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

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, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001817
• Other study ID #: K-877-301
• Status: Completed
• Phase: Phase 3
• 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
• 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);

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Severe Hypertriglyceridemia

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