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 normal renal function.
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, criterion 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;
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 of Fasting Triglyceride(TG) Levels From Baseline to Week 12 | 12 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in HDL-C | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Apo A1 | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Non-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 Free Fatty Acids (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 | — |
| 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 | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total) | 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 Fibroblast Growth Factor 21 (FGF21) | 12 Weeks | — |
| Change From Baseline to Week 12 in hsCRP | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (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 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 | — |
| Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles | 12 Weeks | — |
| Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C | 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 - Major LDL Particle Measurement | 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. |
| Percent 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 - 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 (Total) | 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 | — |
| Percent 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 (Total) | 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 | 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 Non-HDL-C:HDL-C | 12 Weeks | — |
| Percent 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 | — |
| Change From Baseline to Week 52 in hsCRP | 52 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 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 | — |
| 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 - 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 52 in Ion Mobility - Low Density Lipoproteins IVc | 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 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 | 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. |
| Percent 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 | — |
| Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total) | 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 Remnant Cholesterol | 12 Weeks | — |
| Percent 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 | — |
| Percent 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 participants entered a 4- to 6-week lifestyle stabilization period followed by a 2-week TG qualifying period, used to determine eligibility for the study. After confirmation of qualifying fasting TG values, eligible participants entered a 12-week Efficacy Period. Participants who successfully completed the 12-week Efficacy Period were eligible to continue in a 40-week Extension Period.
Participants by arm
| Arm | Count |
|---|---|
| K-877 Participants randomized to receive K-877 0.2 mg BID in the 12-week Efficacy Period continued to receive K-877 0.2 mg BID, as well as placebo matching fenofibrate 145 mg once daily, in the 40-week Extension Period. | 368 |
| Placebo/Fenofibrate Participants randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period received fenofibrate 145 mg once daily and placebo matching K-877 0.2 mg BID in the 40-week Extension Period. | 183 |
| Total | 551 |
Baseline characteristics
| Characteristic | K-877 | Placebo/Fenofibrate | Total |
|---|---|---|---|
| Age, Customized Age (Years) <65 | 351 Participants | 176 Participants | 527 Participants |
| Age, Customized Age (Years) ≥65 | 17 Participants | 7 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 8 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 341 Participants | 175 Participants | 516 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 358 Participants | 180 Participants | 538 Participants |
| Sex: Female, Male Female | 97 Participants | 39 Participants | 136 Participants |
| Sex: Female, Male Male | 271 Participants | 144 Participants | 415 Participants |
| Triglycerides | 810.98 mg/dL STANDARD_DEVIATION 369.284 | 819.25 mg/dL STANDARD_DEVIATION 414.722 | 813.73 mg/dL STANDARD_DEVIATION 384.611 |
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 | 0 / 368 | 0 / 183 | 3 / 350 | 0 / 177 |
| other Total, other adverse events | 3 / 368 | 2 / 183 | 9 / 350 | 9 / 177 |
| serious Total, serious adverse events | 13 / 368 | 5 / 183 | 17 / 350 | 3 / 177 |
Outcome results
Primary
Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12 | -56.00 Percent of Change |
| Placebo | Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12 | -7.97 Percent of Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21) | 196.97 pg/mL |
| Placebo | Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21) | 3.88 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 | -0.051 mg/L |
| Placebo | Change From Baseline to Week 12 in hsCRP | -0.100 mg/L |
p-value: 0.7442Hodges-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 | 0.27 μmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large | 0.05 μmol/L |
p-value: 0.4346non-parametric Hodges-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 | -0.97 μmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium | 0.02 μmol/L |
p-value: 0.1474non-parametric Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (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 - Intermediate-density Lipoprotein (IDL) Particles | -5.52 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles | -0.21 nmol/L |
p-value: 0.1399Hodges-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 | 27.54 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large | 0.00 nmol/L |
p-value: 0.0122Hodges-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 | 87.75 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small | 23.85 nmol/L |
p-value: 0.0994Hodges-Lehmann method
Secondary
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
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 (Total) | 209.41 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total) | 51.43 nmol/L |
p-value: 0.0007Hodges-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 | -33.57 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium | 7.58 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 | 0.90 nmol/L |
| Placebo | Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small | -1.87 nmol/L |
p-value: 0.0647Hodges-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 | 259.20 pg/mL |
| Placebo | Change From Baseline to Week 52 in FGF21 | 207.50 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 | 0.000 mg/L |
| Placebo | Change From Baseline to Week 52 in hsCRP | -0.200 mg/L |
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 | 0.10 umol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large | -0.10 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 | -0.80 umol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium | -1.15 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 | -9.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles | -6.50 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 | 25.50 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large | 50.50 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 | 81.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small | 138.00 nmol/L |
Secondary
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
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 (Total) | 193.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total) | 213.50 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 | -34.20 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium | -20.70 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 | 0.00 nmol/L |
| Placebo | Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small | 3.85 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 | 1.21 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo A1 | 2.13 Percent Change |
p-value: 0.5443Hodges-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 | 15.30 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo A2 | 2.89 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 | 2.41 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo B | 3.73 Percent Change |
p-value: 0.4939Hodges-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 | 3.09 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo B100 | 2.76 Percent Change |
p-value: 0.8371Hodges-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 | -31.35 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo B48 | 22.62 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 | 0.00 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo C2 | 0.00 Percent Change |
p-value: 0.3415Hodges-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 | -39.56 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo C3 | 5.11 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 | -28.48 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Apo E | 0.56 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs) | -19.07 Percent Chage |
| Placebo | Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs) | 10.29 Percent Chage |
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 | 16.25 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in HDL-C | 4.00 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 | -7.34 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b | 2.04 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 | -2.01 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a | 1.76 Percent Change |
p-value: 0.0509Hodges-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 | 4.47 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1 | 2.10 Percent Change |
p-value: 0.7429Hodges-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 | 15.50 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2 | 3.06 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 | 45.24 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I | 1.04 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 | 59.36 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa | 0.75 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 | 61.87 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb | 1.26 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 | 33.08 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa | 0.85 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 | -1.50 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb | 1.11 Percent Change |
p-value: 0.3669Hodges-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 | -24.88 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa | -0.26 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 | -34.81 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb | 5.60 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 | -21.68 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc | 4.65 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement | 2.38 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement | -0.06 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate | -17.32 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate | 4.70 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large | -27.89 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large | 5.99 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small | -4.13 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small | 1.86 Percent Change |
p-value: 0.0374Hodges-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 | 31.93 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in LDL-C | 1.01 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 | 0.73 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | 2.47 Percent Change |
p-value: 0.9117Hodges-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 | -24.84 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | 7.50 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 30.90 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | -0.49 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 | -30.79 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | -4.49 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 | -62.64 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C | -11.22 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (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 Total Cholesterol (TC):HDL-C | -25.84 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C | -3.86 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol | -0.11 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol | -4.63 Percent Change |
p-value: 0.2049Hodges-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 | -1.14 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size | 0.00 Percent Change |
p-value: 0.0118Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small | 7.08 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small | -2.42 Percent Change |
p-value: 0.0054non-parametric Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total) | 2.87 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total) | -1.07 Percent Change |
p-value: 0.0904Hodges-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 | 1.00 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size | 0.01 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
Time frame: 12 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total) | -48.78 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total) | 8.43 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 | -37.93 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles | 5.37 Percent Change |
p-value: <0.0001Hodges-Lehmann method
Secondary
Percent 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large | -48.58 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large | 7.54 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 | -49.06 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride | 6.71 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 | -5.70 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size | 0.80 Percent Change |
p-value: 0.0002Hodges-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 | -16.07 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Non-HDL-C | 0.81 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 | -52.95 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Remnant Cholesterol | -3.36 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 | -11.26 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in Total Cholesterol | 1.55 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 | 1.63 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo A1 | 3.48 Percent of 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 | 9.26 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo A2 | 12.31 Percent of 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 | 0.93 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo B | 2.46 Percent of 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 | 1.48 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo B100 | 1.97 Percent of 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 | -14.04 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo B48 | -5.22 Percent of 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 | -8.70 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo C2 | -1.80 Percent of 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 | -36.70 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo C3 | -30.77 Percent of 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 | -29.94 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Apo E | -30.67 Percent of 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 | -57.93 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Fasting TG | -55.45 Percent of 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 | -18.08 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in FFAs | -13.64 Percent of 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 | 17.65 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in HDL-C | 19.35 Percent of Change |
Secondary
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
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 | 2.38 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle | 1.56 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 | -9.54 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b | -8.99 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 | -3.58 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a | -3.06 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 | 4.44 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1 | 8.23 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 | 21.05 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2 | 21.09 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 | 48.52 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I | 38.99 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 | 64.54 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa | 44.52 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 | 58.07 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb | 42.18 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 | 31.63 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa | 30.84 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 | 0.34 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb | 4.31 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 | -24.86 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa | -15.38 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 | -35.58 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb | -27.86 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 | -24.00 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc | -22.02 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 | -21.71 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate | -11.70 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 | -33.43 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large | -24.44 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 | -4.28 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small | -3.23 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 | 31.15 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in LDL-C | 36.84 Percent of 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 | 1.05 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | -1.76 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 | -20.98 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | -13.99 Percent Change |
Secondary
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 28.03 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 24.73 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 | -30.63 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | -32.36 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 | -27.21 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C | -27.59 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 | -63.46 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C | -65.21 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 | -3.88 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol | -2.63 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 | 1.07 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles | 1.38 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 | -1.15 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size | -1.11 Percent Change |
Secondary
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
Time frame: 52 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small | 9.01 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small | 6.37 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 | 0.99 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 | -48.01 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride | -48.29 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 | -39.09 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles | -30.29 Percent Change |
Secondary
Percent 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| K-877 | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large | -51.64 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large | -51.23 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 | -48.38 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride | -47.69 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 | -6.12 Percent Change |
| Placebo | Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size | -6.70 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 | -17.24 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Non-HDL-C | -15.71 Percent of 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 | -53.98 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in Remnant Cholesterol | -49.11 Percent of 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 | -11.84 Percent of Change |
| Placebo | Percent Change From Baseline to Week 52 in TC | -9.93 Percent of Change |