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CompletedNCT03001817Updated Nov 30, 2022Results posted

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

A Phase 3 interventional study of K-877 and Fenofibrate in Severe Hypertriglyceridemia, sponsored by Kowa Research Institute, Inc.. Completed at 220 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Kowa Research Institute, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
551
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Severe Hypertriglyceridemia

Browse trials for

03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 551 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Kowa Research Institute, Inc. is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 9 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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);
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
551 participants (actual)

Study arms

  • Placebo comparator
    12 Week Efficacy

    K-877 or placebo comparator twice daily for 12 weeks

    Drug: K-877 · Drug: Placebo (for K-877)

  • Active comparator
    40 Week Extension

    K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks

    Drug: K-877 · Drug: Fenofibrate · Drug: Placebo (for K-877) · Drug: Placebo (for Fenofibrate)

Interventions

  • DrugK-877
  • DrugFenofibrate
  • DrugPlacebo (for K-877)
  • DrugPlacebo (for Fenofibrate)
06

What researchers measure

Primary outcomes

  1. Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12

    Time frame: 12 Weeks

Secondary outcomes

  1. Percent Change From Baseline to Week 12 in Remnant Cholesterol

    Time frame: 12 Weeks

  2. Percent Change From Baseline to Week 12 in HDL-C

    Time frame: 12 Weeks

  3. Percent Change From Baseline to Week 12 in Apo A1

    Time frame: 12 Weeks

  4. Percent Change From Baseline to Week 12 in Non-HDL-C

    Time frame: 12 Weeks

  5. Percent Change From Baseline to Week 12 in Total Cholesterol

    Time frame: 12 Weeks

  6. Percent Change From Baseline to Week 12 in LDL-C

    Time frame: 12 Weeks

  7. Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)

    Time frame: 12 Weeks

  8. Percent Change From Baseline to Week 12 in Apo A2

    Time frame: 12 Weeks

  9. Percent Change From Baseline to Week 12 in Apo B

    Time frame: 12 Weeks

  10. Percent Change From Baseline to Week 12 in Apo B48

    Time frame: 12 Weeks

  11. Percent Change From Baseline to Week 12 in Apo B100

    Time frame: 12 Weeks

  12. Percent Change From Baseline to Week 12 in Apo C2

    Time frame: 12 Weeks

  13. Percent Change From Baseline to Week 12 in Apo C3

    Time frame: 12 Weeks

  14. Percent Change From Baseline to Week 12 in Apo E

    Time frame: 12 Weeks

  15. Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)

    Time frame: 12 Weeks

  16. Change From Baseline to Week 12 in hsCRP

    Time frame: 12 Weeks

  17. Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large

    Time frame: 12 Weeks

  18. Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate

    Time frame: 12 Weeks

  19. Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small

    Time frame: 12 Weeks

  20. Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1

    Time frame: 12 Weeks

  21. Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2

    Time frame: 12 Weeks

  22. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I

    Time frame: 12 Weeks

  23. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa

    Time frame: 12 Weeks

  24. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb

    Time frame: 12 Weeks

  25. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa

    Time frame: 12 Weeks

  26. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb

    Time frame: 12 Weeks

  27. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa

    Time frame: 12 Weeks

  28. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb

    Time frame: 12 Weeks

  29. Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc

    Time frame: 12 Weeks

  30. Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b

    Time frame: 12 Weeks

  31. 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

  32. Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement

    Time frame: 12 Weeks

  33. 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

  34. 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

  35. Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium

    Time frame: 12 Weeks

  36. Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small

    Time frame: 12 Weeks

  37. Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)

    Time frame: 12 Weeks

  38. Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles

    Time frame: 12 Weeks

  39. Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large

    Time frame: 12 Weeks

  40. Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small

    Time frame: 12 Weeks

  41. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)

    Time frame: 12 Weeks

  42. Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large

    Time frame: 12 Weeks

  43. Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium

    Time frame: 12 Weeks

  44. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small

    Time frame: 12 Weeks

  45. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size

    Time frame: 12 Weeks

  46. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size

    Time frame: 12 Weeks

  47. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size

    Time frame: 12 Weeks

  48. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)

    Time frame: 12 Weeks

  49. 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

  50. Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol

    Time frame: 12 Weeks

  51. Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C

    Time frame: 12 Weeks

  52. Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C

    Time frame: 12 Weeks

  53. Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C

    Time frame: 12 Weeks

  54. Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B

    Time frame: 12 Weeks

  55. Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1

    Time frame: 12 Weeks

  56. Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2

    Time frame: 12 Weeks

  57. Percent Change From Baseline to Week 52 in Fasting TG

    Time frame: 52 Weeks

  58. Percent Change From Baseline to Week 52 in Remnant Cholesterol

    Time frame: 52 Weeks

  59. Percent Change From Baseline to Week 52 in HDL-C

    Time frame: 52 Weeks

  60. Percent Change From Baseline to Week 52 in Apo A1

    Time frame: 52 Weeks

  61. Percent Change From Baseline to Week 52 in Non-HDL-C

    Time frame: 52 Weeks

  62. Percent Change From Baseline to Week 52 in TC

    Time frame: 52 Weeks

  63. Percent Change From Baseline to Week 52 in LDL-C

    Time frame: 52 Weeks

  64. Percent Change From Baseline to Week 52 in FFAs

    Time frame: 52 Weeks

  65. Percent Change From Baseline to Week 52 in Apo A2

    Time frame: 52 Weeks

  66. Percent Change From Baseline to Week 52 in Apo B

    Time frame: 52 Weeks

  67. Percent Change From Baseline to Week 52 in Apo B48

    Time frame: 52 Weeks

  68. Percent Change From Baseline to Week 52 in Apo B100

    Time frame: 52 Weeks

  69. Percent Change From Baseline to Week 52 in Apo C2

    Time frame: 52 Weeks

  70. Percent Change From Baseline to Week 52 in Apo C3

    Time frame: 52 Weeks

  71. Percent Change From Baseline to Week 52 in Apo E

    Time frame: 52 Weeks

  72. Change From Baseline to Week 52 in FGF21

    Time frame: 52 Weeks

  73. Change From Baseline to Week 52 in hsCRP

    Time frame: 52 Weeks

  74. Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large

    Time frame: 52 Weeks

  75. Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate

    Time frame: 52 Weeks

  76. Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small

    Time frame: 52 Weeks

  77. Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1

    Time frame: 52 Weeks

  78. Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2

    Time frame: 52 Weeks

  79. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I

    Time frame: 52 Weeks

  80. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa

    Time frame: 52 Weeks

  81. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb

    Time frame: 52 Weeks

  82. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa

    Time frame: 52 Weeks

  83. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb

    Time frame: 52 Weeks

  84. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa

    Time frame: 52 Weeks

  85. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb

    Time frame: 52 Weeks

  86. Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc

    Time frame: 52 Weeks

  87. Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b

    Time frame: 52 Weeks

  88. 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

  89. Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle

    Time frame: 52 Weeks

  90. 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

  91. 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

  92. Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium

    Time frame: 52 Weeks

  93. Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small

    Time frame: 52 Weeks

  94. Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)

    Time frame: 52 Weeks

  95. Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles

    Time frame: 52 Weeks

  96. Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large

    Time frame: 52 Weeks

  97. Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small

    Time frame: 52 Weeks

  98. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles

    Time frame: 52 Weeks

  99. Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large

    Time frame: 52 Weeks

  100. Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium

    Time frame: 52 Weeks

  101. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small

    Time frame: 52 Weeks

  102. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size

    Time frame: 52 Weeks

  103. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size

    Time frame: 52 Weeks

  104. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size

    Time frame: 52 Weeks

  105. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride

    Time frame: 52 Weeks

  106. 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

  107. Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol

    Time frame: 52 Weeks

  108. Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C

    Time frame: 52 Weeks

  109. Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C

    Time frame: 52 Weeks

  110. Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C

    Time frame: 52 Weeks

  111. Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B

    Time frame: 52 Weeks

  112. Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1

    Time frame: 52 Weeks

  113. Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2

    Time frame: 52 Weeks

07

Results

Posted Nov 30, 2022

Participant flow

12 Week Efficacy
Participant flow — 12 Week Efficacy
MilestoneK-877Placebo/Fenofibrate
Started368183
Completed356179
Not completed124
40 Week Extension
Participant flow — 40 Week Extension
MilestoneK-877Placebo/Fenofibrate
Started350177
Completed335163
Not completed1514

Outcome measures

PrimaryPercent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
Time frame:
12 Weeks
Reported as:
Median · Percent of Change
Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
Percent of ChangeK-877Placebo
Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12-56.00 (-72.08 to -32.40)-7.97 (-44.78 to 49.87)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Remnant Cholesterol
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Remnant Cholesterol
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Remnant Cholesterol-52.95 (-67.97 to -27.64)-3.36 (-31.18 to 39.47)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in HDL-C
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in HDL-C
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in HDL-C16.25 (-1.13 to 40.15)4.00 (-8.91 to 15.58)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann Method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Apo A1
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo A1
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo A11.21 (-8.68 to 11.77)2.13 (-5.75 to 9.48)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.5443
SecondaryPercent Change From Baseline to Week 12 in Non-HDL-C
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Non-HDL-C
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Non-HDL-C-16.07 (-31.98 to 0.73)0.81 (-17.14 to 22.65)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann Method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Total Cholesterol
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Total Cholesterol
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Total Cholesterol-11.26 (-24.95 to 3.40)1.55 (-13.17 to 19.84)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in LDL-C
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in LDL-C
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in LDL-C31.93 (0.84 to 78.12)1.01 (-19.83 to 26.41)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
Time frame:
12 Weeks
Reported as:
Median · Percent Chage
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
Percent ChageK-877Placebo
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)-19.07 (-41.64 to 14.10)10.29 (-22.61 to 71.16)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Apo A2
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo A2
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo A215.30 (0.32 to 27.06)2.89 (-5.99 to 9.71)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Apo B
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo B
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo B2.41 (-12.71 to 19.36)3.73 (-9.09 to 17.51)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.4939
SecondaryPercent Change From Baseline to Week 12 in Apo B48
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo B48
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo B48-31.35 (-64.59 to 33.65)22.62 (-38.27 to 138.37)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Apo B100
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo B100
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo B1003.09 (-12.20 to 20.48)2.76 (-11.55 to 17.15)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.8371
SecondaryPercent Change From Baseline to Week 12 in Apo C2
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo C2
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo C20.00 (-25.01 to 0.00)0.00 (-0.03 to 0.00)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.3415
SecondaryPercent Change From Baseline to Week 12 in Apo C3
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo C3
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo C3-39.56 (-54.84 to -16.27)5.11 (-17.61 to 36.39)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Apo E
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Apo E
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Apo E-28.48 (-43.33 to -3.58)0.56 (-18.21 to 37.20)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryChange From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
Time frame:
12 Weeks
Reported as:
Median · pg/mL
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
pg/mLK-877Placebo
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)196.97 (37.42 to 469.14)3.88 (-100.26 to 121.23)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryChange From Baseline to Week 12 in hsCRP
Time frame:
12 Weeks
Reported as:
Median · mg/L
Change From Baseline to Week 12 in hsCRP
mg/LK-877Placebo
Change From Baseline to Week 12 in hsCRP-0.051 (-1.491 to 0.743)-0.100 (-1.273 to 0.597)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.7442
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large-27.89 (-51.25 to -0.45)5.99 (-21.19 to 39.53)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate-17.32 (-37.38 to 5.09)4.70 (-18.69 to 28.96)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small-4.13 (-19.85 to 16.25)1.86 (-18.40 to 24.46)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0374
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 14.47 (-13.54 to 24.49)2.10 (-17.05 to 25.95)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.7429
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 215.50 (-0.61 to 44.88)3.06 (-14.55 to 24.51)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I45.24 (11.80 to 87.52)1.04 (-15.53 to 21.64)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa59.36 (17.64 to 112.28)0.75 (-16.59 to 22.46)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb61.87 (12.77 to 111.62)1.26 (-17.93 to 26.00)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa33.08 (-10.18 to 85.81)0.85 (-14.11 to 33.65)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb-1.50 (-41.65 to 52.99)1.11 (-19.55 to 29.73)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.3669
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa-24.88 (-56.93 to 7.48)-0.26 (-20.30 to 25.74)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb-34.81 (-53.95 to -12.17)5.60 (-19.62 to 32.04)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc-21.68 (-39.22 to -4.57)4.65 (-14.87 to 24.95)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b-7.34 (-19.80 to 3.85)2.04 (-10.69 to 15.52)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a-2.01 (-13.44 to 9.82)1.76 (-9.43 to 11.91)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0509
SecondaryPercent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Ion Mobility - Major LDL Particle Measurement2.38 (0.74 to 4.31)-0.06 (-0.97 to 0.84)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-37.93 (-60.09 to -7.54)5.37 (-23.57 to 53.56)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large-48.58 (-73.96 to -15.98)7.54 (-35.11 to 103.86)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium
Time frame:
12 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium
nmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Medium-33.57 (-72.83 to 0.59)7.58 (-33.08 to 47.63)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
Time frame:
12 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
nmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small0.90 (-13.53 to 18.10)-1.87 (-23.39 to 12.26)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0647
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
Time frame:
12 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
nmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)209.41 (-139.84 to 596.86)51.43 (-213.52 to 275.68)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0007
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
Time frame:
12 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
nmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles-5.52 (-109.19 to 49.33)-0.21 (-98.28 to 102.41)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.1399
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
Time frame:
12 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
nmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large27.54 (0.00 to 256.61)0.00 (0.00 to 39.76)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0122
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
Time frame:
12 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
nmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small87.75 (-254.51 to 468.78)23.85 (-200.74 to 297.25)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0994
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)2.87 (-9.72 to 17.11)-1.07 (-12.86 to 13.72)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0904
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
Time frame:
12 Weeks
Reported as:
Median · μmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
μmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large0.27 (-0.94 to 1.45)0.05 (-1.28 to 1.43)
Statistical analysis
  • K-877 vs Placebo · non-parametric Hodges-Lehmann method · p = 0.4346
SecondaryChange From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
Time frame:
12 Weeks
Reported as:
Median · μmol/L
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
μmol/LK-877Placebo
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium-0.97 (-4.31 to 2.65)0.02 (-3.32 to 2.74)
Statistical analysis
  • K-877 vs Placebo · non-parametric Hodges-Lehmann method · p = 0.1474
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small7.08 (-14.34 to 32.08)-2.42 (-18.72 to 17.47)
Statistical analysis
  • K-877 vs Placebo · non-parametric Hodges-Lehmann method · p = 0.0054
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size-5.70 (-14.70 to 5.21)0.80 (-10.18 to 12.05)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0002
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size1.00 (0.00 to 3.26)0.01 (-0.51 to 1.00)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size-1.14 (-4.44 to 2.07)0.00 (-2.89 to 3.36)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.0118
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)-48.78 (-69.80 to -18.51)8.43 (-28.90 to 70.31)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride-49.06 (-70.30 to -20.13)6.71 (-28.59 to 70.18)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <.0001
SecondaryPercent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Cholesterol-0.11 (-19.62 to 22.54)-4.63 (-18.43 to 13.68)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.2049
SecondaryPercent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C-62.64 (-79.05 to -34.09)-11.22 (-49.07 to 57.86)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C-25.84 (-42.29 to -4.77)-3.86 (-22.83 to 19.87)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C-30.79 (-47.69 to -5.64)-4.49 (-25.49 to 23.46)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B30.90 (7.30 to 62.27)-0.49 (-21.23 to 18.79)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A10.73 (-15.39 to 20.43)2.47 (-11.55 to 14.60)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = 0.9117
SecondaryPercent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time frame:
12 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Percent ChangeK-877Placebo
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2-24.84 (-44.79 to -3.68)7.50 (-13.29 to 35.11)
Statistical analysis
  • K-877 vs Placebo · Hodges-Lehmann method · p = <0.0001
SecondaryPercent Change From Baseline to Week 52 in Fasting TG
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Fasting TG
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Fasting TG-57.93 (-73.76 to -31.97)-55.45 (-68.95 to -28.74)
SecondaryPercent Change From Baseline to Week 52 in Remnant Cholesterol
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Remnant Cholesterol
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Remnant Cholesterol-53.98 (-70.63 to -26.55)-49.11 (-67.45 to -21.35)
SecondaryPercent Change From Baseline to Week 52 in HDL-C
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in HDL-C
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in HDL-C17.65 (-1.27 to 39.29)19.35 (3.03 to 38.89)
SecondaryPercent Change From Baseline to Week 52 in Apo A1
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo A1
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo A11.63 (-8.59 to 10.42)3.48 (-3.42 to 10.92)
SecondaryPercent Change From Baseline to Week 52 in Non-HDL-C
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Non-HDL-C
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Non-HDL-C-17.24 (-32.00 to 0.00)-15.71 (-29.85 to 0.63)
SecondaryPercent Change From Baseline to Week 52 in TC
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in TC
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in TC-11.84 (-25.37 to 1.61)-9.93 (-23.08 to 3.21)
SecondaryPercent Change From Baseline to Week 52 in LDL-C
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in LDL-C
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in LDL-C31.15 (2.04 to 70.59)36.84 (1.38 to 78.29)
SecondaryPercent Change From Baseline to Week 52 in FFAs
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in FFAs
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in FFAs-18.08 (-40.81 to 18.60)-13.64 (-38.15 to 13.91)
SecondaryPercent Change From Baseline to Week 52 in Apo A2
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo A2
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo A29.26 (-2.44 to 22.58)12.31 (0.00 to 22.58)
SecondaryPercent Change From Baseline to Week 52 in Apo B
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo B
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo B0.93 (-12.65 to 19.85)2.46 (-12.68 to 17.00)
SecondaryPercent Change From Baseline to Week 52 in Apo B48
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo B48
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo B48-14.04 (-56.90 to 68.32)-5.22 (-48.40 to 84.46)
SecondaryPercent Change From Baseline to Week 52 in Apo B100
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo B100
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo B1001.48 (-13.93 to 19.77)1.97 (-12.66 to 17.23)
SecondaryPercent Change From Baseline to Week 52 in Apo C2
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo C2
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo C2-8.70 (-30.60 to 0.00)-1.80 (-24.20 to 0.00)
SecondaryPercent Change From Baseline to Week 52 in Apo C3
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo C3
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo C3-36.70 (-58.82 to -15.25)-30.77 (-51.65 to -5.91)
SecondaryPercent Change From Baseline to Week 52 in Apo E
Time frame:
52 Weeks
Reported as:
Median · Percent of Change
Percent Change From Baseline to Week 52 in Apo E
Percent of ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Apo E-29.94 (-47.16 to -10.64)-30.67 (-44.60 to -4.44)
SecondaryChange From Baseline to Week 52 in FGF21
Time frame:
52 Weeks
Reported as:
Median · pg/mL
Change From Baseline to Week 52 in FGF21
pg/mLK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in FGF21259.20 (16.10 to 545.65)207.50 (53.70 to 499.90)
SecondaryChange From Baseline to Week 52 in hsCRP
Time frame:
52 Weeks
Reported as:
Median · mg/L
Change From Baseline to Week 52 in hsCRP
mg/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in hsCRP0.000 (-1.000 to 1.400)-0.200 (-1.320 to 0.400)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large-33.43 (-53.96 to 5.54)-24.44 (-46.64 to 4.31)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate-21.71 (-40.18 to 11.94)-11.70 (-32.94 to 10.50)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small-4.28 (-22.23 to 17.29)-3.23 (-18.03 to 28.03)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 14.44 (-12.86 to 25.81)8.23 (-15.88 to 37.67)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 221.05 (2.32 to 48.91)21.09 (-4.00 to 51.00)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I48.52 (17.51 to 95.70)38.99 (9.07 to 82.58)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa64.54 (21.24 to 120.44)44.52 (8.87 to 113.47)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb58.07 (14.25 to 122.86)42.18 (8.41 to 102.42)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa31.63 (-7.19 to 75.36)30.84 (-3.26 to 86.03)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb0.34 (-42.86 to 42.90)4.31 (-23.03 to 45.81)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa-24.86 (-55.96 to 10.11)-15.38 (-48.48 to 13.31)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb-35.58 (-52.93 to -11.22)-27.86 (-50.00 to -2.41)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc-24.00 (-36.55 to -6.88)-22.02 (-35.80 to -3.57)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b-9.54 (-18.19 to 2.06)-8.99 (-19.00 to 1.5)
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a-3.58 (-12.59 to 6.5)-3.06 (-12.33 to 6.09)
SecondaryPercent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Ion Mobility - Diameter of the Major LDL Particle2.38 (0.55 to 4.69)1.56 (0.39 to 3.37)
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-39.09 (-59.18 to -7.46)-30.29 (-53.45 to 2.58)
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles-Large-51.64 (-75.46 to -10.20)-51.23 (-70.89 to 2.75)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium
Time frame:
52 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium
nmol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Medium-34.20 (-71.10 to -1.20)-20.70 (-70.4 to 15.00)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
Time frame:
52 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
nmol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small0.00 (-19.00 to 19.40)3.85 (-21.90 to 21.80)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
Time frame:
52 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
nmol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)193.00 (-115.00 to 533.00)213.50 (-97.00 to 572.00)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
Time frame:
52 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
nmol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles-9.00 (-101.00 to 48.00)-6.50 (-133.00 to 75.00)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
Time frame:
52 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
nmol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large25.50 (0.00 to 280.00)50.50 (0.00 to 215.00)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
Time frame:
52 Weeks
Reported as:
Median · nmol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
nmol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small81.00 (-222.00 to 420.00)138.00 (-187.00 to 436.00)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles1.07 (-11.50 to 15.46)1.38 (-12.57 to 12.45)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
Time frame:
52 Weeks
Reported as:
Median · umol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
umol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large0.10 (-1.20 to 1.40)-0.10 (-1.20 to 1.20)
SecondaryChange From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
Time frame:
52 Weeks
Reported as:
Median · umol/L
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
umol/LK-877Placebo/Fenofibrate
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium-0.80 (-4.80 to 2.10)-1.15 (-4.10 to 2.00)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small9.01 (-11.19 to 32.20)6.37 (-12.50 to 30.46)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size-6.12 (-16.22 to 5.41)-6.70 (-16.08 to 5.51)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size0.99 (0.00 to 3.08)0.51 (0.00 to 2.54)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size-1.15 (-4.49 to 2.33)-1.11 (-3.49 to 2.33)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride-48.01 (-70.62 to -22.77)-48.29 (-65.74 to -7.86)
SecondaryPercent 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
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride-48.38 (-71.40 to -24.22)-47.69 (-65.55 to -7.72)
SecondaryPercent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Cholesterol-3.88 (-18.74 to 22.40)-2.63 (-17.24 to 12.90)
SecondaryPercent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C-63.46 (-80.92 to -32.83)-65.21 (-77.40 to -38.31)
SecondaryPercent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C-27.21 (-42.91 to -6.46)-27.59 (-41.20 to -6.65)
SecondaryPercent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C-30.63 (-48.39 to -7.52)-32.36 (-46.88 to -8.11)
SecondaryPercent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B28.03 (6.73 to 57.69)24.73 (2.50 to 60.32)
SecondaryPercent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A11.05 (-16.67 to 18.46)-1.76 (-13.04 to 14.58)
SecondaryPercent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time frame:
52 Weeks
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Percent ChangeK-877Placebo/Fenofibrate
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2-20.98 (-40.38 to -0.74)-13.99 (-37.76 to 6.76)

Adverse events

Collected over 52 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
K-877: 12-Week Efficacy0/368 (0%)13/368 (3.5%)3/368 (0.8%)
Placebo: 12-Week Efficacy0/183 (0%)5/183 (2.7%)2/183 (1.1%)
K-877 and Fenofibrate Placebo: 40-Week Extension3/350 (0.9%)17/350 (4.9%)9/350 (2.6%)
Fenofibrate and K-877 Placebo: 40-Week Extension0/177 (0%)3/177 (1.7%)9/177 (5.1%)
Most frequent serious events
Showing 10 of 41
Most frequent serious events
EventK-877: 12-Week EfficacyPlacebo: 12-Week EfficacyK-877 and Fenofibrate Placebo: 40-Week ExtensionFenofibrate and K-877 Placebo: 40-Week Extension
Diabetes mellitus inadequate controlMetabolism and nutrition disorders0/3680/1832/3500/177
Angina unstableCardiac disorders2/3681/1831/3501/177
Gastrointestinal inflammationGastrointestinal disorders0/3680/1830/3501/177
DepressionPsychiatric disorders0/3680/1830/3501/177
Coronary artery diseaseCardiac disorders1/3681/1831/3500/177
Visual impairmentEye disorders0/3681/1830/3500/177
Glomerulonephritis chronicRenal and urinary disorders0/3681/1830/3500/177
Toxic skin eruptionSkin and subcutaneous tissue disorders0/3681/1830/3500/177
Peripheral ischaemiaVascular disorders0/3681/1830/3500/177
Acute myocardial infarctionCardiac disorders0/3680/1831/3500/177
Most frequent other events
Most frequent other events
EventK-877: 12-Week EfficacyPlacebo: 12-Week EfficacyK-877 and Fenofibrate Placebo: 40-Week ExtensionFenofibrate and K-877 Placebo: 40-Week Extension
NasopharyngitisInfections and infestations3/3682/1839/3509/177

Baseline characteristics

Age, Customized
Age, Customized(Participants)K-877Placebo/FenofibrateTotal
Age (Years) — <65351176527
Age (Years) — ≥6517724
Sex: Female, Male
Sex: Female, Male(Participants)K-877Placebo/FenofibrateTotal
Female9739136
Male271144415
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)K-877Placebo/FenofibrateTotal
Hispanic or Latino27835
Not Hispanic or Latino341175516
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)K-877Placebo/FenofibrateTotal
American Indian or Alaska Native101
Asian325
Native Hawaiian or Other Pacific Islander202
Black or African American404
White358180538
More than one race000
Unknown or Not Reported011
Triglycerides
Triglycerides(mg/dL)K-877Placebo/FenofibrateTotal
Mean810.98 ± 369.284819.25 ± 414.722813.73 ± 384.611
08

Study locations

220 sites
  • Central Research Associates, Inc.
    Birmingham, Alabama 35205, United States
  • Central Alabama Research
    Birmingham, Alabama 35209, United States
  • Cahaba Research, Inc.
    Birmingham, Alabama 35242, United States
  • Boyett Health Services Inc
    Hamilton, Alabama 35570, United States
  • Longwood Research - Saadat Ansari, MD, LLC
    Huntsville, Alabama 35801, United States
  • Terence T. Hart, MD
    Tuscumbia, Alabama 35674, United States
  • Arrowhead Health Centers
    Glendale, Arizona 85306, United States
  • Phoenix Medical Research Institute, LLC
    Peoria, Arizona 85381, United States
  • Elite Clinical Studies
    Phoenix, Arizona 85018, United States
  • Clinical Research Institute of Arizona, LLC
    Surprise, Arizona 85374, United States
  • iResearch - Little Rock
    Little Rock, Arkansas 72205, United States
  • Lynn Institute of the Ozarks
    Little Rock, Arkansas 72205, United States
  • Advanced Research Center
    Anaheim, California 92805, United States
  • Torrance Clinical Research Institute Inc.
    Lomita, California 90717, United States
  • Downtown L.A. Research Center, Inc.
    Los Angeles, California 90017, United States
  • Catalina Research Institute, LLC
    Montclair, California 91763, United States
  • Lucita M. Cruz, MD., Inc.
    Norwalk, California 90650, United States
  • Creekside Endocrine Associates, PC
    Denver, Colorado 80246, United States
  • Atlantic Clinical Research Collaborative
    Boynton Beach, Florida 33472, United States
  • ALL Medical Research, LLC
    Cooper City, Florida 33024, United States
  • S & W Clinical Research
    Fort Lauderdale, Florida 33306, United States
  • Indago Research and Health Center
    Hialeah, Florida 33012, United States
  • Jacksonville Impotence Treatment Center
    Jacksonville, Florida 32223, United States
  • AMPM Research Clinic
    Miami Gardens, Florida 33169, United States
  • Advanced Research Institute Inc
    New Port Richey, Florida 34653, United States
  • Ocala Cardiovascular Research
    Ocala, Florida 34474, United States
  • South Florida Research Solutions LLC. - Pembroke Pines
    Pembroke Pines, Florida 33029, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Cardiovascular Center of Sarasota
    Sarasota, Florida 34239, United States
  • Meridien Research - Tampa
    Tampa, Florida 33634, United States
  • Columbus Regional Health
    Columbus, Georgia 31904, United States
  • Physicians Research Associates, Inc
    Lawrenceville, Georgia 30046, United States
  • Georgia Institute for Clinical Research
    Marietta, Georgia 30060, United States
  • Meridian Clinical Research - Savannah, GA
    Savannah, Georgia 31406, United States
  • Solaris Clinical Research
    Meridian, Idaho 83646, United States
  • Apex Medical Research - Illinois
    Chicago, Illinois 60616, United States
  • Lemah Creek Clinical Research
    Melrose Park, Illinois 60160, United States
  • Koch Family Medicine
    Morton, Illinois 61550, United States
  • Community Hospital of Anderson and Madison County, Inc
    Anderson, Indiana 46011, United States
  • American Health Network - Avon Clinical Research Department
    Avon, Indiana 46103, United States
  • Medisphere Medical Research Center
    Evansville, Indiana 47714, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Buynak Clinical Research, P.C.
    Valparaiso, Indiana 46383, United States
  • West Broadway Clinic
    Council Bluffs, Iowa 51501, United States
  • The Iowa Clinic - Cardiovascular Services
    West Des Moines, Iowa 50266, United States
  • Professional Research Network of Kansas, LLC
    Wichita, Kansas 67205-1138, United States
  • The Research Group of Lexington, LLC
    Lexington, Kentucky 40503, United States
  • Research Integrity LLC
    Owensboro, Kentucky 42303, United States
  • Clinical Trials Management, LLC - Northshore
    Covington, Louisiana 70443, United States
  • Clinical Trials Management LLC - Southshore
    Metairie, Louisiana 70006, United States
  • Clinical Trials of America, LLC - West Monroe, LA
    West Monroe, Louisiana 71291, United States
  • Maryland Cardiovascular Specialist
    Baltimore, Maryland 21229, United States
  • Aa Mrc, Llc
    Flint, Michigan 48504, United States
  • Oakland Medical Research Center
    Troy, Michigan 48085, United States
  • David M. Headley, MD P.A.
    Port Gibson, Mississippi 39150, United States
  • Consult and Research Associates
    Saint Louis, Missouri 63122, United States
  • Advance Clinical Research, Inc
    Saint Louis, Missouri 63128, United States
  • Glacier View Research Institute
    Kalispell, Montana 59901, United States
  • Desert Endocrinology Clinical Research Center - Henderson
    Henderson, Nevada 89052, United States
  • Palm Research Center, Inc.
    Las Vegas, Nevada 89148, United States
  • Lovelace Scientific Resources
    Albuquerque, New Mexico 87108, United States
  • Lakeshore Primary Care Associate
    Hamburg, New York 14075, United States
  • Mid-Hudson Medical Research, PLLC - Hopewell Junction
    New Windsor, New York 12553, United States
  • Mid-Hudson Medical Research, PLLC - New Windsor
    New Windsor, New York 12553, United States
  • Orchard Park Family Practice
    Orchard Park, New York 14127, United States
  • Diabetes and Endocrinology Consultants, P.C.
    Morehead City, North Carolina 28557, United States
  • Lillestol Research, LLC
    Fargo, North Dakota 58104, United States
  • Sterling Research Group, Ltd. - Auburn
    Cincinnati, Ohio 45219, United States
  • Aventiv Research, Inc.
    Columbus, Ohio 43213, United States
  • Alpha Research Associates, LLC
    Dayton, Ohio 45417, United States
  • Prestige Clinical Research
    Franklin, Ohio 45005, United States
  • Ohio Clinical Research - Lyndhurst
    Lyndhurst, Ohio 44124, United States
  • Rama Research LLC
    Marion, Ohio 43302, United States
  • RAS Health Ltd
    Marion, Ohio 43302, United States
  • Summit Research Group, LLC
    Munroe Falls, Ohio 44262, United States
  • Ohio Clinical Research, LLC - Willoughby Hills
    Willoughby Hills, Ohio 44094, United States
  • South Oklahoma Heart Research
    Oklahoma City, Oklahoma 73135, United States
  • Clinical Research Associates of Central PA, LLC
    Altoona, Pennsylvania 16602, United States
  • Harleysville Medical Associates
    Harleysville, Pennsylvania 19438, United States
  • Richard M.Kastelic MD and Associates
    Johnstown, Pennsylvania 15905, United States
  • Green and Seidner Family Practice Associates
    Lansdale, Pennsylvania 19446, United States
  • Center for Medical Research, LLC
    Providence, Rhode Island 02908, United States
  • DeGarmo Institute Of Medical Research
    Greer, South Carolina 29650, United States
  • Health Concepts
    Rapid City, South Dakota 57702, United States
  • PMG Research of Bristol, LLC - State
    Bristol, Tennessee 37620, United States
  • New Phase Research & Development - Knoxville
    Knoxville, Tennessee 37909, United States
  • Clinical Research Solutions - Smyrna, TN
    Smyrna, Tennessee 37167, United States
  • Health Innovation Research Group
    Arlington, Texas 76014, United States
  • DCT-AACT, LLC, dba Discovery Clinical Trials
    Austin, Texas 78758, United States
  • Inquest Clinical Research
    Baytown, Texas 77521, United States
  • Protenium Clinical Research, LLC - Dallas
    Dallas, Texas 75208, United States
  • VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)
    Dallas, Texas 75216, United States
  • Academy of Diabetes, Thyroid and Endocrine, P.A.
    El Paso, Texas 79935, United States
  • Juno Research, LLC - Northwest Site
    Houston, Texas 77040, United States
  • Centex Studies, Inc.
    Houston, Texas 77058, United States
  • Juno Research, LLC - Southwest Houston Site
    Houston, Texas 77074, United States
  • Pioneer Research Solutions Inc.
    Houston, Texas 77099, United States
  • Grace Research, LLC - Huntsville, TX
    Huntsville, Texas 77340, United States
  • Protenium Clinical Research, LLC
    Hurst, Texas 76054, United States
  • Juno Research, LLC - Katy
    Katy, Texas 77450, United States

Showing the first 100 of 220 sites across 9 countries.

09

References and documents

Study documents

  • Study protocol · Sep 13, 2016
  • Study protocol · Aug 18, 2017
  • Statistical analysis plan · Oct 19, 2016
  • Statistical analysis plan · Jun 21, 2019
  • Statistical analysis plan · Oct 21, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03001817
Lead sponsor
Kowa Research Institute, Inc.
Responsible party
Sponsor
First posted
Dec 23, 2016
Start date
Nov 28, 2016
Primary completion
Jun 24, 2019
Completion
Jun 24, 2019
Results posted
Nov 30, 2022
Last update
Nov 30, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

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Other studies from this sponsor

Kowa Research Institute, Inc.

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