AzTrials
AzTrials

Severe HypertriglyceridemiaPhase 3NCT03001817

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 study testing K-877 and Fenofibrate in people with Severe Hypertriglyceridemia, run by Kowa Research Institute, Inc. at 220 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Hypertriglyceridemia
What is being tested?
K-877 and Fenofibrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
551 participants
Where
220 sitesin 9 countries
Study dates
28 Nov 2016to 24 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
  • Aged ≥18 years;
  • 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):
  • 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);
  • 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);
  • 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
Show all 11Show fewer
  • 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;
  • Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria:
  • Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, criterion 3.a. through 3.d.);
  • 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
  • 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;

Who cannot join

  • 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;
  • Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
  • Patients with type 1 diabetes mellitus;
  • 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);

Trial locations and contacts

220 sites in 9 countries.

220 sites in 9 countries

United States110 sites

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Clinical Research Associates of Central PA, LLC

    Altoona, Pennsylvania, 16602

  • Advanced Research Center

    Anaheim, California, 92805

  • Community Hospital of Anderson and Madison County, Inc

    Anderson, Indiana, 46011

  • Health Innovation Research Group

    Arlington, Texas, 76014

  • DCT-AACT, LLC, dba Discovery Clinical Trials

    Austin, Texas, 78758

  • American Health Network - Avon Clinical Research Department

    Avon, Indiana, 46103

  • Maryland Cardiovascular Specialist

    Baltimore, Maryland, 21229

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Cahaba Research, Inc.

    Birmingham, Alabama, 35242

  • Atlantic Clinical Research Collaborative

    Boynton Beach, Florida, 33472

  • PMG Research of Bristol, LLC - State

    Bristol, Tennessee, 37620

  • Apex Medical Research - Illinois

    Chicago, Illinois, 60616

  • Sterling Research Group, Ltd. - Auburn

    Cincinnati, Ohio, 45219

  • Columbus Regional Health

    Columbus, Georgia, 31904

  • Aventiv Research, Inc.

    Columbus, Ohio, 43213

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • Clinical Trials Management, LLC - Northshore

    Covington, Louisiana, 70443

  • Protenium Clinical Research, LLC - Dallas

    Dallas, Texas, 75208

  • VA North Texas Health Care System - Dallas VA Medical Center (DVAMC)

    Dallas, Texas, 75216

  • Alpha Research Associates, LLC

    Dayton, Ohio, 45417

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80246

  • Academy of Diabetes, Thyroid and Endocrine, P.A.

    El Paso, Texas, 79935

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Aa Mrc, Llc

    Flint, Michigan, 48504

  • S & W Clinical Research

    Fort Lauderdale, Florida, 33306

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Arrowhead Health Centers

    Glendale, Arizona, 85306

  • DeGarmo Institute Of Medical Research

    Greer, South Carolina, 29650

  • Lakeshore Primary Care Associate

    Hamburg, New York, 14075

  • Boyett Health Services Inc

    Hamilton, Alabama, 35570

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Desert Endocrinology Clinical Research Center - Henderson

    Henderson, Nevada, 89052

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • Juno Research, LLC - Northwest Site

    Houston, Texas, 77040

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Juno Research, LLC - Southwest Houston Site

    Houston, Texas, 77074

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099

  • Longwood Research - Saadat Ansari, MD, LLC

    Huntsville, Alabama, 35801

  • Grace Research, LLC - Huntsville, TX

    Huntsville, Texas, 77340

  • Protenium Clinical Research, LLC

    Hurst, Texas, 76054

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Jacksonville Impotence Treatment Center

    Jacksonville, Florida, 32223

  • Richard M.Kastelic MD and Associates

    Johnstown, Pennsylvania, 15905

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Juno Research, LLC - Katy

    Katy, Texas, 77450

  • New Phase Research & Development - Knoxville

    Knoxville, Tennessee, 37909

  • FMC Science

    Lampasas, Texas, 76550

  • Green and Seidner Family Practice Associates

    Lansdale, Pennsylvania, 19446

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148

  • Physicians Research Associates, Inc

    Lawrenceville, Georgia, 30046

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • iResearch - Little Rock

    Little Rock, Arkansas, 72205

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

  • Ohio Clinical Research - Lyndhurst

    Lyndhurst, Ohio, 44124

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Georgia Institute for Clinical Research

    Marietta, Georgia, 30060

  • Rama Research LLC

    Marion, Ohio, 43302

  • RAS Health Ltd

    Marion, Ohio, 43302

  • DCT - McAllen Primary Care, LLC

    McAllen, Texas, 78503

  • Lemah Creek Clinical Research

    Melrose Park, Illinois, 60160

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Clinical Trials Management LLC - Southshore

    Metairie, Louisiana, 70006

  • AMPM Research Clinic

    Miami Gardens, Florida, 33169

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina, 28557

  • Exemplar Research Inc. - Fairmont, WV

    Morgantown, West Virginia, 26505

  • Koch Family Medicine

    Morton, Illinois, 61550

  • Summit Research Group, LLC

    Munroe Falls, Ohio, 44262

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34653

  • Mid-Hudson Medical Research, PLLC - Hopewell Junction

    New Windsor, New York, 12553

  • Mid-Hudson Medical Research, PLLC - New Windsor

    New Windsor, New York, 12553

  • York Clinical Research LLC

    Norfolk, Virginia, 23510

  • Lucita M. Cruz, MD., Inc.

    Norwalk, California, 90650

  • Ocala Cardiovascular Research

    Ocala, Florida, 34474

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

  • Research Integrity LLC

    Owensboro, Kentucky, 42303

  • South Florida Research Solutions LLC. - Pembroke Pines

    Pembroke Pines, Florida, 33029

  • Phoenix Medical Research Institute, LLC

    Peoria, Arizona, 85381

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • David M. Headley, MD P.A.

    Port Gibson, Mississippi, 39150

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Center for Medical Research, LLC

    Providence, Rhode Island, 02908

  • Health Concepts

    Rapid City, South Dakota, 57702

  • San Antonio Premier Internal Medicine

    San Antonio, Texas, 78220

  • Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute

    San Antonio, Texas, 78228

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • Bandera Family HealthCare Research, LLC (BFHC)

    San Antonio, Texas, 78249

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Meridian Clinical Research - Savannah, GA

    Savannah, Georgia, 31406

  • Clinical Research Solutions - Smyrna, TN

    Smyrna, Tennessee, 37167

  • Consult and Research Associates

    St Louis, Missouri, 63122

  • Advance Clinical Research, Inc

    St Louis, Missouri, 63128

  • Clinical Research Institute of Arizona, LLC

    Surprise, Arizona, 85374

  • Meridien Research - Tampa

    Tampa, Florida, 33634

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Terence T. Hart, MD

    Tuscumbia, Alabama, 35674

  • Buynak Clinical Research, P.C.

    Valparaiso, Indiana, 46383

  • Allegiance Research Specialists, LLC

    Wauwatosa, Wisconsin, 53226

  • The Iowa Clinic - Cardiovascular Services

    West Des Moines, Iowa, 50266

  • Clinical Trials of America, LLC - West Monroe, LA

    West Monroe, Louisiana, 71291

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67205-1138

  • Ohio Clinical Research, LLC - Willoughby Hills

    Willoughby Hills, Ohio, 44094

Other trials in United States

Russia41 sites

  • First City Clinical Hospital n.a. E.E.Volosevich

    Arkhangelsk

  • Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency

    Arkhangelsk

  • Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction

    Barnaul

  • Chita State Medical Academy

    Chita

  • Interregional Clinical Diagnostic Center

    Kazan'

  • Kazan State Medical University based at City Clinical Hospital #7

    Kazan'

  • Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases"

    Kemerovo

  • Medical Center "Alliance"

    Kirovsk

  • Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky

    Krasnoyarsk

  • Central Clinical Hospital of Russian Academy of Sciences

    Moscow

  • City Clinical Hospital #15 n.a. O.M. Filatov

    Moscow

  • City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department

    Moscow

  • Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department

    Moscow

  • National Medical Research Center of Cardiology - Department of Atherosclerosis

    Moscow

  • National Medical Research Center of Cardiology

    Moscow

  • National Medical Research Center of Preventive Medicine

    Moscow

  • Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")

    Moscow

  • City Clinical Hospital No.2

    Novosibirsk

  • RC Medical LLC

    Novosibirsk

  • Research Institute of Physiology and Fundamental Medicine

    Novosibirsk

  • Orenburg State Medical University based at City Clinical Hospital #1

    Orenburg

  • Clinical-diagnostic center "Zdorovye"

    Rostov-on-Don

  • Rostov-on-Don City Hospital of Emergency Care

    Rostov-on-Don

  • Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology

    Saint Petersburg

  • Almazov National Medical Research Centre

    Saint Petersburg

  • BioTechService LLC

    Saint Petersburg

  • City hospital #38 n.a. N.A. Semashko

    Saint Petersburg

  • Clinic Complex JSC

    Saint Petersburg

  • Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency

    Saint Petersburg

  • Consultative Diagnostic Center with Out-patient Clinic

    Saint Petersburg

  • Limited Liability Company "MedPomosch"

    Saint Petersburg

  • Medical Technologies LLC

    Saint Petersburg

  • North-Western State Medical University named after I.I. Mechnikov

    Saint Petersburg

  • Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen

    Saint Petersburg

  • Regional Clinical Cardiology Dispensary

    Saratov

  • Saratov State Medical University n. a. V.I. Razumovsky

    Saratov

  • Tomsk National Research Medical Center of Russian Academy of Sciences

    Tomsk

  • Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre

    Voronezh

  • Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"

    Yaroslavl

  • Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District

    Yekaterinburg

  • City Clinical Hospital n.a. M.P. Konchalovskiy

    Zelenograd, Moscow

Other trials in Russia

Ukraine13 sites

  • Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department

    Ivano-Frankivsk

  • JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1

    Kharkiv

  • JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2

    Kharkiv

  • Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council

    Kharkiv

  • Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council

    Kharkiv

  • Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council

    Kharkiv

  • Kyiv City Clinical Hospital #1, Urgent Cardiology Department

    Kyiv

  • Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department

    Kyiv

  • 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

  • SI "Institute of Gerontology n.a. D.F.Chebotarev NAMS of Ukraine", Cardiol. Un. of Clin. Physiology and Int. Organs Path. Dep-t

    Kyiv

  • Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department

    Odesa

  • Small Private Enterprise, Medical Centre "Puls"

    Vinnytsia

  • Municipal Institution "City Clinical Hospital #6", Therapeutic Department

    Zaporizhzhya

Other trials in Ukraine

Poland12 sites

  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman

    Gdynia

  • SALVIA Lekston i Madej s.j.

    Katowice

  • Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O

    Krakow

  • AppleTreeClinics Sp. z o.o.

    Lodz

  • NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek

    Lodz

  • Nzoz Salusmed

    Lodz

  • MEDICOME Sp. z o.o.

    Oświęcim

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O

    Płock

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan

  • Clinmedica Research Omc Sp z o.o. Sp

    Skierniewice

  • Centrum Kardiologiczne Pro Corde Sp. z o. o.

    Wroclaw

Other trials in Poland

Belarus10 sites

  • Brest Regional Hospital

    Brest

  • Grodno University Hospital

    Grodno

  • Gomel Regional Clinical Center of Cardiology

    Homyel

  • Gomel Regional Clinical Hospital

    Homyel

  • City Clinical Hospital #10

    Minsk

  • City Clinical Hospital #1

    Minsk

  • Minsk Regional Clinical Hospital

    Minsk

  • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology

    Minsk

  • Mogilev Regional Medical and Diagnostic Center

    Mogilev

  • Vitebsk Regional Clinical Hospital

    Vitebsk

Other trials in Belarus

Bulgaria9 sites

  • Medical Center Diamedical 2013 OOD

    Dimitrovgrad

  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic

    Pleven

  • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic

    Pleven

  • UMHAT Sveti Georgi - Clinic of Cardiology

    Plovdiv

  • MHAT Dr. Bratan Shukjerov

    Smolyan

  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

    Smolyan

  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology

    Sofia

  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases

    Sofia

  • Medical Center Orfey OOD

    Stara Zagora

Other trials in Bulgaria

Hungary9 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred

  • DRC Balatongyorok

    Balatongyörök

  • Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

    Békéscsaba

  • Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly

    Budapest

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen

  • BKS Research Kft.

    Hatvan

  • Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika

    Pécs

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár

Other trials in Hungary

Czechia8 sites

  • Lipidova poradna

    Bílina

  • Medicus Services SRO

    Brandýs nad Labem

  • Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka

    Hradec Králové

  • Onkologicka klinika 2. LF UK a FN Motol

    Prague

  • Ordinace pro choroby srdce a cev

    Prague

  • Vseobecna fakultni nemocnice v Praze

    Prague

  • Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie

    Trutnov

  • MUDr. Nina Zemkova s.r.o. Interni Ambulance

    Uherské Hradište

Other trials in Czechia

Georgia8 sites

  • Unimed Ajara LLC

    Batumi

  • Clinic LJ Ltd

    Kutaisi

  • Aleksandre Aladashvili Clinic - LLC

    Tbilisi

  • Archangel St Michael Multiprofile Clinical Hospital Ltd

    Tbilisi

  • Emergency Cardiology Center by Academician G. Chapidze Ltd

    Tbilisi

  • Institute of Clinical Cardiology Ltd

    Tbilisi

  • Unimed Kakheti - Caraps Medline LLC

    Tbilisi

  • Unimed Kakheti - Telavi Referral Hospital LLC

    Telavi

Other trials in Georgia

About this study

Official title: A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind 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 Normal Renal Function

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.

Being tested
K-877, Fenofibrate, Placebo (for K-877), Placebo (for Fenofibrate)
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • K-877Drug

  • FenofibrateDrug

  • Placebo (for K-877)Drug

  • Placebo (for Fenofibrate)Drug

Study groups in NCT03001817
Study groupRoleWhat they receive
12 Week EfficacyPlacebo comparatorK-877 or placebo comparator twice daily for 12 weeks
Receives: Drug: K-877; Drug: Placebo (for K-877)
40 Week ExtensionActive comparatorK-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks
Receives: Drug: K-877; Drug: Fenofibrate; Drug: Placebo (for K-877); Drug: Placebo (for Fenofibrate)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 Weeks

Secondary outcomes (113)

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

  16. Change From Baseline to Week 12 in hsCRP

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 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.

    Measured: 12 Weeks

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

    Measured: 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.

    Measured: 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.

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 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.

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 12 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

  62. Percent Change From Baseline to Week 52 in TC

    Measured: 52 Weeks

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

    Measured: 52 Weeks

  64. Percent Change From Baseline to Week 52 in FFAs

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

  72. Change From Baseline to Week 52 in FGF21

    Measured: 52 Weeks

  73. Change From Baseline to Week 52 in hsCRP

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 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.

    Measured: 52 Weeks

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

    Measured: 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.

    Measured: 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.

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 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.

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

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

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study start28 Nov 2016
  3. Primary completion24 Jun 2019
  4. Study completion24 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001817
Sponsor's protocol ID
K-877-301
Status last verified
Nov 2022
First submitted
29 Nov 2016
Last updated
30 Nov 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing K-877 and Fenofibrate in people with Severe Hypertriglyceridemia, run by Kowa Research Institute, Inc. at 220 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, Russia, Ukraine, Poland, Belarus and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03001817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.

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