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

November 9, 2022 updated by: Kowa Research Institute, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
551

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Brest, Belarus
        • Brest Regional Hospital
      • Gomel, Belarus
        • Gomel Regional Clinical Center of Cardiology
      • Gomel, Belarus
        • Gomel Regional Clinical Hospital
      • Grodno, Belarus
        • Grodno University Hospital
      • Minsk, Belarus
        • City Clinical Hospital #10
      • Minsk, Belarus
        • City Clinical Hospital #1
      • Minsk, Belarus
        • Minsk Regional Clinical Hospital
      • Minsk, Belarus
        • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
      • Mogilev, Belarus
        • Mogilev Regional Medical and Diagnostic Center
      • Vitebsk, Belarus
        • Vitebsk Regional Clinical Hospital
  • Bulgaria
      • Dimitrovgrad, Bulgaria
        • Medical Center Diamedical 2013 OOD
      • Pleven, Bulgaria
        • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- First Cardiology Clinic
      • Pleven, Bulgaria
        • University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski EAD- Second Cardiology Clinic
      • Plovdiv, Bulgaria
        • UMHAT Sveti Georgi - Clinic of Cardiology
      • Smolyan, Bulgaria
        • MHAT Dr. Bratan Shukjerov
      • Smolyan, Bulgaria
        • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
      • Sofia, Bulgaria
        • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Cardiology
      • Sofia, Bulgaria
        • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD - Department of Endocrinology and Meteorism Diseases
      • Stara Zagora, Bulgaria
        • Medical Center Orfey OOD
  • Czechia
      • Bilina, Czechia
        • Lipidova poradna
      • Brandýs nad Labem, Czechia
        • Medicus Services sro
      • Hradec Kralove, Czechia
        • Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka
      • Praha 10, Czechia
        • Ordinace pro choroby srdce a cev
      • Praha 2, Czechia
        • Vseobecna Fakultni Nemocnice V Praze
      • Praha 5, Czechia
        • Onkologicka klinika 2. LF UK a FN Motol
      • Trutnov, Czechia
        • Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie
      • Uherské Hradište, Czechia
        • MUDr. Nina Zemkova s.r.o. Interni Ambulance
  • Georgia
      • Batumi, Georgia
        • Unimed Ajara LLC
      • Kutaisi, Georgia
        • Clinic LJ Ltd
      • Tbilisi, Georgia
        • Aleksandre Aladashvili Clinic - LLC
      • Tbilisi, Georgia
        • Archangel St Michael Multiprofile Clinical Hospital Ltd
      • Tbilisi, Georgia
        • Emergency Cardiology Center by Academician G. Chapidze Ltd
      • Tbilisi, Georgia
        • Institute of Clinical Cardiology Ltd
      • Tbilisi, Georgia
        • Unimed Kakheti - Caraps Medline LLC
      • Telavi, Georgia
        • Unimed Kakheti - Telavi Referral Hospital LLC
  • Hungary
      • Balatonfüred, Hungary
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Balatongyorok, Hungary
        • DRC Balatongyorok
      • Bekescsaba, Hungary
        • Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
      • Budapest, Hungary
        • Magyar Honvédség Egészségügyi Központ
      • Budapest, Hungary
        • Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont
      • Hatvan, Hungary
        • BKS Research Kft.
      • Pecs, Hungary
        • Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika
      • Szekesfehervar, Hungary
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Poland
      • Gdynia, Poland
        • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
      • Katowice, Poland
        • SALVIA Lekston i Madej s.j.
      • Krakow, Poland
        • Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O
      • Lodz, Poland
        • AppleTreeClinics Sp. z o.o.
      • Lodz, Poland
        • NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek
      • Lodz, Poland
        • Nzoz Salusmed
      • Oswiecim, Poland
        • Medicome Sp. z o.o.
      • Plock, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O
      • Poznan, Poland
        • Centrum Zdrowia Metabolicznego Pawel Bogdanski
      • Poznan, Poland
        • Praktyka Lekarska Ewa Krzyzagorska
      • Skierniewice, Poland
        • Clinmedica Research Omc Sp z o.o. Sp
      • Wroclaw, Poland
        • Centrum Kardiologiczne Pro Corde Sp. z o. o.
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • First City Clinical Hospital n.a. E.E.Volosevich
      • Arkhangelsk, Russian Federation
        • Northern Medical Clinical Center named after N.A. Semashko of the Federal Medical and Biological Agency
      • Barnaul, Russian Federation
        • Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction
      • Chita, Russian Federation
        • Chita State Medical Academy
      • Ekaterinburg, Russian Federation
        • Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District
      • Kazan, Russian Federation
        • Interregional Clinical Diagnostic Center
      • Kazan, Russian Federation
        • Kazan State Medical University based at City Clinical Hospital #7
      • Kemerovo, Russian Federation
        • Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases"
      • Kirovsk, Russian Federation
        • Medical Center "Alliance"
      • Krasnoyarsk, Russian Federation
        • Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky
      • Moscow, Russian Federation
        • Central Clinical Hospital of Russian Academy of Sciences
      • Moscow, Russian Federation
        • City Clinical Hospital #15 n.a. O.M. Filatov
      • Moscow, Russian Federation
        • City Clinical Hospital n.a. M.E. Zhadkevich of Moscow Healthcare Department
      • Moscow, Russian Federation
        • Federal State Budget Institution "Outpatient Clinic #3" of Russian Federation President's Management Department
      • Moscow, Russian Federation
        • National Medical Research Center of Cardiology - Department of Atherosclerosis
      • Moscow, Russian Federation
        • National Medical Research Center of Cardiology
      • Moscow, Russian Federation
        • National Medical Research Center of Preventive Medicine
      • Moscow, Russian Federation
        • Non-governmental Private Healthcare Institution "Scientific Clinical Centre of Open Joint-Stock Company Russian Railways" (JSC "RZD")
      • Novosibirsk, Russian Federation
        • City Clinical Hospital No.2
      • Novosibirsk, Russian Federation
        • RC Medical LLC
      • Novosibirsk, Russian Federation
        • Research Institute of Physiology and Fundamental Medicine
      • Orenburg, Russian Federation
        • Orenburg State Medical University based at City Clinical Hospital #1
      • Rostov-on-Don, Russian Federation
        • Clinical-diagnostic center "Zdorovye"
      • Rostov-on-Don, Russian Federation
        • Rostov-on-Don City Hospital of Emergency Care
      • Saint Petersburg, Russian Federation
        • Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology
      • Saint Petersburg, Russian Federation
        • BioTechService LLC
      • Saint Petersburg, Russian Federation
        • Clinic Complex JSC
      • Saint Petersburg, Russian Federation
        • Limited Liability Company "MedPomosch"
      • Saint Petersburg, Russian Federation
        • Medical Technologies LLC
      • Saint Petersburg, Russian Federation
        • North-Western State Medical University named after I.I. Mechnikov
      • Saint-Petersburg, Russian Federation
        • City hospital #38 n.a. N.A. Semashko
      • Saratov, Russian Federation
        • Regional clinical cardiology dispensary
      • Saratov, Russian Federation
        • Saratov State Medical University n. a. V.I. Razumovsky
      • St-Petersburg, Russian Federation
        • Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Cardiology Departmen
      • St. Petersburg, Russian Federation
        • Almazov National Medical Research Centre
      • St. Petersburg, Russian Federation
        • Clinical Hospital #122 n. a. L.G. Sokolov of the Federal Medical Biological Agency
      • St. Petersburg, Russian Federation
        • Consultative Diagnostic Center with Out-patient Clinic
      • Tomsk, Russian Federation
        • Tomsk National Research Medical Center of Russian Academy of Sciences
      • Voronezh, Russian Federation
        • Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre
      • Yaroslavl, Russian Federation
        • Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie"
    • Moscow
      • Zelenograd, Moscow, Russian Federation
        • City Clinical Hospital n.a. M.P. Konchalovskiy
  • Ukraine
      • Ivano-Frankivsk, Ukraine
        • Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department
      • Kharkiv, Ukraine
        • JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #1
      • Kharkiv, Ukraine
        • JSC "Ukrainian Railways" Kharkiv Railway Clinical Hospital#1 of Branch "Healthcare Center" of PJSC "Ukrainian Railways", Cardiology Depart #2
      • Kharkiv, Ukraine
        • Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov" of Kharkiv City Council
      • Kharkiv, Ukraine
        • Municipal Noncommercial Enterprise "City Clinical Hospital #27" of Kharkiv City Council
      • Kharkiv, Ukraine
        • Municipal Noncommercial Enterprise "City Outpatient Clinic #9" of Kharkiv City Council
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #1, Urgent Cardiology Department
      • Kyiv, Ukraine
        • Limited Liability Company "Treatment and Diagnostic Center "Adonis Plus"", Outpatient Department
      • Kyiv, Ukraine
        • 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
        • 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
        • Municipal Institution "City Clinical Hospital #3 n.a. prof. L.J. Aleinikova", Cardiology Intensive Therapy Department
      • Vinnytsya, Ukraine
        • Small Private Enterprise, Medical Centre "Puls"
      • Zaporizhzhia, Ukraine
        • 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 - Little Rock
    • 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
      • Norwalk, California, United States, 90650
        • Lucita M. Cruz, MD., Inc.
    • 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. - Pembroke Pines
      • 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
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Health
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Associates, Inc
      • Marietta, Georgia, United States, 30060
        • Georgia Institute for Clinical Research
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research - Savannah, GA
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Apex Medical Research - Illinois
      • Melrose Park, Illinois, United States, 60160
        • Lemah Creek Clinical Research
      • 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, 67205-1138
        • Professional Research Network of Kansas, LLC
    • Kentucky
      • 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
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America, LLC - West Monroe, LA
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Maryland Cardiovascular Specialist
    • 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 - Henderson
      • 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, 58104
        • 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, 44262
        • 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
    • 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, 02908
        • Center for Medical Research, LLC
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • DeGarmo Institute of Medical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol, LLC - State
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research & Development - Knoxville
      • 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
      • 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, 77058
        • Centex Studies, Inc.
      • Houston, Texas, United States, 77040
        • Juno Research, LLC - Northwest Site
      • Houston, Texas, United States, 77074
        • Juno Research, LLC - Southwest Houston Site
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions Inc.
      • Huntsville, Texas, United States, 77340
        • Grace Research, LLC - Huntsville, TX
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research, LLC
      • Katy, Texas, United States, 77450
        • Juno Research, LLC - Katy
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • 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, 78229
        • Pinnacle Clinical Research
      • 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, 23510
        • York Clinical Research LLC
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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, criterion 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;

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 12 Week Efficacy
K-877 or placebo comparator twice daily for 12 weeks
Drug: K-877
Drug: Placebo (for K-877)
Active Comparator: 40 Week Extension
K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks
Drug: Fenofibrate
Drug: K-877
Drug: Placebo (for K-877)
Drug: Placebo (for Fenofibrate)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Week 12 in Remnant Cholesterol
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in HDL-C
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo A1
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Non-HDL-C
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Total Cholesterol
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in LDL-C
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Free Fatty Acids (FFAs)
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo A2
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo B
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo B48
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo B100
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo C2
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo C3
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Apo E
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Fibroblast Growth Factor 21 (FGF21)
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in hsCRP
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Small
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 1
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Intermediate Density Lipoproteins 2
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins I
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIa
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIb
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIa
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IIIb
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVa
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVb
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - Low Density Lipoproteins IVc
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 2b
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Ion Mobility - High Density Lipoproteins 3 and 2a
Time Frame: 12 Weeks
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 - Major LDL Particle Measurement
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Time Frame: 12 Weeks
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 - VLDL & Chylomicron Particles-Large
Time Frame: 12 Weeks
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
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particles-Small
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total)
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (IDL) Particles
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Large
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles-Small
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles (Total)
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Large
Time Frame: 12 Weeks
12 Weeks
Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Medium
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particles-Small
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL Particle Size
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particle Size
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - HDL Particle Size
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - Triglyceride (Total)
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Time Frame: 12 Weeks
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
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Total Cholesterol (TC):HDL-C
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time Frame: 12 Weeks
12 Weeks
Percent Change From Baseline to Week 52 in Fasting TG
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Remnant Cholesterol
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in HDL-C
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo A1
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Non-HDL-C
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in TC
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in LDL-C
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in FFAs
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo A2
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo B
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo B48
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo B100
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo C2
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo C3
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Apo E
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in FGF21
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in hsCRP
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Large
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Intermediate
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - VLDL Cholesterol-Small
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 1
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Intermediate Density Lipoproteins 2
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins I
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIa
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIb
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIa
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IIIb
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVa
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVb
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - Low Density Lipoproteins IVc
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 2b
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Ion Mobility - High Density Lipoproteins 3 and 2a
Time Frame: 52 Weeks
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
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Particles
Time Frame: 52 Weeks
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 - VLDL & Chylomicron Particles-Large
Time Frame: 52 Weeks
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
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particles-Small
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total)
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - IDL Particles
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Large
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles-Small
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Large
Time Frame: 52 Weeks
52 Weeks
Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Medium
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particles-Small
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL Particle Size
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particle Size
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - HDL Particle Size
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - Triglyceride
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipoprotein Fraction - VLDL & Chylomicron Triglyceride
Time Frame: 52 Weeks
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
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1
Time Frame: 52 Weeks
52 Weeks
Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2
Time Frame: 52 Weeks
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K-877-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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