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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03001817

Public ClinicalTrials.gov record NCT03001817. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 12:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT03001817
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kowa Research Institute, Inc.
Industry
Enrollment
551 participants

Conditions and interventions

Interventions

  • Fenofibrate Drug
  • K-877 Drug
  • Placebo (for Fenofibrate) Drug
  • Placebo (for K-877) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 27, 2016
Primary completion
Jun 23, 2019
Completion
Jun 23, 2019
Last update posted
Nov 29, 2022

2016 – 2019

United States locations

U.S. sites
110
U.S. states
35
U.S. cities
97
Facility City State ZIP Site status
Central Research Associates, Inc. Birmingham Alabama 35205
Central Alabama Research Birmingham Alabama 35209
Cahaba Research, Inc. Birmingham Alabama 35242
Boyett Health Services Inc Hamilton Alabama 35570
Longwood Research - Saadat Ansari, MD, LLC Huntsville Alabama 35801
Terence T. Hart, MD Tuscumbia Alabama 35674
Arrowhead Health Centers Glendale Arizona 85306
Phoenix Medical Research Institute, LLC Peoria Arizona 85381
Elite Clinical Studies Phoenix Arizona 85018
Clinical Research Institute of Arizona, LLC Surprise Arizona 85374
iResearch - Little Rock Little Rock Arkansas 72205
Lynn Institute of the Ozarks Little Rock Arkansas 72205
Advanced Research Center Anaheim California 92805
Torrance Clinical Research Institute Inc. Lomita California 90717
Downtown L.A. Research Center, Inc. Los Angeles California 90017
Catalina Research Institute, LLC Montclair California 91763
Lucita M. Cruz, MD., Inc. Norwalk California 90650
Creekside Endocrine Associates, PC Denver Colorado 80246
Atlantic Clinical Research Collaborative Boynton Beach Florida 33472
ALL Medical Research, LLC Cooper City Florida 33024
S & W Clinical Research Fort Lauderdale Florida 33306
Indago Research and Health Center Hialeah Florida 33012
Jacksonville Impotence Treatment Center Jacksonville Florida 32223
AMPM Research Clinic Miami Gardens Florida 33169
Advanced Research Institute Inc New Port Richey Florida 34653
Ocala Cardiovascular Research Ocala Florida 34474
South Florida Research Solutions LLC. - Pembroke Pines Pembroke Pines Florida 33029
Progressive Medical Research Port Orange Florida 32127
Cardiovascular Center of Sarasota Sarasota Florida 34239
Meridien Research - Tampa Tampa Florida 33634
Columbus Regional Health Columbus Georgia 31904
Physicians Research Associates, Inc Lawrenceville Georgia 30046
Georgia Institute for Clinical Research Marietta Georgia 30060
Meridian Clinical Research - Savannah, GA Savannah Georgia 31406
Solaris Clinical Research Meridian Idaho 83646
Apex Medical Research - Illinois Chicago Illinois 60616
Lemah Creek Clinical Research Melrose Park Illinois 60160
Koch Family Medicine Morton Illinois 61550
Community Hospital of Anderson and Madison County, Inc Anderson Indiana 46011
American Health Network - Avon Clinical Research Department Avon Indiana 46103
Medisphere Medical Research Center Evansville Indiana 47714
Midwest Institute for Clinical Research Indianapolis Indiana 46260
Buynak Clinical Research, P.C. Valparaiso Indiana 46383
West Broadway Clinic Council Bluffs Iowa 51501
The Iowa Clinic - Cardiovascular Services West Des Moines Iowa 50266
Professional Research Network of Kansas, LLC Wichita Kansas 67205-1138
The Research Group of Lexington, LLC Lexington Kentucky 40503
Research Integrity LLC Owensboro Kentucky 42303
Clinical Trials Management, LLC - Northshore Covington Louisiana 70443
Clinical Trials Management LLC - Southshore Metairie Louisiana 70006
Clinical Trials of America, LLC - West Monroe, LA West Monroe Louisiana 71291
Maryland Cardiovascular Specialist Baltimore Maryland 21229
Aa Mrc, Llc Flint Michigan 48504
Oakland Medical Research Center Troy Michigan 48085
David M. Headley, MD P.A. Port Gibson Mississippi 39150
Consult and Research Associates St Louis Missouri 63122
Advance Clinical Research, Inc St Louis Missouri 63128
Glacier View Research Institute Kalispell Montana 59901
Desert Endocrinology Clinical Research Center - Henderson Henderson Nevada 89052
Palm Research Center, Inc. Las Vegas Nevada 89148
Lovelace Scientific Resources Albuquerque New Mexico 87108
Lakeshore Primary Care Associate Hamburg New York 14075
Mid-Hudson Medical Research, PLLC - Hopewell Junction New Windsor New York 12553
Mid-Hudson Medical Research, PLLC - New Windsor New Windsor New York 12553
Orchard Park Family Practice Orchard Park New York 14127
Diabetes and Endocrinology Consultants, P.C. Morehead City North Carolina 28557
Lillestol Research, LLC Fargo North Dakota 58104
Sterling Research Group, Ltd. - Auburn Cincinnati Ohio 45219
Aventiv Research, Inc. Columbus Ohio 43213
Alpha Research Associates, LLC Dayton Ohio 45417
Prestige Clinical Research Franklin Ohio 45005
Ohio Clinical Research - Lyndhurst Lyndhurst Ohio 44124
Rama Research LLC Marion Ohio 43302
RAS Health Ltd Marion Ohio 43302
Summit Research Group, LLC Munroe Falls Ohio 44262
Ohio Clinical Research, LLC - Willoughby Hills Willoughby Hills Ohio 44094
South Oklahoma Heart Research Oklahoma City Oklahoma 73135
Clinical Research Associates of Central PA, LLC Altoona Pennsylvania 16602
Harleysville Medical Associates Harleysville Pennsylvania 19438
Richard M.Kastelic MD and Associates Johnstown Pennsylvania 15905
Green and Seidner Family Practice Associates Lansdale Pennsylvania 19446
Center for Medical Research, LLC Providence Rhode Island 02908
DeGarmo Institute Of Medical Research Greer South Carolina 29650
Health Concepts Rapid City South Dakota 57702
PMG Research of Bristol, LLC - State Bristol Tennessee 37620
New Phase Research & Development - Knoxville Knoxville Tennessee 37909
Clinical Research Solutions - Smyrna, TN Smyrna Tennessee 37167
Health Innovation Research Group Arlington Texas 76014
DCT-AACT, LLC, dba Discovery Clinical Trials Austin Texas 78758
Inquest Clinical Research Baytown Texas 77521
Protenium Clinical Research, LLC - Dallas Dallas Texas 75208
VA North Texas Health Care System - Dallas VA Medical Center (DVAMC) Dallas Texas 75216
Academy of Diabetes, Thyroid and Endocrine, P.A. El Paso Texas 79935
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
Grace Research, LLC - Huntsville, TX Huntsville Texas 77340
Protenium Clinical Research, LLC Hurst Texas 76054
Juno Research, LLC - Katy Katy Texas 77450
FMC Science Lampasas Texas 76550
DCT - McAllen Primary Care, LLC McAllen Texas 78503
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
Manassas Clinical Research Center Manassas Virginia 20110
York Clinical Research LLC Norfolk Virginia 23510
Exemplar Research Inc. - Fairmont, WV Morgantown West Virginia 26505
Allegiance Research Specialists, LLC Wauwatosa Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 110 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03001817, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 29, 2022 · Synced May 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03001817 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →