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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,230
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Cottonwood, Arizona, United States
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Phoenix, Arizona, United States
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Canoga Park, California, United States
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Santa Rosa, California, United States
Unnamed facility
Bridgeport, Connecticut, United States
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Hartford, Connecticut, United States
Unnamed facility
Atlantis, Florida, United States
Unnamed facility
Boca Raton, Florida, United States
Unnamed facility
Crestview, Florida, United States
...and 94 more locations
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 52
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.
Time frame: 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.
Time frame: Baseline; Week 12