26.81 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc) | -17.41 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate) | -25.03 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate) | -13.31 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large) | -36.60 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large) | -22.03 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small) | -12.96 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small) | -2.31 Percent change |
Secondary
Percent Change From Baseline to Week 52 in LDL-C
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in LDL-C | 31.90 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in LDL-C | 22.96 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | -3.56 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | -2.94 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | -27.81 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | -13.17 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | -36.49 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | -27.67 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C | -31.53 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C | -23.70 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C | -66.38 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C | -56.61 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol) | 2.90 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol) | -1.19 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles) | 4.96 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles) | 0.00 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size) | -1.14 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size) | -1.15 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles) | 14.43 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles) | 12.79 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size) | 1.03 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size) | 0.51 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride) | -55.03 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride) | -42.76 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles) | -40.10 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles) | -28.98 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)
Two types of lipoprotein particles were analyzed together as one measurement without distinction.
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride) | -54.30 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride) | -41.55 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size) | -7.15 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size) | -5.46 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Non-HDL-C
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Non-HDL-C | -21.80 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Non-HDL-C | -14.22 Percent change |
Secondary
Percent Change From Baseline to Week 52 in Remnant Cholesterol
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Remnant Cholesterol | -58.39 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in Remnant Cholesterol | -43.31 Percent change |
Secondary
Percent Change From Baseline to Week 52 in TC
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in TC | -15.28 Percent change |
| Placebo | Percent Change From Baseline to Week 52 in TC | -8.64 Percent change |