Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)

A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy

The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Diseases
• Intervention / Treatment: Drug: ETC-1002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2230
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
    • Victoria, British Columbia, Canada
  • Ontario
    • Gatineau, Ontario, Canada
    • Mississauga, Ontario, Canada
    • Oshawa, Ontario, Canada
    • Peterborough, Ontario, Canada
    • Scarborough, Ontario, Canada
  • Quebec
    • Chicoutimi, Quebec, Canada
    • Gatineau, Quebec, Canada
    • Longueuil, Quebec, Canada
    • Montréal, Quebec, Canada
    • Québec, Quebec, Canada
    • Saint-Jean-Sur-Richelieu, Quebec, Canada
    • St-Charles-Borromee, Quebec, Canada
• Germany
  • Berlin, Germany
  • Bochum, Germany
  • Dresden, Germany
  • Essen, Germany
  • Frankfurt, Germany
  • Leipzig, Germany
  • Muenchen, Germany
• Netherlands
  • Amsterdam, Netherlands
  • Arnhem, Netherlands
  • Eindhoven, Netherlands
  • Goes, Netherlands
  • Groningen, Netherlands
  • Hardenberg, Netherlands
  • Leiden, Netherlands
  • Rotterdam, Netherlands
  • Tilburg, Netherlands
  • Venlo, Netherlands
  • Zutphen, Netherlands
• Poland
  • Gdansk, Poland
  • Gdynia, Poland
  • Katowice, Poland
  • Kraków, Poland
  • Poznań, Poland
  • Puławy, Poland
  • Toruń, Poland
  • Wroclaw, Poland
  • Łowicz, Poland
  • Łódź, Poland
• United Kingdom
  • Bexhill-on-Sea, United Kingdom
  • Birmingham, United Kingdom
  • Cardiff, United Kingdom
  • Chesterfield, United Kingdom
  • Chichester, United Kingdom
  • Chippenham, United Kingdom
  • Chorley, United Kingdom
  • Glasgow, United Kingdom
  • Hexham, United Kingdom
  • Hull, United Kingdom
  • Ipswich, United Kingdom
  • Liverpool, United Kingdom
  • Manchester, United Kingdom
  • Reading, United Kingdom
• United States
  • Alabama
    • Huntsville, Alabama, United States
  • Arizona
    • Cottonwood, Arizona, United States
    • Phoenix, Arizona, United States
  • California
    • Canoga Park, California, United States
    • Santa Rosa, California, United States
  • Connecticut
    • Bridgeport, Connecticut, United States
    • Hartford, Connecticut, United States
  • Florida
    • Atlantis, Florida, United States
    • Boca Raton, Florida, United States
    • Crestview, Florida, United States
    • Crystal River, Florida, United States
    • Daytona Beach, Florida, United States
    • Lake Worth, Florida, United States
    • Miami Lakes, Florida, United States
    • Tampa, Florida, United States
  • Illinois
    • Park Ridge, Illinois, United States
  • Iowa
    • Iowa City, Iowa, United States
  • Kansas
    • Overland Park, Kansas, United States
  • Kentucky
    • Covington, Kentucky, United States
    • Louisville, Kentucky, United States
  • Louisiana
    • Minden, Louisiana, United States
    • Monroe, Louisiana, United States
    • Shreveport, Louisiana, United States
  • Maine
    • Auburn, Maine, United States
  • Michigan
    • Midland, Michigan, United States
    • Saginaw, Michigan, United States
  • Minnesota
    • Saint Cloud, Minnesota, United States
  • Mississippi
    • Tupelo, Mississippi, United States
  • Missouri
    • Jefferson City, Missouri, United States
  • New Hampshire
    • Nashua, New Hampshire, United States
  • New Jersey
    • Bridgewater, New Jersey, United States
  • North Carolina
    • Cary, North Carolina, United States
    • Mount Airy, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Rocky Mount, North Carolina, United States
    • Wilmington, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Sandusky, Ohio, United States
    • Willoughby, Ohio, United States
  • Oregon
    • Hillsboro, Oregon, United States
  • Texas
    • Fort Worth, Texas, United States
    • Houston, Texas, United States
    • Katy, Texas, United States
    • Kingwood, Texas, United States
  • Utah
    • Orem, Utah, United States
  • Virginia
    • Richmond, Virginia, United States
  • Washington
    • Puyallup, Washington, United States
    • Tacoma, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fasting LDL-C ≥ 70 mg/dL
• High cardiovascular risk (diagnosis of HeFH or ASCVD)
• Be on maximally tolerated lipid-modifying therapy

Exclusion Criteria:

• Total fasting triglyceride ≥500 mg/dL
• Renal dysfunction or nephrotic syndrome or history of nephritis
• Body Mass Index (BMI) ≥50kg/m2
• Significant cardiovascular disease or cardiovascular event in the past 3 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo control	Drug: Placebo; Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Experimental: ETC-1002; ETC-1002 180 mg/day	Drug: ETC-1002; ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided); Other Names: bempedoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	TEAEs, defined as adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported.	Up to approximately 52 weeks
Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event	TEAEs, defined as AEs that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. Cardiovascular events were considered as adverse events of special interest. Treatment-emergent = TE.	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations	TEAEs of special interest (AESIs) were predefined and monitored throughout the study. Creatine kinase elevations were assessed using the following preferred term: Blood creatine phosphokinase increased (system organ class: investigations).	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders	Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to hepatic events were assessed using the following preferred terms and laboratory abnormalities: aspartate aminotransferase (AST) increased, Alanine aminotransferase (ALT) increased, Hepatic enzyme increased, Blood bilirubin increased, liver function test (LFT) abnormal, LFT increased, hepatic enzyme abnormal, transaminases increased, potential Hy's Law cases (PHLC) [AST and (&)/or ALT >3 x upper limit of normal (ULN) with concurrent total bilirubin >2 x ULN], AST and/or ALT >3 x ULN, and total bilirubin >2 x ULN (system organ class: investigations). AST and ALT values were repeated and confirmed. "Repeated and confirmed" was defined as a participant having the last on-study LFT > x ULN, the last on-treatment LFT > x ULN, or LFT > x ULN followed by another LFT > x ULN.	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia	Treatment-emergent AESIs were predefined and monitored throughout the study. Hypoglycemia was assessed using the following preferred terms: hypoglycaemia (system organ class: metabolism and nutrition disorders); blood glucose abnormal and blood glucose decreased (system organ class: investigations). The percentage of unique participants is reported in the "Overall hypoglycemia AESIs" category; a participant could have been represented in more than one of the individual hypoglycemia AESIs.	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis	Treatment-emergent AESIs were predefined and monitored throughout the study. Metabolic acidosis was assessed using the preferred term metabolic acidosis (system organ class: metabolism and nutrition disorders).	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder	Treatment-emergent AESIs were predefined and monitored throughout the study. Muscular safety was assessed using the following preferred terms and laboratory abnormalities: myalgia, muscle spasms, pain in extremity, muscular weakness (system organ class: musculoskeletal and connective tissue disorders), and creatine kinase >5 ULN (repeated and confirmed). The percentage of unique participants is reported in the "Overall muscular disorder AESIs" category; a participant could have been represented in more than one of the individual muscular disorder AESIs.	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder	Treatment-emergent AESIs were predefined and monitored throughout the study. Neurocognitive disorder was assessed using the following preferred terms: memory impairment, amnesia, and cognitive disorder (system organ class: nervous system disorders); confusional state and disorientation (system organ class: psychiatric disorders). The percentage of unique participants is reported in the "Overall neurocognitive disorder AESIs" category; a participant could have been represented in more than one of the individual neurocognitive disorder AESIs.	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus	Treatment-emergent AESIs were predefined and monitored throughout the study. New onset or worsening diabetes was assessed using the following preferred terms: type 2 diabetes mellitus, diabetes mellitus, hyperglycaemia, glucose tolerance impaired, diabetes mellitus inadequate control, and impaired fasting glucose (system organ class: metabolism and nutrition disorders); blood glucose increased, glycosylated haemoglobin increased, blood glucose abnormal, and glucose urine present (system organ class: investigations); and glycosuria (system organ class: renal and urinary disorders). The percentage of unique participants is reported in the "Overall new onset/worsening diabetes mellitus AESIs" category; a participant could have been represented in more than one of the individual new onset/worsening diabetes mellitus AESIs.	Up to approximately 52 weeks
Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder	Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to renal events were assessed using the following preferred terms: renal failure, renal impairment, acute kidney injury (system organ class: renal and urinary disorders); blood creatinine increased, glomerular filtration rate decreased, blood urea increased, estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (ml/min/1.73m^2), and change from baseline in creatinine >1 mg/dL (system organ class: investigations); and gout (system organ class: metabolism and nutrition disorders). The percentage of unique participants is reported in the "Overall renal disorder AESIs" category; a participant could have been represented in more than one of the individual renal disorder AESIs.	Up to approximately 52 weeks
Change From Baseline to Week 52 in Uric Acid (Urate) Level	Blood samples were drawn at defined time points during the course of the study to monitor uric acid (urate) levels.	Baseline and Week 52
Change From Baseline to Week 52 in Creatinine Level	Blood samples were drawn at defined time points during the course of the study to monitor creatinine levels.	Baseline and Week 52
Change From Baseline to Week 52 in Hemoglobin Level	Blood samples were drawn at defined time points during the course of the study to monitor hemoglobin levels.	Baseline and Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Least Square mean= LS mean. Percent change was analyzed using the analysis of covariance (ANCOVA) method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 12
Absolute Change From Baseline to Week 12 in LDL-C	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Absolute change from baseline was calculated as: LDL-C value at Week 12 minus Baseline value. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen.	Baseline; Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to Week 24 in LDL-C	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 24
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 12
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB)	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 12
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 12
Percent Change From Baseline to Week 52 in LDL-C	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.	Baseline; Week 52
Percent Change From Baseline to Week 24 in Non-HDL-C	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 24
Percent Change From Baseline to Week 52 in Non-HDL-C	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 52
Percent Change From Baseline to Week 24 in TC	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 24
Percent Change From Baseline to Week 52 in TC	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 52
Percent Change From Baseline to Week 24 in apoB	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed	Baseline; Week 24
Percent Change From Baseline to Week 52 in apoB	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 52
Percent Change From Baseline to Week 24 in hsCRP	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 24
Percent Change From Baseline to Week 52 in hsCRP	Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.	Baseline; Week 52
Percentage of Participants Achieving LDL-C <70 mg/dL at Week 12, 24, and 52	The percentage of participants who achieved lowering in lipid values of LDL-C below 70 mg/dL have been reported. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Observed data was used for the analysis, no imputation for the missing data was performed.	Week 12, Week 24, and Week 52

Collaborators and Investigators

• Sponsor: Esperion Therapeutics, Inc.

Publications and helpful links

General Publications

• Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
• Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Circulation. 2015 Dec 22;132(25):e396.
• Goldberg AC, Hopkins PN, Toth PP, Ballantyne CM, Rader DJ, Robinson JG, Daniels SR, Gidding SS, de Ferranti SD, Ito MK, McGowan MP, Moriarty PM, Cromwell WC, Ross JL, Ziajka PE; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S1-8. doi: 10.1016/j.jacl.2011.04.003. Epub 2011 Apr 12.
• Pollex RL, Joy TR, Hegele RA. Emerging antidyslipidemic drugs. Expert Opin Emerg Drugs. 2008 Jun;13(2):363-81. doi: 10.1517/14728214.13.2.363.
• Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13. doi: 10.1161/hc3501.095214.
• Ballantyne CM, Bays HE, Louie MJ, Smart J, Zhang Y, Ray KK. Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid. J Am Heart Assoc. 2022 Aug 2;11(15):e024531. doi: 10.1161/JAHA.121.024531. Epub 2022 Aug 2.
• Banach M, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Flaim J, Ye Z, Catapano AL. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020 Oct 1;5(10):1124-1135. doi: 10.1001/jamacardio.2020.2314.
• Ray KK, Bays HE, Catapano AL, Lalwani ND, Bloedon LT, Sterling LR, Robinson PL, Ballantyne CM; CLEAR Harmony Trial. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019 Mar 14;380(11):1022-1032. doi: 10.1056/NEJMoa1803917.

Helpful Links

• World Health Organization Fact Sheet No. 317
• National Organization for Rare Disorders - Familial Hypercholesterolemia
• Familial Hypercholesterolemia Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2016
• Primary Completion (Actual): February 21, 2018
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: cholesterol; hyperlipidemia; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis; Hyperlipidemias; Hyperlipoproteinemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
• Other Study ID Numbers: 1002-040; 2015-004136-36 (EudraCT Number)