Severe Hypertriglyceridemia Clinical Trial
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
| Verified date | September 2022 |
| Source | Kowa Research Institute, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 471 |
| Est. completion date | July 5, 2019 |
| Est. primary completion date | July 5, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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, 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; 5. Fasting TG levels =500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1). - Mild to moderate renal impairment eGFR >= 30mL/min/1.73 and < 90 mL/min/1.73 at Visit 1 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); |
| Country | Name | City | State |
|---|---|---|---|
| Belarus | Brest Regional Hospital | Brest | |
| Belarus | Gomel Regional Clinical Center of Cardiology | Gomel | |
| Belarus | Gomel Regional Clinical Hospital | Gomel | |
| Belarus | Grodno University Hospital | Grodno | |
| Belarus | City Clinical Hospital #1 | Minsk | |
| Belarus | City Clinical Hospital #10 | Minsk | |
| Belarus | City Clinical Hospital #9 | Minsk | |
| Belarus | Minsk Regional Clinical Hospital | Minsk | |
| Belarus | Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology | Minsk | |
| Belarus | Mogilev Regional Medical and Diagnostic Center | Mogilev | |
| Belarus | Vitebsk Regional Clinical Hospital | Vitebsk | |
| Bulgaria | Medical Center Diamedical 2013 OOD | Dimitrovgrad | |
| 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 | Pleven | |
| Bulgaria | University Multiprofile Hospital for Active Treatment (UMHAT) Sveti Georgi, EAD - Clinic of Cardiology | Plovdiv | |
| Bulgaria | MHAT Dr. Bratan Shukjerov | Smolyan | |
| Bulgaria | Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD | Smolyan | |
| 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 | Sofia | |
| Bulgaria | Medical Center Orfey OOD | Stara Zagora | |
| Czechia | Lipidova poradna | Bílina | |
| Czechia | Medicus Services SRO | Brandýs nad Labem | |
| Czechia | Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka | Hradec Králové | |
| Czechia | Ordinace pro choroby srdce a cev | Praha 10 | |
| Czechia | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
| Czechia | Fakultni nemocnice v Motole | Praha 5 | |
| Czechia | Oblastni nemocnice Trutnov, Oddeleni klinicke biochemie | Trutnov | |
| Czechia | MUDr. Nina Zemkova s.r.o. Interni Ambulance | Uherské Hradište | |
| Georgia | Unimed Ajara LLC | Batumi | |
| Georgia | Clinic LJ Ltd | Kutaisi | |
| 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 | Tbilisi | |
| Georgia | Unimed Kakheti - Telavi Referral Hospital LLC | Telavi | |
| Hungary | DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | |
| Hungary | DRC Balatongyorok | Balatongyörök | |
| Hungary | Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo | Békéscsaba | |
| Hungary | Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly | Budapest | |
| Hungary | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont | Debrecen | |
| Hungary | BKS Research Kft. | Hatvan | |
| Hungary | Pecsi Tudomanyegyetem Klinikai Kozpont I.sz. Belgyogyaszati Klinika | Pécs | |
| Hungary | Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | |
| Poland | Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman | Gdynia | |
| Poland | SALVIA Lekston i Madej s.j. | Katowice | |
| Poland | Malopolskie Centrum Alergii i Immunoterapii Allmedis SP Z O O | Krakow | |
| Poland | AppleTreeClinics Sp. z o.o. | Lódz | |
| Poland | NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek | Lódz | |
| Poland | Nzoz Salusmed | Lódz | |
| Poland | MEDICOME Sp. z o.o. | Oswiecim | |
| Poland | Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne OMEGA SP Z O O | Plock | |
| Poland | Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | |
| Poland | Praktyka Lekarska Ewa Krzyzagorska | Poznan | |
| Poland | Clinmedica Research Omc Sp z o.o. Sp | Skierniewice | |
| Poland | Centrum Kardiologiczne Pro Corde Sp. z o. o. | Wroclaw | |
| 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 | Arkhangelsk | |
| Russian Federation | Altay Regional Cardiology Dispensary, Cardiology Department for Patients with Acute Myocardial Infarction | Barnaul | |
| Russian Federation | Chita State Medical Academy | Chita | |
| Russian Federation | Ural State Medical University based at Central City Clinical Hospital No.1 of Oktyabrskiy District | Ekaterinburg | |
| Russian Federation | Interregional Clinical Diagnostic Center | Kazan | |
| Russian Federation | Kazan State Medical University based at City Clinical Hospital #7 | Kazan | |
| Russian Federation | Federal State Budget Institution "Scientific-Research Institute of Complex Problems of Cardiovascular Diseases | Kemerovo | |
| Russian Federation | Medical Center Alliance | Kirovsk | |
| Russian Federation | Krasnoyarsk State Medical University n.a. prof. V.F. Voino-Yasenetsky | Krasnoyarsk | |
| 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 | City Clinical Hospital n.a. M.P. Konchalovskiy | 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 | Moscow | |
| Russian Federation | National Medical Research Center of Cardiology - Department of Atherosclerosis | 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") | Moscow | |
| Russian Federation | City Clinical Hospital No.2 | Novosibirsk | |
| Russian Federation | RC Medical LLC | Novosibirsk | |
| Russian Federation | Research Institute of Physiology and Fundamental Medicine | Novosibirsk | |
| Russian Federation | Orenburg State Medical University based at City Clinical Hospital #1 | Orenburg | |
| Russian Federation | Clinical-diagnostic center Zdorovye | Rostov-on-Don | |
| Russian Federation | Rostov-on-Don City Hospital of Emergency Care | Rostov-on-Don | |
| Russian Federation | Almazov National Medical Research Centre, Scientific Laboratory of Electrocardiology | Saint Petersburg | |
| Russian Federation | BioTechService LLC | Saint Petersburg | |
| Russian Federation | City hospital #38 n.a. N.A. Semashko | Saint Petersburg | |
| Russian Federation | Clinic Complex JSC | Saint Petersburg | |
| Russian Federation | Consultative Diagnostic Center with Out-patient Clinic | 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 | Saint-Petersburg State Budget Healthcare Institution "City Pokrovskaya Hospital", Department of Cardiology N.3 | Saint Petersburg | |
| Russian Federation | Regional Clinical Cardiology Dispensary | Saratov | |
| Russian Federation | Saratov State Medical University n. a. V.I. Razumovsky | Saratov | |
| 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 | Tomsk National Research Medical Center of Russian Academy of Sciences | Tomsk | |
| Russian Federation | Autonomous Institution of healthcare of the Voronezh region "Voronezh regional clinical consultative and diagnostic centre | Voronezh | |
| Russian Federation | Yaroslavl Regional Clinical Hospital for War Veterans - International Center on the Problems of the Elderly "Zdorovoe Dolgoletie" | Yaroslavl | |
| Ukraine | Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department | Ivano-Frankivs'k | |
| Ukraine | Kharkiv Medical Academy of Postgraduate Education | Kharkiv | |
| Ukraine | Kharkiv Railway Clinic. Hosp.#1, Branch Office of "Healthcare Center" of PJSC "Ukr. Railways", Cardiology Depart #2 | Kharkiv | |
| Ukraine | Kharkiv Railway Clinic. Hosp.#1, Branch Office of Healthcare Center of PJSC Ukr. Railways, Cardiology Depart #1 | Kharkiv | |
| Ukraine | Municipal Healthcare Institution Kharkiv City Clinical Hospital #27, Intensive Therapy Department | Kharkiv | |
| Ukraine | Municipal Healthcare Institution Kharkiv City Outpatient Clinic #9, General Practice and Family Medicine Department #1 | Kharkiv | |
| Ukraine | Municipal Non-Commercial Enterprise "City Clinical Emergency Hospital n.a. prof. O.I. Meshchaninov of Kharkiv City Council | Kharkiv | |
| 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 | 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 | Municipal Institution City Clinical Hospital #3 n.a. prof. L.J. Aleinikova, Cardiology Intensive Therapy Department | Odesa | |
| Ukraine | Small Private Enterprise, Medical Centre Puls | Vinnytsya | |
| Ukraine | Municipal Institution City Clinical Hospital #6, Therapeutic Department | Zaporizhzhia | |
| United States | Lovelace Scientific Resources | Albuquerque | New Mexico |
| United States | Clinical Research Associates of Central PA, LLC | Altoona | Pennsylvania |
| United States | Advanced Research Center | Anaheim | California |
| United States | Community Hospital of Anderson and Madison County, Inc | Anderson | Indiana |
| United States | MD First Research | Anderson | South Carolina |
| United States | MDFirst Research - Anderson | Anderson | South Carolina |
| United States | Health Innovation Research Group | Arlington | Texas |
| United States | DCT-AACT, LLC, dba Discovery Clinical Trials | Austin | Texas |
| United States | American Health Network - Avon Clinical Research Department | Avon | Indiana |
| United States | Maryland Cardiovascular Specialists | Baltimore | Maryland |
| United States | Inquest Clinical Research | Baytown | Texas |
| United States | Cahaba Research, Inc. | Birmingham | Alabama |
| United States | Central Alabama Research | Birmingham | Alabama |
| United States | Central Research Associates, Inc. | Birmingham | Alabama |
| United States | Atlantic Clinical Research Collaborative | Boynton Beach | Florida |
| United States | PMG Research of Bristol, LLC - State | Bristol | Tennessee |
| United States | Lemah Creek Clinical Research | Burr Ridge | Illinois |
| United States | Chattanooga Research & Medicine, PLLC | Chattanooga | Tennessee |
| United States | Apex Medical Research | Chicago | Illinois |
| United States | Cedar-Crosse Research Center | Chicago | Illinois |
| United States | Sterling Research Group, Ltd. - Auburn | Cincinnati | Ohio |
| United States | Aventiv Research, Inc. | Columbus | Ohio |
| United States | Columbus Regional Health | Columbus | Georgia |
| United States | ALL Medical Research, LLC | Cooper City | Florida |
| United States | Padre Coast Clinical Research | Corpus Christi | Texas |
| United States | West Broadway Clinic | Council Bluffs | Iowa |
| United States | Clinical Trials Management, LLC - Northshore | Covington | Louisiana |
| United States | Protenium Clinical Research, LLC - Dallas | Dallas | Texas |
| United States | VA North Texas Health Care System - Dallas VA Medical Center (DVAMC) | Dallas | Texas |
| United States | Alpha Research Associates, LLC | Dayton | Ohio |
| United States | iResearch | Decatur | Georgia |
| United States | Creekside Endocrine Associates, PC | Denver | Colorado |
| United States | Academy of Diabetes, Thyroid and Endocrine, P.A. | El Paso | Texas |
| United States | Medisphere Medical Research Center | Evansville | Indiana |
| United States | Lillestol Research, LLC | Fargo | North Dakota |
| United States | Aa Mrc, Llc | Flint | Michigan |
| United States | S & W Clinical Research | Fort Lauderdale | Florida |
| United States | Prestige Clinical Research | Franklin | Ohio |
| United States | Arrowhead Health Centers | Glendale | Arizona |
| United States | DeGarmo Institute Of Medical Research | Greer | South Carolina |
| United States | Lakeshore Primary Care Associate | Hamburg | New York |
| United States | Boyett Health Services Inc | Hamilton | Alabama |
| United States | Harleysville Medical Associates | Harleysville | Pennsylvania |
| United States | Desert Endocrinology Clinical Research Center | Henderson | Nevada |
| United States | Indago Research and Health Center | Hialeah | Florida |
| United States | Centex Studies, Inc. | Houston | Texas |
| United States | Juno Research, LLC | Houston | Texas |
| United States | Juno Research, LLC | Houston | Texas |
| United States | Pioneer Research Solutions Inc. | Houston | Texas |
| United States | Grace Research, LLC | Huntsville | Texas |
| United States | Longwood Research - Saadat Ansari, MD, LLC | Huntsville | Alabama |
| United States | Protenium Clinical Research, LLC | Hurst | Texas |
| United States | Midwest Institute for Clinical Research | Indianapolis | Indiana |
| United States | Jacksonville Impotence Treatment Center | Jacksonville | Florida |
| United States | Richard M.Kastelic MD and Associates | Johnstown | Pennsylvania |
| United States | Glacier View Research Institute | Kalispell | Montana |
| United States | Juno Research, LLC | Katy | Texas |
| United States | Holston Medical Group | Kingsport | Tennessee |
| United States | New Phase Research & Development | Knoxville | Tennessee |
| United States | FMC Science | Lampasas | Texas |
| United States | MD First Research | Lancaster | South Carolina |
| United States | Green and Seidner Family Practice Associates | Lansdale | Pennsylvania |
| United States | Palm Research Center, Inc. | Las Vegas | Nevada |
| United States | Physicians Research Associates, Inc | Lawrenceville | Georgia |
| United States | Kentucky Diabetes Endocrinology Center | Lexington | Kentucky |
| United States | The Research Group of Lexington, LLC | Lexington | Kentucky |
| United States | iResearch | Little Rock | Arkansas |
| United States | Lynn Institute of the Ozarks | Little Rock | Arkansas |
| United States | Pinnacle Clinical Research | Live Oak | Texas |
| United States | Torrance Clinical Research Institute Inc. | Lomita | California |
| United States | Downtown L.A. Research Center, Inc. | Los Angeles | California |
| United States | Ohio Clinical Research - Lyndhurst | Lyndhurst | Ohio |
| United States | Manassas Clinical Research Center | Manassas | Virginia |
| United States | Georgia Institute for Clinical Research | Marietta | Georgia |
| United States | Rama Research LLC | Marion | Ohio |
| United States | RAS Health Ltd | Marion | Ohio |
| United States | DCT - McAllen Primary Care, LLC | McAllen | Texas |
| United States | Solaris Clinical Research | Meridian | Idaho |
| United States | Clinical Trials Management LLC - Southshore | Metairie | Louisiana |
| United States | AMPM Research Clinic | Miami Gardens | Florida |
| United States | Catalina Research Institute, LLC | Montclair | California |
| United States | Diabetes and Endocrinology Consultants, P.C. | Morehead City | North Carolina |
| United States | Exemplar Research Inc. - Fairmont, WV | Morgantown | West Virginia |
| United States | Koch Family Medicine | Morton | Illinois |
| United States | Summit Research Group, LLC | Munroe Falls | Ohio |
| United States | Family Medicine of SayeBrook | Myrtle Beach | South Carolina |
| United States | Advanced Research Institute Inc | New Port Richey | Florida |
| United States | Mid-Hudson Medical Research, PLLC - Hopewell Junction | New Windsor | New York |
| United States | Mid-Hudson Medical Research, PLLC - New Windsor | New Windsor | New York |
| United States | Pacific Coast Cardiology and Research | Newport Beach | California |
| United States | York Clinical Research LLC | Norfolk | Virginia |
| United States | Regeneris Medical | North Attleboro | Massachusetts |
| United States | Lucita M. Cruz, MD., Inc. | Norwalk | California |
| United States | Ocala Cardiovascular Research | Ocala | Florida |
| United States | COR Clinical Research, LLC. | Oklahoma City | Oklahoma |
| United States | South Oklahoma Heart Research | Oklahoma City | Oklahoma |
| United States | Orchard Park Family Practice | Orchard Park | New York |
| United States | Research Integrity LLC | Owensboro | Kentucky |
| United States | South Florida Research Solutions LLC. | Pembroke Pines | Florida |
| United States | Phoenix Medical Research Institute, LLC | Peoria | Arizona |
| United States | Elite Clinical Studies | Phoenix | Arizona |
| United States | David M. Headley, MD P.A. | Port Gibson | Mississippi |
| United States | Progressive Medical Research | Port Orange | Florida |
| United States | Center for Medical Research, LLC | Providence | Rhode Island |
| United States | Health Concepts | Rapid City | South Dakota |
| United States | Endocrine Research Solutions, Inc | Roswell | Georgia |
| United States | Advance Clinical Research, Inc | Saint Louis | Missouri |
| United States | Consult and Research Associates | Saint Louis | Missouri |
| United States | Bandera Family HealthCare Research, LLC (BFHC) | San Antonio | Texas |
| United States | Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute | San Antonio | Texas |
| United States | San Antonio Premier Internal Medicine | San Antonio | Texas |
| United States | Integrated Research Center | San Diego | California |
| United States | Optimus Medical Group | San Francisco | California |
| United States | Cardiovascular Center of Sarasota | Sarasota | Florida |
| United States | Meridian Clinical Research - Savannah, GA | Savannah | Georgia |
| United States | Grace Research, LLC | Shreveport | Louisiana |
| United States | Clinical Research Solutions - Smyrna, TN | Smyrna | Tennessee |
| United States | Clinical Research Institute of Arizona, LLC | Surprise | Arizona |
| United States | Meridien Research | Tampa | Florida |
| United States | Meridien Research - Tampa | Tampa | Florida |
| United States | Oakland Medical Research Center | Troy | Michigan |
| United States | Terence T. Hart, MD | Tuscumbia | Alabama |
| United States | Buynak Clinical Research, P.C. | Valparaiso | Indiana |
| United States | Cardiovascular Associates, Ltd | Virginia Beach | Virginia |
| United States | Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin |
| United States | The Iowa Clinic - Cardiovascular Services | West Des Moines | Iowa |
| United States | Clinical Trials of America, LLC | West Monroe | Louisiana |
| United States | Professional Research Network of Kansas, LLC | Wichita | Kansas |
| United States | Ohio Clinical Research, LLC - Willoughby Hills | Willoughby Hills | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Kowa Research Institute, Inc. |
United States, Belarus, Bulgaria, Czechia, Georgia, Hungary, Poland, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change in Fasting TG From Baseline to Week 12 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Remnant Cholesterol | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in HDL-C | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo A1 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Non-HDL-C | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in LDL-C | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in FFAs | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo A2 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo B | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo B48 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo B100 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo C2 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo C3 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Apo E | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in FGF21 | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in hsCRP | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Large) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Intermediate) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (VLDL Cholesterol-Small) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 1) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Intermediate Density Lipoproteins 2) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins I) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIa) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIb) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIa) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IIIb) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVa) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVb) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Low Density Lipoproteins IVc) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (High Density Lipoproteins 2b) | 12 Weeks | ||
| Secondary | 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. | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 12 Weeks | ||
| Secondary | 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. | 12 Weeks | |
| Secondary | 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. | 12 Weeks | |
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Medium) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particles-Small) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (IDL Particles) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Large) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particles-Small) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Large) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Medium) | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particles-Small) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (VLDL Particle Size) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (LDL Particle Size) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (HDL Particle Size) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction (Triglyceride) | 12 Weeks | ||
| Secondary | 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. | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Lipoprotein Fraction HDL Cholesterol (Total) | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TG:HDL-C | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of TC:HDL-C | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | 12 Weeks | ||
| Secondary | Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 12 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | 12 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Fasting TG | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Remnant Cholesterol | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in HDL-C | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo A1 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Non-HDL-C | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in TC | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in LDL-C | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in FFAs | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo A2 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo B | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo B48 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo B100 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo C2 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo C3 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Apo E | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in FGF21 | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in hsCRP | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Large) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Intermediate) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (VLDL Cholesterol-Small) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 1) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Intermediate Density Lipoproteins 2) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins I) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIa) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIb) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIa) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IIIb) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVa) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVb) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Low Density Lipoproteins IVc) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (High Density Lipoproteins 2b) | 52 Weeks | ||
| Secondary | 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. | 52 Weeks | |
| Secondary | Percent Change From Baseline to Week 52 in Ion Mobility (Diameter of the Major LDL Particle (Å)) | 52 Weeks | ||
| Secondary | 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. | 52 Weeks | |
| Secondary | 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. | 52 Weeks | |
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Medium) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particles-Small) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (IDL Particles) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Large) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particles-Small) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Large) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Medium) | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particles-Small) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (VLDL Particle Size) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (LDL Particle Size) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Particle Size) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (Triglyceride) | 52 Weeks | ||
| Secondary | 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. | 52 Weeks | |
| Secondary | Percent Change From Baseline to Week 52 in Lipoprotein Fraction (HDL Cholesterol) | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TG:HDL-C | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of TC:HDL-C | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Non-HDL-C:HDL-C | 52 Weeks | ||
| Secondary | Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of LDL-C:Apo B | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo B:Apo A1 | 52 Weeks | ||
| Secondary | Percent Change From Baseline to Week 52 in Lipid and Lipoprotein Ratios of Apo C3:Apo C2 | 52 Weeks |
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