Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.

Study Overview

• Status: Completed
• Conditions: Severe Hypertriglyceridemia
• Intervention / Treatment: Drug: Fenofibrate; Drug: K-877; Drug: Placebo (for K-877)

• Study Type: Interventional
• Enrollment (Actual): 471
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Brest, Belarus, 224027
    • Brest Regional Hospital
  • Gomel, Belarus, 246029
    • Gomel Regional Clinical Hospital
  • Gomel, Belarus, 246046
    • Gomel Regional Clinical Center of Cardiology
  • Grodno, Belarus, 230030
    • Grodno University Hospital
  • Minsk, Belarus, 220013
    • City Clinical Hospital #1
  • Minsk, Belarus, 223041
    • Minsk Regional Clinical Hospital
  • Minsk, Belarus, 220045
    • City Clinical Hospital #9
  • Minsk, Belarus, 220045
    • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
  • Minsk, Belarus, 220096
    • City Clinical Hospital #10
  • Mogilev, Belarus, 212030
    • Mogilev Regional Medical and Diagnostic Center
  • Vitebsk, Belarus, 210037
    • Vitebsk Regional Clinical Hospital
• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Medical Center Diamedical 2013 OOD
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - Clinic of Cardiology
  • Smolyan, Bulgaria, 4700
    • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
  • Smolyan, Bulgaria, 4700
    • MHAT Dr. Bratan Shukjerov
  • Sofia, Bulgaria, 1233
    • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology
  • Sofia, Bulgaria, 1233
    • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases
  • Stara Zagora, Bulgaria, 6000
    • Medical Center Orfey OOD
• Czechia
  • Brandýs nad Labem, Czechia, 250 01
    • Medicus Services sro
  • Bílina, Czechia, 41801
    • Lipidova poradna
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka
  • Praha 10, Czechia, 101 00
    • Ordinace pro choroby srdce a cev
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Praha 5, Czechia, 15006
    • Fakultni nemocnice v Motole
  • Trutnov, Czechia, 541 21
    • Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie
  • Uherské Hradište, Czechia, 68601
    • MUDr. Nina Zemkova s.r.o. Interni Ambulance
• Georgia
  • Batumi, Georgia, 6010
    • Unimed Ajara LLC
  • Kutaisi, Georgia, 4600
    • Clinic LJ Ltd
  • Tbilisi, Georgia, 102
    • Aleksandre Aladashvili Clinic - LLC
  • Tbilisi, Georgia, 159
    • Archangel St Michael Multiprofile Clinical Hospital Ltd
  • Tbilisi, Georgia, 159
    • Emergency Cardiology Center by Academician G. Chapidze Ltd
  • Tbilisi, Georgia, 159
    • Institute of Clinical Cardiology Ltd
  • Tbilisi, Georgia, 159
    • Unimed Kakheti - Caraps Medline LLC
  • Telavi, Georgia, 2200
    • Unimed Kakheti - Telavi Referral Hospital LLC
• Hungary
  • Balatonfüred, Hungary, H-8230
    • DRC Gyogyszervizsgalo Kozpont Kft
  • Balatongyörök, Hungary, H-8313
    • DRC Balatongyorok
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
  • Budapest, Hungary, 1134
    • Magyar Honvédség Egészségügyi Központ
  • Békéscsaba, Hungary, 5600
    • Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
  • Debrecen, Hungary, H-4032
    • Debreceni Egyetem Klinikai Kozpont
  • Hatvan, Hungary, 3000
    • BKS Research Kft.
  • Pécs, Hungary, 7624
    • Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
  • Székesfehérvár, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Poland
  • Gdynia, Poland, 81-157
    • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
  • Katowice, Poland, 40-772
    • SALVIA Lekston i Madej s.j.
  • Krakow, Poland, 31-534
    • Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O
  • Oświęcim, Poland, 32-600
    • Medicome Sp. z o.o.
  • Poznań, Poland, 61-655
    • Praktyka Lekarska Ewa Krzyzagorska
  • Poznań, Poland, 60-589
    • Centrum Zdrowia Metabolicznego Pawel Bogdanski
  • Płock, Poland, 09-400
    • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
  • Skierniewice, Poland, 96-100
    • Clinmedica Research Omc Sp z o.o. Sp
  • Wrocław, Poland, 50-315
    • Centrum Kardiologiczne Pro Corde Sp. z o. o.
  • Łódź, Poland, 90-349
    • AppleTreeClinics Sp. z o.o.
  • Łódź, Poland, 94-048
    • NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
  • Łódź, Poland, 91 302
    • Nzoz Salusmed
• Russian Federation
  • Arkhangelsk, Russian Federation, 163000
    • Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
  • Arkhangelsk, Russian Federation, 163001
    • First City Clinical Hospital n.a. E.E.Volosevich
  • Barnaul, Russian Federation, 656055
    • Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction
  • Chita, Russian Federation, 672000
    • Chita State Medical Academy
  • Ekaterinburg, Russian Federation, 620028
    • Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District
  • Kazan, Russian Federation, 420101
    • Interregional Clinical Diagnostic Center
  • Kazan, Russian Federation, 420103
    • Kazan State Medical University based at City Clinical Hospital #7
  • Kemerovo, Russian Federation, 650002
    • Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases
  • Kirovsk, Russian Federation, 187342
    • Medical Center Alliance
  • Krasnoyarsk, Russian Federation, 660062
    • Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky
  • Moscow, Russian Federation, 101990
    • National Medical Research Center of Preventive Medicine
  • Moscow, Russian Federation, 111539
    • City Clinical Hospital #15 n.a. O.M. Filatov
  • Moscow, Russian Federation, 117593
    • Central Clinical Hospital of Russian Academy of Sciences
  • Moscow, Russian Federation, 121374
    • City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department
  • Moscow, Russian Federation, 121552
    • National Medical Research Center of Cardiology - Department of Atherosclerosis
  • Moscow, Russian Federation, 121552
    • National Medical Research Center of Cardiology
  • Moscow, Russian Federation, 124489
    • City Clinical Hospital n.a. M.P. Konchalovskiy
  • Moscow, Russian Federation, 125315
    • Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
  • Moscow, Russian Federation, 129090
    • Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
  • Novosibirsk, Russian Federation, 630051
    • City Clinical Hospital No.2
  • Novosibirsk, Russian Federation, 630091
    • RC Medical LLC
  • Novosibirsk, Russian Federation, 630117
    • Research Institute of Physiology and Fundamental Medicine
  • Orenburg, Russian Federation, 460000
    • Orenburg State Medical University based at City Clinical Hospital #1
  • Rostov-on-Don, Russian Federation, 344011
    • Clinical-diagnostic center Zdorovye
  • Rostov-on-Don, Russian Federation, 344068
    • Rostov-on-Don City Hospital of Emergency Care
  • Saint Petersburg, Russian Federation, 191015
    • North-Western State Medical University named after I.I. Mechnikov
  • Saint Petersburg, Russian Federation, 194356
    • Limited Liability Company MedPomosch
  • Saint Petersburg, Russian Federation, 190013
    • Clinic Complex JSC
  • Saint Petersburg, Russian Federation, 191025
    • Medical Technologies LLC
  • Saint Petersburg, Russian Federation, 196601
    • City hospital #38 n.a. N.A. Semashko
  • Saint Petersburg, Russian Federation, 197022
    • BioTechService LLC
  • Saint Petersburg, Russian Federation, 197110
    • Consultative Diagnostic Center with Out-patient Clinic
  • Saint Petersburg, Russian Federation, 197341
    • Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
  • Saint Petersburg, Russian Federation, 199106
    • Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Department of Cardiology N.3
  • Saratov, Russian Federation, 410028
    • Regional clinical cardiology dispensary
  • Saratov, Russian Federation, 410054
    • Saratov State Medical University n. a. V.I. Razumovsky
  • St. Petersburg, Russian Federation, 194156
    • Almazov National Medical Research Centre
  • St. Petersburg, Russian Federation, 194291
    • Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency
  • Tomsk, Russian Federation, 634012
    • Tomsk National Research Medical Center of Russian Academy of Sciences
  • Voronezh, Russian Federation, 394018
    • Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre
  • Yaroslavl, Russian Federation, 150047
    • Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"
• Ukraine
  • Ivano-Frankivs'k, Ukraine, 76018
    • Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
  • Kharkiv, Ukraine, 61002
    • Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department
  • Kharkiv, Ukraine, 61103
    • Kharkiv Medical Academy of Postgraduate Education
  • Kharkiv, Ukraine, 61103
    • Kharkiv Railway Clinic. Hosp.#1, Branch Office of "Healthcare Center" of PJSC "Ukr. Railways", Cardiology Depart #2
  • Kharkiv, Ukraine, 61103
    • Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1
  • Kharkiv, Ukraine, 61103
    • Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov of Kharkiv City Council
  • Kharkiv, Ukraine, 61172
    • Municipal Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1
  • Kyiv, Ukraine, 2002
    • Limited Liability Company Treatment and Diagnostic Center Adonis Plus, Outpatient Department
  • Kyiv, Ukraine, 2091
    • Kyiv City Clinical Hospital #1, Urgent Cardiology Department
  • Kyiv, Ukraine, 4114
    • SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t., Gen. Ther.Unit
  • Kyiv, Ukraine, 4114
    • SI Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine, Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t
  • Odesa, Ukraine, 65014
    • Municipal Institution City Clinical Hospital #3 n.a. prof. L.J. Aleinikova, Cardiology Intensive Therapy Department
  • Vinnytsya, Ukraine, 21001
    • Small Private Enterprise, Medical Centre Puls
  • Zaporizhzhia, Ukraine, 69035
    • Municipal Institution City Clinical Hospital #6, Therapeutic Department
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research, Inc.
    • Hamilton, Alabama, United States, 35570
      • Boyett Health Services Inc
    • Huntsville, Alabama, United States, 35801
      • Longwood Research - Saadat Ansari, MD, LLC
    • Tuscumbia, Alabama, United States, 35674
      • Terence T. Hart, MD
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arrowhead Health Centers
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Research Institute, LLC
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies
    • Surprise, Arizona, United States, 85374
      • Clinical Research Institute of Arizona, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72205
      • IResearch
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute Inc.
    • Los Angeles, California, United States, 90017
      • Downtown L.A. Research Center, Inc.
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC
    • Newport Beach, California, United States, 92663
      • Pacific Coast Cardiology and Research
    • Norwalk, California, United States, 90650
      • Lucita M. Cruz, MD., Inc.
    • San Diego, California, United States, 92117
      • Integrated Research Center
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
  • Colorado
    • Denver, Colorado, United States, 80246
      • Creekside Endocrine Associates, PC
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Atlantic Clinical Research Collaborative
    • Cooper City, Florida, United States, 33024
      • ALL Medical Research, LLC
    • Fort Lauderdale, Florida, United States, 33306
      • S & W Clinical Research
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
    • Jacksonville, Florida, United States, 32223
      • Jacksonville Impotence Treatment Center
    • Miami Gardens, Florida, United States, 33169
      • AMPM Research Clinic
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute Inc
    • Ocala, Florida, United States, 34474
      • Ocala Cardiovascular Research
    • Pembroke Pines, Florida, United States, 33029
      • South Florida Research Solutions LLC.
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Sarasota, Florida, United States, 34239
      • Cardiovascular Center of Sarasota
    • Tampa, Florida, United States, 33634
      • Meridien Research
    • Tampa, Florida, United States, 33634
      • Meridien Research - Tampa
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Health
    • Decatur, Georgia, United States, 30030
      • IResearch
    • Lawrenceville, Georgia, United States, 30046
      • Physicians Research Associates, Inc
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions, Inc
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research - Savannah, GA
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Lemah Creek Clinical Research
    • Chicago, Illinois, United States, 60616
      • Apex Medical Research
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
    • Morton, Illinois, United States, 61550
      • Koch Family Medicine
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Hospital of Anderson and Madison County, Inc
    • Avon, Indiana, United States, 46103
      • American Health Network - Avon Clinical Research Department
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
    • Valparaiso, Indiana, United States, 46383
      • Buynak Clinical Research, P.C.
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • West Broadway Clinic
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic - Cardiovascular Services
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Professional Research Network of Kansas, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Kentucky Diabetes Endocrinology Center
    • Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington, LLC
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity LLC
  • Louisiana
    • Covington, Louisiana, United States, 70443
      • Clinical Trials Management, LLC - Northshore
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management LLC - Southshore
    • Shreveport, Louisiana, United States, 71105
      • Grace Research, LLC
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials of America, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Cardiovascular Specialists
  • Massachusetts
    • North Attleboro, Massachusetts, United States, 2760
      • Regeneris Medical
  • Michigan
    • Flint, Michigan, United States, 48504
      • Aa Mrc, Llc
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center
  • Mississippi
    • Port Gibson, Mississippi, United States, 39150
      • David M. Headley, MD P.A.
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Consult and Research Associates
    • Saint Louis, Missouri, United States, 63128
      • Advance Clinical Research, Inc
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Desert Endocrinology Clinical Research Center
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources
  • New York
    • Hamburg, New York, United States, 14075
      • Lakeshore Primary Care Associate
    • New Windsor, New York, United States, 12553
      • Mid-Hudson Medical Research, PLLC - Hopewell Junction
    • New Windsor, New York, United States, 12553
      • Mid-Hudson Medical Research, PLLC - New Windsor
    • Orchard Park, New York, United States, 14127
      • Orchard Park Family Practice
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Diabetes and Endocrinology Consultants, P.C.
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group, Ltd. - Auburn
    • Columbus, Ohio, United States, 43213
      • Aventiv Research, Inc.
    • Dayton, Ohio, United States, 45417
      • Alpha Research Associates, LLC
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Lyndhurst, Ohio, United States, 44124
      • Ohio Clinical Research - Lyndhurst
    • Marion, Ohio, United States, 43302
      • Rama Research LLC
    • Marion, Ohio, United States, 43302
      • RAS Health LTD
    • Munroe Falls, Ohio, United States, 44626
      • Summit Research Group, LLC
    • Willoughby Hills, Ohio, United States, 44094
      • Ohio Clinical Research, LLC - Willoughby Hills
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research
    • Oklahoma City, Oklahoma, United States, 73107
      • COR Clinical Research, LLC.
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Clinical Research Associates of Central PA, LLC
    • Harleysville, Pennsylvania, United States, 19438
      • Harleysville Medical Associates
    • Johnstown, Pennsylvania, United States, 15905
      • Richard M.Kastelic MD and Associates
    • Lansdale, Pennsylvania, United States, 19446
      • Green and Seidner Family Practice Associates
  • Rhode Island
    • Providence, Rhode Island, United States, 2908
      • Center for Medical Research, LLC
  • South Carolina
    • Anderson, South Carolina, United States, 29625
      • MD First Research
    • Anderson, South Carolina, United States, 29625
      • MDFirst Research - Anderson
    • Greer, South Carolina, United States, 29650
      • DeGarmo Institute of Medical Research
    • Lancaster, South Carolina, United States, 29720
      • MD First Research
    • Myrtle Beach, South Carolina, United States, 29588
      • Family Medicine of Sayebrook
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol, LLC - State
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Research & Medicine, PLLC
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
    • Smyrna, Tennessee, United States, 37167
      • Clinical Research Solutions - Smyrna, TN
  • Texas
    • Arlington, Texas, United States, 76014
      • Health Innovation Research Group
    • Austin, Texas, United States, 78758
      • DCT-AACT, LLC, dba Discovery Clinical Trials
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Corpus Christi, Texas, United States, 78404
      • Padre Coast Clinical Research
    • Dallas, Texas, United States, 75208
      • Protenium Clinical Research, LLC - Dallas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)
    • El Paso, Texas, United States, 79935
      • Academy of Diabetes, Thyroid and Endocrine, P.A.
    • Houston, Texas, United States, 77040
      • Juno Research, LLC
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77074
      • Juno Research, LLC
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions Inc.
    • Huntsville, Texas, United States, 77340
      • Grace Research, LLC
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research, LLC
    • Katy, Texas, United States, 77450
      • Juno Research, LLC
    • Lampasas, Texas, United States, 76550
      • FMC Science
    • Live Oak, Texas, United States, 78233
      • Pinnacle Clinical Research
    • McAllen, Texas, United States, 78503
      • DCT - McAllen Primary Care, LLC
    • San Antonio, Texas, United States, 78220
      • San Antonio Premier Internal Medicine
    • San Antonio, Texas, United States, 78228
      • Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
    • San Antonio, Texas, United States, 78249
      • Bandera Family HealthCare Research, LLC (BFHC)
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Norfolk, Virginia, United States, 23501
      • York Clinical Research LLC
    • Virginia Beach, Virginia, United States, 23454
      • Cardiovascular Associates, Ltd
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Exemplar Research Inc. - Fairmont, WV
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Allegiance Research Specialists, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
2. Aged ≥18 years;

3. Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):

   1. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
   2. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
   3. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
   4. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;

4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria;

   1. Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, 3.a. through 3.d.);
   2. Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or
   3. Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;

5. Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).

   • Mild to moderate renal impairment eGFR >= 30mL/min/1.73 and < 90 mL/min/1.73 at Visit 1

Exclusion Criteria:

1. Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
2. Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
3. Patients with type 1 diabetes mellitus;
4. Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1 (Week -8 or Week -6);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 12 Week Efficacy; K-877 or placebo comparator for 12 weeks	Drug: K-877; Drug: Placebo (for K-877)
Active Comparator: 40 week extension; K-877 or fenofibrate comparator for 40 weeks	Drug: Fenofibrate; Drug: K-877

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Fasting TG From Baseline to Week 12	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to Week 12 in Remnant Cholesterol		12 Weeks
Percent Change From Baseline to Week 12 in HDL-C		12 Weeks
Percent Change From Baseline to Week 12 in 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 Apo A2		12 Weeks
Percent Change From Baseline to Week 12 in Apo B		12 Weeks
Percent Change From Baseline to Week 12 in Apo B48		12 Weeks
Percent Change From Baseline to Week 12 in Apo B100		12 Weeks
Percent Change From Baseline to Week 12 in Apo C2		12 Weeks
Percent Change From Baseline to Week 12 in Apo C3		12 Weeks
Percent Change From Baseline to Week 12 in Apo E		12 Weeks
Change From Baseline to Week 12 in hsCRP		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 Apo B:Apo A1		12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2		12 Weeks
Percent Change From Baseline to Week 52 in Fasting TG		52 Weeks
Percent Change From Baseline to Week 52 in Remnant Cholesterol		52 Weeks
Percent Change From Baseline to Week 52 in HDL-C		52 Weeks
Percent Change From Baseline to Week 52 in Apo A1		52 Weeks
Percent Change From Baseline to Week 52 in Non-HDL-C		52 Weeks
Percent Change From Baseline to Week 52 in TC		52 Weeks
Percent Change From Baseline to Week 52 in LDL-C		52 Weeks
Percent Change From Baseline to Week 52 in FFAs		52 Weeks
Percent Change From Baseline to Week 52 in Apo A2		52 Weeks
Percent Change From Baseline to Week 52 in Apo B		52 Weeks
Percent Change From Baseline to Week 52 in Apo B48		52 Weeks
Percent Change From Baseline to Week 52 in Apo B100		52 Weeks
Percent Change From Baseline to Week 52 in Apo C2		52 Weeks
Percent Change From Baseline to Week 52 in Apo C3		52 Weeks
Percent Change From Baseline to Week 52 in Apo E		52 Weeks
Change From Baseline to Week 52 in FGF21		52 Weeks
Change From Baseline to Week 52 in hsCRP		52 Weeks
Percent Change From Baseline to Week 52 in 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 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
Percent Change From Baseline to Week 12 in FFAs		12 Weeks
Change From Baseline to Week 12 in FGF21		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b)		12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 3 and 2a)	Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.	12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å))		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Particles)	Two types of lipoprotein particles were analyzed together as one measurement without distinction.	12 Weeks
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.	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
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles)		12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles)		12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large)		12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small)		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles)		12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large)		12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium)		12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small)		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size)		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size)		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size)		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride)		12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)	Two types of lipoprotein particles were analyzed together as one measurement without distinction.	12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total)		12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C		12 Weeks
Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B		12 Weeks
Percent Change From Baseline to Week 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)	Two lipoprotein subclasses, HDL3 and HDL2a, were analyzed together as one measurement without distinction.	52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å))		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Particles)	Two types of lipoprotein particles were analyzed together as one measurement without distinction.	52 Weeks
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.	52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium)		52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride)		52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL & Chylomicron Triglyceride)	Two types of lipoprotein particles were analyzed together as one measurement without distinction.	52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol)		52 Weeks
Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B		52 Weeks

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2016
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): July 5, 2019

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: K-877-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No