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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02666664
Recruitment Status : Completed
First Posted : January 28, 2016
Results First Posted : April 20, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypercholesterolemia
Atherosclerotic Cardiovascular Diseases
Interventions Drug: ETC-1002
Drug: Placebo
Enrollment 2230
Recruitment Details A total of 2230 participants were randomized 2:1 to either bempedoic acid or placebo. One participant was randomized to bempedoic acid treatment, but never received any dose of investigational medicinal product (IMP) i.e. study drug.
Pre-assignment Details The study consisted of 2 periods: a 2-week screening period and a 52-week double-blind, randomized treatment period.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Period Title: Overall Study
Started 742 1488
Completed 706 1404
Not Completed 36 84
Reason Not Completed
Physician Decision             0             1
Protocol Violation             0             2
Other             0             1
Adverse Event             12             37
Withdrawal by participant             23             40
Sponsor decision             0             1
Lost to Follow-up             1             2
Arm/Group Title Placebo Bempedoic Acid Total
Hide Arm/Group Description During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 742 1488 2230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 742 participants 1488 participants 2230 participants
66.8  (8.64) 65.8  (9.11) 66.1  (8.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Female
213
  28.7%
389
  26.1%
602
  27.0%
Male
529
  71.3%
1099
  73.9%
1628
  73.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Hispanic or Latino
11
   1.5%
24
   1.6%
35
   1.6%
Not Hispanic or Latino
731
  98.5%
1464
  98.4%
2195
  98.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
American Indian or Alaska Native
1
   0.1%
2
   0.1%
3
   0.1%
Asian
8
   1.1%
14
   0.9%
22
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.1%
2
   0.1%
Black or African American
15
   2.0%
42
   2.8%
57
   2.6%
White
716
  96.5%
1423
  95.6%
2139
  95.9%
More than one race
0
   0.0%
1
   0.1%
1
   0.0%
Unknown or Not Reported
2
   0.3%
4
   0.3%
6
   0.3%
Cardiovascular history: atherosclerotic cardiovascular disease (ASCVD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
727
  98.0%
1449
  97.4%
2176
  97.6%
No
15
   2.0%
39
   2.6%
54
   2.4%
Cardiovascular history: heterozygous familial hypercholesterolemia (HeFH)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
23
   3.1%
56
   3.8%
79
   3.5%
No
719
  96.9%
1432
  96.2%
2151
  96.5%
History of diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
212
  28.6%
425
  28.6%
637
  28.6%
No
530
  71.4%
1063
  71.4%
1593
  71.4%
History of hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
594
  80.1%
1174
  78.9%
1768
  79.3%
No
148
  19.9%
314
  21.1%
462
  20.7%
Concomitant lipid-modifying therapy (LMT): Statin   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
742
 100.0%
1485
  99.8%
2227
  99.9%
No
0
   0.0%
3
   0.2%
3
   0.1%
[1]
Measure Description: Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug.
Concomitant LMT: Ezetimibe   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
56
   7.5%
116
   7.8%
172
   7.7%
No
686
  92.5%
1372
  92.2%
2058
  92.3%
[1]
Measure Description: Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug.
Concomitant LMT: Fibrate   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Yes
26
   3.5%
54
   3.6%
80
   3.6%
No
716
  96.5%
1434
  96.4%
2150
  96.4%
[1]
Measure Description: Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug.
Concomitant LMT: None   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Concomitant LMT: None
0
   0.0%
2
   0.1%
2
   0.1%
Concomitant LMT: Yes
742
 100.0%
1486
  99.9%
2228
  99.9%
[1]
Measure Description: Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug.
Baseline statin intensity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Low
48
   6.5%
100
   6.7%
148
   6.6%
Moderate
324
  43.7%
646
  43.4%
970
  43.5%
High
370
  49.9%
742
  49.9%
1112
  49.9%
[1]
Measure Description: Baseline statin intensity were based on stratification at randomization. Low-intensity statins: simvastatin 10 milligrams (mg); pravastatin 10-20 mg; lovastatin 20 mg; fluvastatin 20-40 mg; pitavastatin 1 mg. Moderate-intensity statins: atorvastatin 10-20 mg; rosuvastatin 5-10 mg; simvastatin 20 mg; pravastatin 40-80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg twice a day; pitavastatin 2-4 mg. High-intensity statins: atorvastatin 40-80 mg; rosuvastatin 20-40 mg.
Estimated glomerular filtration rate (eGFR)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 1488 participants 2230 participants
Normal: ≥ 90 mL/min/1.73m^2
167
  22.5%
320
  21.5%
487
  21.8%
Mild Renal Impairment: 60-89 mL/min/1.73m^2
468
  63.1%
946
  63.6%
1414
  63.4%
Moderate Renal Impairment: 30-59 mL/min/1.73m^2
107
  14.4%
222
  14.9%
329
  14.8%
[1]
Measure Description: milliliter per minute per 1.73 square meter = ml/min/1.73m^2
Total cholesterol (TC)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 742 participants 1488 participants 2230 participants
178.64  (35.645) 179.66  (35.143) 179.32  (35.306)
[1]
Measure Description: Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1).
Low-density lipoprotein cholesterol (LDL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 742 participants 1488 participants 2230 participants
102.30  (30.048) 103.60  (29.127) 103.16  (29.436)
[1]
Measure Description: Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1).
High-density lipoprotein cholesterol (HDL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 742 participants 1488 participants 2230 participants
49.29  (11.545) 48.71  (11.853) 48.90  (11.752)
[1]
Measure Description: Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1).
Triglycerides (TG)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 742 participants 1488 participants 2230 participants
122.50
(95.50 to 169.50)
126.25
(98.00 to 165.50)
125.00
(97.50 to 167.00)
[1]
Measure Description: Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1).
Non-high-density lipoprotein cholesterol (non-HDL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 742 participants 1488 participants 2230 participants
129.37  (33.855) 130.92  (33.677) 130.41  (33.737)
[1]
Measure Description: Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1).
Apolipoprotein B (apoB)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 742 participants 1488 participants 2230 participants
86.8  (21.82) 88.5  (21.57) 87.9  (21.66)
[1]
Measure Description: Baseline was defined as the last value prior to first dose of study drug.
High-sensitivity C-reactive protein (hsCRP)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/L
Number Analyzed 742 participants 1488 participants 2230 participants
1.51
(0.79 to 3.33)
1.49
(0.74 to 3.28)
1.49
(0.76 to 3.30)
[1]
Measure Description: Baseline was defined as the last value prior to the first dose of study drug.
1.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least 1 dose of investigational medicinal product. Participants were included in the treatment group that they received, regardless of their randomized treatment.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 78.7 78.5
Any serious TEAE 14.0 14.5
Any fatal TEAE 0.3 0.9
Any TEAE leading to discontinuation of study drug 7.1 10.9
2.Primary Outcome
Title Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Any adjudicated major clinical event 5.7 4.6
Any TE death from cardiovascular causes 0.1 0.4
Any nonfatal myocardial infarction 1.8 1.3
Any nonfatal stroke 0.3 0.3
Any coronary revascularization 3.2 2.6
Any hospitalization for unstable angina 1.5 0.9
TE death from noncardiovascular causes 0.1 0.1
Noncoronary arterial revascularization 0.8 0.3
Hospitalization for heart failure 0.1 0.6
3.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations
Hide Description 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).
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
1.8 2.4
4.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. The percentage of unique participants is reported in the "Overall hepatic disorder AESIs" category; a participant could have been represented in more than one of the individual hepatic disorder AESIs.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Overall hepatic disorder AESIs 1.5 2.5
AST increased 0.4 1.5
ALT increased 0.3 0.8
Hepatic enzyme increased 0.0 0.5
Blood bilirubin increased 0.4 0.1
Liver function test abnormal 0.3 0.1
Liver function test increased 0.1 0.2
Hepatic enzyme abnormal 0.0 0.1
Transaminases increased 0.1 0.0
PHLC [AST &/or ALT>3 x ULN, concurrent TB>2 x ULN] 0.0 0.0
AST and/or ALT >3 x ULN 0.1 0.5
Total bilirubin >2 x ULN 0.0 0.0
5.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Overall hypoglycemia AESIs 3.1 2.2
Hypoglycaemia 3.0 2.2
Blood glucose abnormal 0.1 0.1
Blood glucose decreased 0.0 0.1
6.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis
Hide Description 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).
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.1
7.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Overall muscular disorder AESIs 10.1 13.1
Myalgia 6.1 6.0
Muscle spasms 2.7 4.2
Pain in extremity 2.2 3.4
Muscular weakness 0.5 0.6
Creatine kinase >5 ULN 0.1 0.5
8.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Overall neurocognitive disorder AESIs 0.9 0.7
Memory impairment 0.5 0.3
Amnesia 0.4 0.2
Cognitive disorder 0.0 0.1
Confusional state 0.0 0.1
Disorientation 0.0 0.1
9.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Overall new onset/worsening diabetes mellitus AESI 5.4 3.3
Type 2 diabetes mellitus 0.9 1.0
Diabetes mellitus 0.9 0.4
Hyperglycaemia 0.7 0.5
Glucose tolerance impaired 0.1 0.4
Diabetes mellitus inadequate control 0.4 0.1
Impaired fasting glucose 0.3 0.1
Blood glucose increased 1.2 0.7
Glycosylated haemoglobin increased 0.5 0.0
Blood glucose abnormal 0.1 0.1
Glucose urine present 0.1 0.0
Glycosuria 0.3 0.1
10.Primary Outcome
Title Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder
Hide Description 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.
Time Frame Up to approximately 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Measure Type: Number
Unit of Measure: percentage of participants
Renal failure 0.1 0.9
Renal impairment 0.1 0.4
Acute kidney injury 0.3 0.3
Blood creatinine increased 0.4 0.8
Glomerular filtration rate decreased 0.0 0.5
Blood urea increased 0.1 0.1
Gout 0.3 1.2
Change from baseline in creatinine >1 mg/dL 0.0 0.1
eGFR <30 mL/min/1.73 m^2 0.4 0.9
11.Primary Outcome
Title Change From Baseline to Week 52 in Uric Acid (Urate) Level
Hide Description Blood samples were drawn at defined time points during the course of the study to monitor uric acid (urate) levels.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter (mg/dL)
Baseline Number Analyzed 742 participants 1487 participants
5.96  (1.35) 6.06  (1.37)
Change from Baseline at Week 52 Number Analyzed 680 participants 1358 participants
-0.06  (0.87) 0.73  (1.11)
12.Primary Outcome
Title Change From Baseline to Week 52 in Creatinine Level
Hide Description Blood samples were drawn at defined time points during the course of the study to monitor creatinine levels.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 742 participants 1487 participants
0.96  (0.22) 0.97  (0.22)
Change from Baseline at Week 52 Number Analyzed 677 participants 1343 participants
-0.02  (0.12) 0.02  (0.13)
13.Primary Outcome
Title Change From Baseline to Week 52 in Hemoglobin Level
Hide Description Blood samples were drawn at defined time points during the course of the study to monitor hemoglobin levels.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1487
Mean (Standard Deviation)
Unit of Measure: grams per deciliter (g/dL)
Baseline Number Analyzed 742 participants 1487 participants
14.07  (1.26) 14.22  (1.26)
Change from Baseline at Week 52 Number Analyzed 669 participants 1334 participants
-0.23  (0.85) -0.58  (0.88)
14.Secondary Outcome
Title Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description 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.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all randomized participants
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1488
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.6  (0.86) -16.5  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -18.1
Confidence Interval (2-Sided) 95%
-20 to -16.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.01
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Absolute Change From Baseline to Week 12 in LDL-C
Hide Description 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.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 725 1424
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.43  (27.04) -19.23  (24.01)
16.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 24 in LDL-C
Hide Description 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.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1488
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.2  (0.88) -14.9  (0.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -16.1
Confidence Interval (2-Sided) 95%
-18.2 to -14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.07
Estimation Comments [Not Specified]
17.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Hide Description 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.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1488
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.5  (0.76) -11.9  (0.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -13.3
Confidence Interval (2-Sided) 95%
-15.1 to -11.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments [Not Specified]
18.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
Hide Description 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.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1488
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.8  (0.57) -10.3  (0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -11.1
Confidence Interval (2-Sided) 95%
-12.5 to -9.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
19.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB)
Hide Description 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.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 736 1485
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.3  (0.70) -8.6  (0.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -11.9
Confidence Interval (2-Sided) 95%
-13.6 to -10.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.85
Estimation Comments [Not Specified]
20.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
Hide Description 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.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 724 1421
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.6  (91.9) -22.4  (72.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Location shift
Estimated Value -21.5
Confidence Interval (2-Sided) 95%
-26.96 to -16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.8
Estimation Comments [Not Specified]
21.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in LDL-C
Hide Description 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.
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 685 1364
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.0  (0.92) -12.6  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -13.6
Confidence Interval (2-Sided) 95%
-15.8 to -11.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.13
Estimation Comments [Not Specified]
22.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 24 in Non-HDL-C
Hide Description 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.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 707 1396
Mean (Standard Deviation)
Unit of Measure: percent change
1.61  (20.91) -11.69  (19.80)
23.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in Non-HDL-C
Hide Description 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.
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 685 1364
Mean (Standard Deviation)
Unit of Measure: percent change
0.65  (21.438) -10.07  (22.097)
24.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 24 in TC
Hide Description 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.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 708 1396
Mean (Standard Deviation)
Unit of Measure: percent change
1.15  (15.349) -9.86  (15.358)
25.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in TC
Hide Description 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.
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 685 1365
Mean (Standard Deviation)
Unit of Measure: percent change
0.38  (16.180) -8.92  (16.945)
26.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 24 in apoB
Hide Description 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
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 699 1381
Mean (Standard Deviation)
Unit of Measure: percent change
4.8  (20.41) -7.1  (20.01)
27.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in apoB
Hide Description 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.
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 676 1342
Mean (Standard Deviation)
Unit of Measure: percent change
3.4  (20.24) -6.0  (22.54)
28.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 24 in hsCRP
Hide Description 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.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 706 1392
Median (Inter-Quartile Range)
Unit of Measure: percent change
2.727
(-33.028 to 59.016)
-16.382
(-51.329 to 34.436)
29.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in hsCRP
Hide Description 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.
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 681 1358
Median (Inter-Quartile Range)
Unit of Measure: percent change
1.818
(-36.508 to 60.952)
-14.445
(-50.000 to 43.889)
30.Other Pre-specified Outcome
Title Percentage of Participants Achieving LDL-C <70 mg/dL at Week 12, 24, and 52
Hide Description 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.
Time Frame Week 12, Week 24, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Only participants with available data were analyzed.
Arm/Group Title Placebo Bempedoic Acid
Hide Arm/Group Description:
During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
Overall Number of Participants Analyzed 742 1488
Measure Type: Number
Unit of Measure: Percentage of participants
Week 12 Number Analyzed 725 participants 1424 participants
9.0 32.4
Week 24 Number Analyzed 707 participants 1397 participants
10.2 32.0
Week 52 Number Analyzed 685 participants 1364 participants
9.5 28.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bempedoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Up to approximately 52 weeks
Adverse Event Reporting Description Treatment-emergent adverse events (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.
 
Arm/Group Title Bempedoic Acid Placebo
Hide Arm/Group Description During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study.
All-Cause Mortality
Bempedoic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/1487 (0.87%)   2/742 (0.27%) 
Hide Serious Adverse Events
Bempedoic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   216/1487 (14.53%)   104/742 (14.02%) 
Blood and lymphatic system disorders     
Anaemia  1  2/1487 (0.13%)  1/742 (0.13%) 
Cardiac disorders     
Acute left ventricular failure  1  1/1487 (0.07%)  0/742 (0.00%) 
Acute coronary syndrome  1  0/1487 (0.00%)  2/742 (0.27%) 
Acute myocardial infarction  1  11/1487 (0.74%)  5/742 (0.67%) 
Angina pectoris  1  11/1487 (0.74%)  6/742 (0.81%) 
Angina unstable  1  18/1487 (1.21%)  12/742 (1.62%) 
Aortic valve incompetence  1  1/1487 (0.07%)  0/742 (0.00%) 
Arrhythmia  1  0/1487 (0.00%)  1/742 (0.13%) 
Atrial fibrillation  1  7/1487 (0.47%)  1/742 (0.13%) 
Arteriospasm coronary  1  1/1487 (0.07%)  0/742 (0.00%) 
Atrial flutter  1  1/1487 (0.07%)  2/742 (0.27%) 
Atrial tachycardia  1  1/1487 (0.07%)  0/742 (0.00%) 
Atrioventricular block complete  1  0/1487 (0.00%)  1/742 (0.13%) 
Atrioventricular block second degree  1  1/1487 (0.07%)  0/742 (0.00%) 
Cardiac arrest  1  1/1487 (0.07%)  1/742 (0.13%) 
Bradycardia  1  2/1487 (0.13%)  0/742 (0.00%) 
Cardiac failure  1  5/1487 (0.34%)  3/742 (0.40%) 
Cardiac failure acute  1  0/1487 (0.00%)  1/742 (0.13%) 
Cardiac failure congestive  1  4/1487 (0.27%)  1/742 (0.13%) 
Coronary artery disease  1  9/1487 (0.61%)  6/742 (0.81%) 
Hypertensive heart disease  1  1/1487 (0.07%)  0/742 (0.00%) 
Ischaemic cardiomyopathy  1  1/1487 (0.07%)  0/742 (0.00%) 
Left ventricular dilatation  1  1/1487 (0.07%)  0/742 (0.00%) 
Myocardial ischaemia  1  4/1487 (0.27%)  1/742 (0.13%) 
Myocardial infarction  1  8/1487 (0.54%)  5/742 (0.67%) 
Pericarditis  1  2/1487 (0.13%)  0/742 (0.00%) 
Sinus node dysfunction  1  2/1487 (0.13%)  0/742 (0.00%) 
Supraventricular tachycardia  1  2/1487 (0.13%)  0/742 (0.00%) 
Ventricular fibrillation  1  2/1487 (0.13%)  1/742 (0.13%) 
Ventricular tachycardia  1  2/1487 (0.13%)  1/742 (0.13%) 
Left ventricular failure  1  1/1487 (0.07%)  0/742 (0.00%) 
Congenital, familial and genetic disorders     
Myotonic dystrophy  1  1/1487 (0.07%)  0/742 (0.00%) 
Endocrine disorders     
Goitre  1  1/1487 (0.07%)  0/742 (0.00%) 
Hyperparathyroidism primary  1  1/1487 (0.07%)  0/742 (0.00%) 
Eye disorders     
Retinal detachment  1  1/1487 (0.07%)  0/742 (0.00%) 
Cataract  1  1/1487 (0.07%)  1/742 (0.13%) 
Gastrointestinal disorders     
Constipation  1  1/1487 (0.07%)  0/742 (0.00%) 
Abdominal hernia  1  1/1487 (0.07%)  0/742 (0.00%) 
Diarrhoea  1  1/1487 (0.07%)  0/742 (0.00%) 
Diverticular perforation  1  0/1487 (0.00%)  1/742 (0.13%) 
Duodenal ulcer  1  0/1487 (0.00%)  1/742 (0.13%) 
Enteritis  1  0/1487 (0.00%)  1/742 (0.13%) 
Gastritis  1  2/1487 (0.13%)  0/742 (0.00%) 
Gastrointestinal haemorrhage  1  1/1487 (0.07%)  0/742 (0.00%) 
Inguinal hernia  1  1/1487 (0.07%)  1/742 (0.13%) 
Internal hernia  1  1/1487 (0.07%)  0/742 (0.00%) 
Large intestine polyp  1  1/1487 (0.07%)  0/742 (0.00%) 
Mallory-Weiss syndrome  1  1/1487 (0.07%)  0/742 (0.00%) 
Obstructive pancreatitis  1  1/1487 (0.07%)  1/742 (0.13%) 
Pancreatitis acute  1  2/1487 (0.13%)  0/742 (0.00%) 
Pancreatic pseudocyst  1  1/1487 (0.07%)  0/742 (0.00%) 
Rectal haemorrhage  1  0/1487 (0.00%)  1/742 (0.13%) 
Pancreatitis relapsing  1  1/1487 (0.07%)  0/742 (0.00%) 
Umbilical hernia  1  1/1487 (0.07%)  1/742 (0.13%) 
Small intestinal obstruction  1  0/1487 (0.00%)  1/742 (0.13%) 
Upper gastrointestinal haemorrhage  1  1/1487 (0.07%)  1/742 (0.13%) 
Abdominal pain  1  1/1487 (0.07%)  0/742 (0.00%) 
General disorders     
Asthenia  1  1/1487 (0.07%)  1/742 (0.13%) 
Chest discomfort  1  1/1487 (0.07%)  1/742 (0.13%) 
Chest pain  1  1/1487 (0.07%)  1/742 (0.13%) 
Death  1  0/1487 (0.00%)  1/742 (0.13%) 
Eye complication associated with device  1  0/1487 (0.00%)  1/742 (0.13%) 
Granuloma  1  1/1487 (0.07%)  0/742 (0.00%) 
Gait disturbance  1  1/1487 (0.07%)  0/742 (0.00%) 
Hernia  1  1/1487 (0.07%)  0/742 (0.00%) 
Multiple organ dysfunction syndrome  1  1/1487 (0.07%)  0/742 (0.00%) 
Pelvic mass  1  0/1487 (0.00%)  1/742 (0.13%) 
Non-cardiac chest pain  1  7/1487 (0.47%)  4/742 (0.54%) 
Vascular stent restenosis  1  1/1487 (0.07%)  0/742 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/1487 (0.00%)  1/742 (0.13%) 
Cholecystitis  1  3/1487 (0.20%)  0/742 (0.00%) 
Cholelithiasis  1  3/1487 (0.20%)  1/742 (0.13%) 
Jaundice  1  1/1487 (0.07%)  0/742 (0.00%) 
Portal vein thrombosis  1  1/1487 (0.07%)  0/742 (0.00%) 
Immune system disorders     
Immune system disorder  1  1/1487 (0.07%)  0/742 (0.00%) 
Infections and infestations     
Abscess jaw  1  0/1487 (0.00%)  1/742 (0.13%) 
Abdominal sepsis  1  1/1487 (0.07%)  0/742 (0.00%) 
Appendicitis  1  1/1487 (0.07%)  0/742 (0.00%) 
Bronchitis  1  1/1487 (0.07%)  1/742 (0.13%) 
Campylobacter gastroenteritis  1  1/1487 (0.07%)  0/742 (0.00%) 
Clostridium difficile infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Cellulitis  1  2/1487 (0.13%)  0/742 (0.00%) 
Erysipelas  1  3/1487 (0.20%)  0/742 (0.00%) 
Diverticulitis  1  4/1487 (0.27%)  0/742 (0.00%) 
Gastroenteritis  1  1/1487 (0.07%)  0/742 (0.00%) 
Helicobacter infection  1  0/1487 (0.00%)  1/742 (0.13%) 
Implant site infection  1  0/1487 (0.00%)  1/742 (0.13%) 
Infected bite  1  1/1487 (0.07%)  0/742 (0.00%) 
Infective aneurysm  1  1/1487 (0.07%)  0/742 (0.00%) 
Influenza  1  2/1487 (0.13%)  0/742 (0.00%) 
Localised infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Medical device site joint infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Pneumonia  1  6/1487 (0.40%)  1/742 (0.13%) 
Peritonitis  1  0/1487 (0.00%)  1/742 (0.13%) 
Pulmonary sepsis  1  1/1487 (0.07%)  0/742 (0.00%) 
Pyelonephritis  1  2/1487 (0.13%)  0/742 (0.00%) 
Respiratory tract infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Salmonella bacteraemia  1  1/1487 (0.07%)  0/742 (0.00%) 
Sepsis  1  1/1487 (0.07%)  1/742 (0.13%) 
Skin infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Septic shock  1  1/1487 (0.07%)  1/742 (0.13%) 
Staphylococcal osteomyelitis  1  1/1487 (0.07%)  0/742 (0.00%) 
Tonsillitis bacterial  1  1/1487 (0.07%)  0/742 (0.00%) 
Urinary tract infection  1  2/1487 (0.13%)  1/742 (0.13%) 
Viral infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Wound infection  1  1/1487 (0.07%)  0/742 (0.00%) 
Gastroenteritis viral  1  0/1487 (0.00%)  1/742 (0.13%) 
Enteritis necroticans  1  0/1487 (0.00%)  1/742 (0.13%) 
Infective exacerbation of chronic obstructive airways disease  1  0/1487 (0.00%)  1/742 (0.13%) 
Injury, poisoning and procedural complications     
Anaemia postoperative  1  1/1487 (0.07%)  1/742 (0.13%) 
Alcohol poisoning  1  0/1487 (0.00%)  1/742 (0.13%) 
Cardiac function disturbance postoperative  1  0/1487 (0.00%)  1/742 (0.13%) 
Arterial injury  1  1/1487 (0.07%)  0/742 (0.00%) 
Facial bones fracture  1  2/1487 (0.13%)  0/742 (0.00%) 
Fall  1  1/1487 (0.07%)  0/742 (0.00%) 
Femur fracture  1  1/1487 (0.07%)  0/742 (0.00%) 
Foreign body  1  1/1487 (0.07%)  0/742 (0.00%) 
Head injury  1  0/1487 (0.00%)  1/742 (0.13%) 
Hip fracture  1  0/1487 (0.00%)  1/742 (0.13%) 
Humerus fracture  1  1/1487 (0.07%)  1/742 (0.13%) 
Incisional hernia  1  1/1487 (0.07%)  0/742 (0.00%) 
Multiple injuries  1  1/1487 (0.07%)  0/742 (0.00%) 
Radius fracture  1  2/1487 (0.13%)  0/742 (0.00%) 
Post procedural haemorrhage  1  1/1487 (0.07%)  1/742 (0.13%) 
Road traffic accident  1  0/1487 (0.00%)  1/742 (0.13%) 
Scapula fracture  1  1/1487 (0.07%)  0/742 (0.00%) 
Subarachnoid haemorrhage  1  1/1487 (0.07%)  0/742 (0.00%) 
Subdural haemorrhage  1  1/1487 (0.07%)  0/742 (0.00%) 
Thoracic vertebral fracture  1  1/1487 (0.07%)  0/742 (0.00%) 
Vascular graft thrombosis  1  1/1487 (0.07%)  0/742 (0.00%) 
Tendon rupture  1  1/1487 (0.07%)  0/742 (0.00%) 
Investigations     
Blood pressure increased  1  1/1487 (0.07%)  0/742 (0.00%) 
Liver function test abnormal  1  1/1487 (0.07%)  0/742 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/1487 (0.00%)  1/742 (0.13%) 
Diabetes mellitus inadequate control  1  0/1487 (0.00%)  1/742 (0.13%) 
Gout  1  1/1487 (0.07%)  0/742 (0.00%) 
Hypercalcaemia  1  0/1487 (0.00%)  1/742 (0.13%) 
Hyperkalaemia  1  2/1487 (0.13%)  0/742 (0.00%) 
Hyponatraemia  1  0/1487 (0.00%)  1/742 (0.13%) 
Type 2 diabetes mellitus  1  1/1487 (0.07%)  0/742 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/1487 (0.07%)  1/742 (0.13%) 
Arthritis  1  1/1487 (0.07%)  0/742 (0.00%) 
Foot deformity  1  1/1487 (0.07%)  0/742 (0.00%) 
Back pain  1  1/1487 (0.07%)  0/742 (0.00%) 
Intervertebral disc compression  1  1/1487 (0.07%)  0/742 (0.00%) 
Intervertebral disc protrusion  1  2/1487 (0.13%)  1/742 (0.13%) 
Intervertebral disc degeneration  1  1/1487 (0.07%)  0/742 (0.00%) 
Musculoskeletal pain  1  1/1487 (0.07%)  0/742 (0.00%) 
Lumbar spinal stenosis  1  1/1487 (0.07%)  0/742 (0.00%) 
Osteoarthritis  1  0/1487 (0.00%)  3/742 (0.40%) 
Myositis  1  1/1487 (0.07%)  0/742 (0.00%) 
Pain in extremity  1  1/1487 (0.07%)  0/742 (0.00%) 
Rotator cuff syndrome  1  1/1487 (0.07%)  0/742 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  2/1487 (0.13%)  0/742 (0.00%) 
Bladder cancer  1  1/1487 (0.07%)  1/742 (0.13%) 
Basal cell carcinoma  1  0/1487 (0.00%)  1/742 (0.13%) 
Brain neoplasm  1  1/1487 (0.07%)  0/742 (0.00%) 
Bladder neoplasm  1  2/1487 (0.13%)  0/742 (0.00%) 
Gallbladder cancer  1  1/1487 (0.07%)  0/742 (0.00%) 
Lung adenocarcinoma  1  1/1487 (0.07%)  0/742 (0.00%) 
Lung neoplasm malignant  1  3/1487 (0.20%)  0/742 (0.00%) 
Lung squamous cell carcinoma metastatic  1  1/1487 (0.07%)  0/742 (0.00%) 
Malignant melanoma  1  1/1487 (0.07%)  0/742 (0.00%) 
Oropharyngeal cancer  1  1/1487 (0.07%)  0/742 (0.00%) 
Metastases to liver  1  1/1487 (0.07%)  0/742 (0.00%) 
Pancreatic carcinoma  1  0/1487 (0.00%)  1/742 (0.13%) 
Prostate cancer  1  3/1487 (0.20%)  2/742 (0.27%) 
Ureteric cancer  1  0/1487 (0.00%)  1/742 (0.13%) 
Squamous cell carcinoma of skin  1  0/1487 (0.00%)  1/742 (0.13%) 
Nervous system disorders     
Brain oedema  1  2/1487 (0.13%)  0/742 (0.00%) 
Altered state of consciousness  1  1/1487 (0.07%)  0/742 (0.00%) 
Carotid artery disease  1  2/1487 (0.13%)  0/742 (0.00%) 
Carotid artery stenosis  1  1/1487 (0.07%)  1/742 (0.13%) 
Carotid artery occlusion  1  0/1487 (0.00%)  1/742 (0.13%) 
Cerebrovascular accident  1  3/1487 (0.20%)  2/742 (0.27%) 
Cerebral infarction  1  1/1487 (0.07%)  0/742 (0.00%) 
Dementia  1  1/1487 (0.07%)  0/742 (0.00%) 
Cognitive disorder  1  1/1487 (0.07%)  0/742 (0.00%) 
Dizziness  1  1/1487 (0.07%)  0/742 (0.00%) 
Headache  1  1/1487 (0.07%)  0/742 (0.00%) 
Ischaemic stroke  1  1/1487 (0.07%)  0/742 (0.00%) 
Ischaemic cerebral infarction  1  1/1487 (0.07%)  0/742 (0.00%) 
Neuralgia  1  1/1487 (0.07%)  0/742 (0.00%) 
Lumbar radiculopathy  1  1/1487 (0.07%)  0/742 (0.00%) 
Paraesthesia  1  0/1487 (0.00%)  1/742 (0.13%) 
Presyncope  1  1/1487 (0.07%)  1/742 (0.13%) 
Reversible ischaemic neurological deficit  1  0/1487 (0.00%)  1/742 (0.13%) 
Ruptured cerebral aneurysm  1  1/1487 (0.07%)  0/742 (0.00%) 
Speech disorder  1  1/1487 (0.07%)  0/742 (0.00%) 
Syncope  1  3/1487 (0.20%)  3/742 (0.40%) 
Transient ischaemic attack  1  3/1487 (0.20%)  2/742 (0.27%) 
Psychiatric disorders     
Major depression  1  0/1487 (0.00%)  1/742 (0.13%) 
Intensive care unit delirium  1  1/1487 (0.07%)  0/742 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/1487 (0.07%)  2/742 (0.27%) 
Haematuria  1  2/1487 (0.13%)  1/742 (0.13%) 
Nephrolithiasis  1  1/1487 (0.07%)  1/742 (0.13%) 
Renal colic  1  1/1487 (0.07%)  0/742 (0.00%) 
Urinary bladder polyp  1  1/1487 (0.07%)  0/742 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  3/1487 (0.20%)  1/742 (0.13%) 
Endometrial hyperplasia  1  1/1487 (0.07%)  0/742 (0.00%) 
Prostatitis  1  1/1487 (0.07%)  0/742 (0.00%) 
Uterine polyp  1  1/1487 (0.07%)  0/742 (0.00%) 
Uterine prolapse  1  2/1487 (0.13%)  0/742 (0.00%) 
Vaginal prolapse  1  1/1487 (0.07%)  0/742 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/1487 (0.07%)  0/742 (0.00%) 
Asthma  1  1/1487 (0.07%)  0/742 (0.00%) 
Acute respiratory failure  1  1/1487 (0.07%)  0/742 (0.00%) 
Chronic obstructive pulmonary disease  1  3/1487 (0.20%)  2/742 (0.27%) 
Dyspnoea  1  2/1487 (0.13%)  0/742 (0.00%) 
Eosinophilic pneumonia  1  1/1487 (0.07%)  0/742 (0.00%) 
Lung cyst  1  1/1487 (0.07%)  0/742 (0.00%) 
Pleural effusion  1  1/1487 (0.07%)  0/742 (0.00%) 
Pulmonary embolism  1  2/1487 (0.13%)  1/742 (0.13%) 
Sleep apnoea syndrome  1  2/1487 (0.13%)  0/742 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  1/1487 (0.07%)  1/742 (0.13%) 
Aortic stenosis  1  2/1487 (0.13%)  1/742 (0.13%) 
Blood pressure inadequately controlled  1  0/1487 (0.00%)  1/742 (0.13%) 
Haematoma  1  0/1487 (0.00%)  1/742 (0.13%) 
Deep vein thrombosis  1  2/1487 (0.13%)  0/742 (0.00%) 
Hypertension  1  1/1487 (0.07%)  0/742 (0.00%) 
Hypertensive crisis  1  1/1487 (0.07%)  1/742 (0.13%) 
Hypotension  1  0/1487 (0.00%)  1/742 (0.13%) 
Orthostatic hypotension  1  0/1487 (0.00%)  1/742 (0.13%) 
Intermittent claudication  1  0/1487 (0.00%)  1/742 (0.13%) 
Peripheral arterial occlusive disease  1  2/1487 (0.13%)  3/742 (0.40%) 
Peripheral artery aneurysm  1  1/1487 (0.07%)  0/742 (0.00%) 
Peripheral artery occlusion  1  0/1487 (0.00%)  1/742 (0.13%) 
Peripheral artery thrombosis  1  0/1487 (0.00%)  1/742 (0.13%) 
Peripheral vascular disorder  1  1/1487 (0.07%)  0/742 (0.00%) 
Peripheral ischaemia  1  1/1487 (0.07%)  0/742 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Bempedoic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   792/1487 (53.26%)   381/742 (51.35%) 
Blood and lymphatic system disorders     
Anaemia  1  41/1487 (2.76%)  15/742 (2.02%) 
Cardiac disorders     
Angina pectoris  1  24/1487 (1.61%)  19/742 (2.56%) 
Gastrointestinal disorders     
Nausea  1  43/1487 (2.89%)  19/742 (2.56%) 
Constipation  1  26/1487 (1.75%)  18/742 (2.43%) 
Diarrhoea  1  60/1487 (4.03%)  30/742 (4.04%) 
General disorders     
Fatigue  1  38/1487 (2.56%)  25/742 (3.37%) 
Infections and infestations     
Bronchitis  1  52/1487 (3.50%)  19/742 (2.56%) 
Lower respiratory tract infection  1  41/1487 (2.76%)  19/742 (2.56%) 
Sinusitis  1  26/1487 (1.75%)  18/742 (2.43%) 
Nasopharyngitis  1  146/1487 (9.82%)  87/742 (11.73%) 
Urinary tract infection  1  70/1487 (4.71%)  47/742 (6.33%) 
Upper respiratory tract infection  1  72/1487 (4.84%)  31/742 (4.18%) 
Investigations     
Blood creatine phosphokinase increased  1  35/1487 (2.35%)  13/742 (1.75%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  32/1487 (2.15%)  22/742 (2.96%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  64/1487 (4.30%)  44/742 (5.93%) 
Back pain  1  55/1487 (3.70%)  18/742 (2.43%) 
Muscle spasms  1  62/1487 (4.17%)  20/742 (2.70%) 
Osteoarthritis  1  30/1487 (2.02%)  23/742 (3.10%) 
Myalgia  1  89/1487 (5.99%)  45/742 (6.06%) 
Musculoskeletal pain  1  40/1487 (2.69%)  19/742 (2.56%) 
Pain in extremity  1  50/1487 (3.36%)  16/742 (2.16%) 
Nervous system disorders     
Dizziness  1  65/1487 (4.37%)  31/742 (4.18%) 
Headache  1  45/1487 (3.03%)  24/742 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  47/1487 (3.16%)  23/742 (3.10%) 
Dyspnoea  1  19/1487 (1.28%)  16/742 (2.16%) 
Vascular disorders     
Hypertension  1  42/1487 (2.82%)  26/742 (3.50%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Esperion Therapeutics, Inc.
Phone: 1-833-377-7633
EMail: medinfo@esperion.com
Other Publications:
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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Erratum in: Circulation. 2015 Dec 22;132(25):e396.
Layout table for additonal information
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT02666664    
Other Study ID Numbers: 1002-040
2015-004136-36 ( EudraCT Number )
First Submitted: January 20, 2016
First Posted: January 28, 2016
Results First Submitted: March 20, 2020
Results First Posted: April 20, 2020
Last Update Posted: May 11, 2020