ClinicalTrials.gov record
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 May 18, 2026, 1:13 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, 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
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
Conditions
Interventions
- Fenofibrate Drug
- K-877 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 25, 2016
- Primary completion
- Jul 4, 2019
- Completion
- Jul 4, 2019
- Last update posted
- Oct 27, 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 27, 2022 · Synced May 18, 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 NCT03011450 live on ClinicalTrials.gov.