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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001817
Other study ID # K-877-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 28, 2016
Est. completion date June 24, 2019

Study information

Verified date November 2022
Source Kowa Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 551
Est. completion date June 24, 2019
Est. primary completion date June 24, 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, 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
K-877

Fenofibrate

Placebo (for K-877)

Placebo (for Fenofibrate)


Locations

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 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 UMHAT Sveti Georgi - 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 Bilina
Czechia Medicus Services SRO Brandýs nad Labem
Czechia Fakultni nemocnice Hradec Kralove, Klinika gerontologicka a metabolicka Hradec Kralove
Czechia Ordinace pro choroby srdce a cev Praha 10
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia Onkologicka klinika 2. LF UK a FN Motol 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 Balatongyorok
Hungary Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo Bekescsaba
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 Pecs
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar
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. Lodz
Poland NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek Lodz
Poland Nzoz Salusmed Lodz
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 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 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 Saint-Petersburg
Russian Federation Regional Clinical Cardiology Dispensary Saratov
Russian Federation Saratov State Medical University n. a. V.I. Razumovsky Saratov
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 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
Russian Federation City Clinical Hospital n.a. M.P. Konchalovskiy Zelenograd Moscow
Ukraine Ivano-Frankivsk Regional Clinical Cardiological Dispensary, Chronic Ischaemic Heart Disease Department Ivano-Frankivsk
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 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 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 Specialist 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 Apex Medical Research - Illinois 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 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 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 Henderson Nevada
United States Indago Research and Health Center Hialeah Florida
United States Centex Studies, Inc. Houston Texas
United States Juno Research, LLC - Northwest Site Houston Texas
United States Juno Research, LLC - Southwest Houston Site Houston Texas
United States Pioneer Research Solutions Inc. Houston Texas
United States Grace Research, LLC - Huntsville, TX 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 Katy Texas
United States New Phase Research & Development - Knoxville Knoxville Tennessee
United States FMC Science Lampasas Texas
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 The Research Group of Lexington, LLC Lexington Kentucky
United States iResearch - Little Rock Little Rock Arkansas
United States Lynn Institute of the Ozarks Little Rock Arkansas
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 Lemah Creek Clinical Research Melrose Park Illinois
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 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 York Clinical Research LLC Norfolk Virginia
United States Lucita M. Cruz, MD., Inc. Norwalk California
United States Ocala Cardiovascular Research Ocala Florida
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 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 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 Pinnacle Clinical Research San Antonio Texas
United States San Antonio Premier Internal Medicine San Antonio Texas
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Meridian Clinical Research - Savannah, GA Savannah Georgia
United States Clinical Research Solutions - Smyrna, TN Smyrna Tennessee
United States Clinical Research Institute of Arizona, LLC Surprise Arizona
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 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, LA West Monroe Louisiana
United States Professional Research Network of Kansas, LLC Wichita Kansas
United States Ohio Clinical Research, LLC - Willoughby Hills Willoughby Hills Ohio

Sponsors (1)

Lead Sponsor Collaborator
Kowa Research Institute, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Bulgaria,  Czechia,  Georgia,  Hungary,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change of Fasting Triglyceride(TG) Levels 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 Free Fatty Acids (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 Fibroblast Growth Factor 21 (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 - Very Low-Density Lipoprotein (VLDL) Cholesterol-Large 12 Weeks
Secondary Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (VLDL) Cholesterol-Intermediate 12 Weeks
Secondary Percent Change From Baseline to Week 12 in Ion Mobility - Very Low-Density Lipoprotein (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 - Major LDL Particle Measurement 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 Percent 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 Change From Baseline to Week 12 in Lipoprotein Fraction - LDL Particles (Total) 12 Weeks
Secondary Change From Baseline to Week 12 in Lipoprotein Fraction - Intermediate-density Lipoprotein (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 (Total) 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 Percent 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 (Total) 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 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 Total Cholesterol (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 Percent 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 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 Percent 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 Change From Baseline to Week 52 in Lipoprotein Fraction - LDL Particles (Total) 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 Percent 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 Percent 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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