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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 Mild or Moderate Renal Impairment

ClinicalTrials.gov ID: NCT03011450

Public ClinicalTrials.gov record NCT03011450. 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 Oct 22, 2026, 4:58 PM 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, 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03011450
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kowa Research Institute, Inc.
Industry
Enrollment
471 participants

Conditions and interventions

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 26, 2016 (Actual)
Primary completion
Jul 5, 2019 (Actual)
Completion
Jul 5, 2019 (Actual)
Last update posted
Oct 28, 2022

2016 – 2019

United States locations

U.S. sites
129
U.S. states
36
U.S. cities
112
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 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 —
Pacific Coast Cardiology and Research Newport Beach California 92663 —
Lucita M. Cruz, MD., Inc. Norwalk California 90650 —
Integrated Research Center San Diego California 92117 —
Optimus Medical Group San Francisco California 94102 —
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 Florida 33029 —
Progressive Medical Research Port Orange Florida 32127 —
Cardiovascular Center of Sarasota Sarasota Florida 34239 —
Meridien Research - Tampa Tampa Florida 33634 —
Meridien Research Tampa Florida 33634 —
Columbus Regional Health Columbus Georgia 31904 —
iResearch Decatur Georgia 30030 —
Physicians Research Associates, Inc Lawrenceville Georgia 30046 —
Georgia Institute for Clinical Research Marietta Georgia 30060 —
Endocrine Research Solutions, Inc Roswell Georgia 30076 —
Meridian Clinical Research - Savannah, GA Savannah Georgia 31406 —
Solaris Clinical Research Meridian Idaho 83646 —
Lemah Creek Clinical Research Burr Ridge Illinois 60527 —
Cedar-Crosse Research Center Chicago Illinois 60607 —
Apex Medical Research Chicago Illinois 60616 —
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 —
Kentucky Diabetes Endocrinology Center Lexington Kentucky 40503 —
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 —
Grace Research, LLC Shreveport Louisiana 71105 —
Clinical Trials of America, LLC West Monroe Louisiana 71291 —
Maryland Cardiovascular Specialists Baltimore Maryland 21229 —
Regeneris Medical North Attleboro Massachusetts 2760 —
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 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 58103 —
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 44626 —
Ohio Clinical Research, LLC - Willoughby Hills Willoughby Hills Ohio 44094 —
COR Clinical Research, LLC. Oklahoma City Oklahoma 73107 —
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 2908 —
MD First Research Anderson South Carolina 29625 —
MDFirst Research - Anderson Anderson South Carolina 29625 —
DeGarmo Institute Of Medical Research Greer South Carolina 29650 —
MD First Research Lancaster South Carolina 29720 —
Family Medicine of SayeBrook Myrtle Beach South Carolina 29588 —
Health Concepts Rapid City South Dakota 57702 —
PMG Research of Bristol, LLC - State Bristol Tennessee 37620 —
Chattanooga Research & Medicine, PLLC Chattanooga Tennessee 37404 —
Holston Medical Group Kingsport Tennessee 37660 —
New Phase Research & Development 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 —
Padre Coast Clinical Research Corpus Christi Texas 78404 —
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 Houston Texas 77040 —
Centex Studies, Inc. Houston Texas 77058 —
Juno Research, LLC Houston Texas 77074 —
Pioneer Research Solutions Inc. Houston Texas 77099 —
Grace Research, LLC Huntsville Texas 77340 —
Protenium Clinical Research, LLC Hurst Texas 76054 —
Juno Research, LLC Katy Texas 77450 —
FMC Science Lampasas Texas 76550 —
Pinnacle Clinical Research Live Oak Texas 78233 —
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 —
Bandera Family HealthCare Research, LLC (BFHC) San Antonio Texas 78249 —
Manassas Clinical Research Center Manassas Virginia 20110 —
York Clinical Research LLC Norfolk Virginia 23501 —
Cardiovascular Associates, Ltd Virginia Beach Virginia 23454 —
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 112 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03011450, 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 Oct 28, 2022 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03011450 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →