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CompletedNCT03337308Updated Apr 8, 2020Results posted

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

A Phase 3 interventional study of Bempedoic Acid + Ezetimibe Fixed-Dose Combination and Bempedoic Acid in Hyperlipidemias, sponsored by Esperion Therapeutics, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-08.

Sponsored by Esperion Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
382
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.

02

Conditions studied

  • Hyperlipidemias

Keywords

  • hyperlipidemia
  • heterozygous familial hypercholesterolemia
  • atherosclerotic cardiovascular disease
  • high cholesterol
  • ASCVD
  • HeFH
  • LDL
03

In context

Hyperlipidemias

861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.

This study's enrollment of 382 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Esperion Therapeutics, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Browse Esperion Therapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
  • Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
  • Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Exclusion criteria

Exclusion Criteria:

  • Total Fasting Triglyceride ≥ 400 mg/dL
  • Renal Dysfunction or nephrotic syndrome or history of nephritis
  • Significant cardiovascular disease or cardiovascular event within the past 3 months
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
382 participants (actual)

Study arms

  • Experimental
    BA 180 mg + EZE 10 mg FDC

    Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks

    Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination · Drug: Placebos

  • Experimental
    BA 180 mg

    Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks

    Drug: Bempedoic Acid · Drug: Placebos

  • Active comparator
    EZE 10 mg

    Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks

    Drug: Ezetimibe · Drug: Placebos

  • Placebo comparator
    Placebos

    Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks

    Drug: Placebos

Interventions

  • Combination productBempedoic Acid + Ezetimibe Fixed-Dose Combination

    Drug pages: Bempedoic acid · Ezetimibe

    bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet

    Also known as: Bempedoic Acid + Zetia FDC, ETC-1002 + Zetia

  • DrugBempedoic Acid

    bempedoic acid 180 mg tablet

    Also known as: ETC-1002

  • DrugEzetimibe

    ezetimibe 10 mg overencapsulated tablet

    Also known as: Zetia

  • DrugPlacebos

    placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. 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 LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.

    Time frame: Baseline; Week 12

Secondary outcomes

  1. 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 predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: (\[hsCRP value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

    Time frame: Baseline; Week 12

  2. 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 non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: (\[non-HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

    Time frame: Baseline; Week 12

  3. 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 TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: (\[TC value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

    Time frame: Baseline; Week 12

  4. Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)

    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: (\[apo B value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

    Time frame: Baseline; Week 12

  5. Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (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 HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\[HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

    Time frame: Baseline; Week 12

  6. Percent Change From Baseline to Week 12 in Triglycerides (TGs)

    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\[TGs value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

    Time frame: Baseline; Week 12

07

Results

Posted Apr 8, 2020
Limitations and caveats
After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.

Participant flow

Participant flow — Overall Study
MilestoneBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Started10811010955
Completed10310310453
Not completed5752
Withdrew: Adverse event2331
Withdrew: Lost to follow-up1200
Withdrew: Withdrawal by subject2121
Withdrew: Protocol violation0100

Outcome measures

PrimaryPercent 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 LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
Percent ChangeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)-36.2 ± 2.56-17.2 ± 2.52-23.2 ± 2.181.8 ± 3.49
Statistical analysis
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo · ANCOVA · p = <0.001 · Difference of least squares (ls) means: -38.0 · 95% CI -46.5 to -29.6Standard Error of the Difference of Least Squares (LS) Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Bempedoic Acid 180 mg · ANCOVA · p = <0.001 · Difference of ls means: -19.0 · 95% CI -26.1 to -11.9Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Ezetimibe 10 mg · ANCOVA · p = <0.001 · Difference of ls means: -13.1 · 95% CI -19.7 to -6.5Standard Error of the Difference of LS Means
SecondaryPercent 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 predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: (\[hsCRP value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

Time frame:
Baseline; Week 12
Reported as:
Median · Percent Change
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
Percent ChangeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)-35.1 (-56.5 to -2.3)-31.9 (-62.6 to 7.7)-8.2 (-34.4 to 32.0)21.6 (-18.5 to 68.5)
Statistical analysis
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo · Wilcoxon rank sum test · p = <0.001 (using alpha = 0.01) · Location shift: -46.1 · 99% CI -78.75 to -15.78Standard Error of the Hodges-Lehmann Median Difference
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Ezetimibe 10 mg · Wilcoxon rank sum test · p = 0.002 (using alpha = 0.02) · Median difference (final values): -25.6 · 98% CI -45.00 to -7.15Standard Error of the Hodges-Lehmann Median Difference
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Bempedoic Acid 180 mg · Wilcoxon rank sum test · p = 0.734 (using alpha = 0.02) · Median difference (final values): -2.6 · 98% CI -21.35 to 16.25Standard Error of the Hodges-Lehmann Median Difference
SecondaryPercent 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 non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: (\[non-HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Percent changeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)-31.9 ± 2.23-14.1 ± 2.17-19.9 ± 2.051.8 ± 3.28
Statistical analysis
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo · ANCOVA · p = <0.001 · Difference in ls mean: -33.7 · 99% CI -43.9 to -23.4Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Bempedoic Acid 180 mg · ANCOVA · p = <0.001 (using alpha = 0.02) · Difference in ls means: -17.8 · 98% CI -25.1 to -10.5Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Ezetimibe 10 mg · ANCOVA · p = <0.001 (using alpha = 0.02) · Difference in ls means: -12.1 · 98% CI -19.1 to -5.0Standard Error of the Difference of LS Means
SecondaryPercent 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 TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: (\[TC value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
Percent changeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)-26.4 ± 1.90-12.1 ± 1.83-16.0 ± 1.590.7 ± 2.46
Statistical analysis
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo · ANCOVA · p = <0.001 (using alpha = 0.01) · Difference of ls means: -27.1 · 99% CI -35.1 to -19.1Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Bempedoic Acid 180 mg · ANCOVA · p = <0.001 (using alpha = 0.02) · Difference of ls means: -14.2 · 98% CI -20.4 to -8.1Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Ezetimibe 10 mg · ANCOVA · p = <0.001 (using alpha = 0.02) · Difference of ls means: -10.4 · 98% CI -16.1 to -4.6Standard Error of the Difference of LS Means
SecondaryPercent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: (\[apo B value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

Time frame:
Baseline; Week 12
Reported as:
Least squares mean · Percent change
Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)
Percent changeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)-24.6 ± 2.38-11.8 ± 2.18-15.3 ± 1.975.5 ± 2.97
Statistical analysis
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Placebo · ANCOVA · p = <0.001 (using alpha = 0.01) · Difference of ls means: -30.1 · 99% CI -39.9 to -20.3Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Bempedoic Acid 180 mg · ANCOVA · p = <0.001 (using alpha = 0.02) · Difference of ls means: -12.8 · 98% CI -20.3 to -5.3Standard Error of the Difference of LS Means
  • Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC vs Ezetimibe 10 mg · ANCOVA · p = 0.003 (using alpha = 0.02) · Difference of ls means: -9.3 · 98% CI -16.5 to -2.1Standard Error of the Difference of LS Means
SecondaryPercent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (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 HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\[HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

Time frame:
Baseline; Week 12
Reported as:
Mean · Percent change
Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
Percent changeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)-5.59 ± 12.269-5.40 ± 14.688-2.11 ± 11.590-0.54 ± 12.799
SecondaryPercent Change From Baseline to Week 12 in Triglycerides (TGs)

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: (\[TGs value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100.

Time frame:
Baseline; Week 12
Reported as:
Mean · Percent change
Percent Change From Baseline to Week 12 in Triglycerides (TGs)
Percent changeBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Percent Change From Baseline to Week 12 in Triglycerides (TGs)-7.90 ± 25.6337.94 ± 42.312-2.46 ± 33.4025.47 ± 31.992

Adverse events

Collected over Up to approximately 14 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC0/107 (0%)8/107 (7.5%)26/107 (24.3%)
Bempedoic Acid 180 mg0/110 (0%)7/110 (6.4%)27/110 (24.5%)
Ezetimibe 10 mg0/109 (0%)10/109 (9.2%)26/109 (23.9%)
Placebo0/55 (0%)1/55 (1.8%)12/55 (21.8%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Acute myocardial infarctionCardiac disorders1/1072/1103/1090/55
Coronary artery diseaseCardiac disorders1/1070/1100/1091/55
Myocardial infarctionCardiac disorders0/1071/1100/1091/55
Angina pectorisCardiac disorders1/1070/1100/1090/55
Atrial fibrillationCardiac disorders1/1070/1100/1090/55
Myocardial ischaemiaCardiac disorders1/1070/1100/1090/55
Non-cardiac chest painGeneral disorders1/1070/1100/1090/55
Rhinovirus infectionInfections and infestations1/1070/1100/1090/55
HemiparesisNervous system disorders1/1070/1100/1090/55
Cardiac failure congestiveCardiac disorders0/1070/1101/1090/55
Most frequent other events
Showing 10 of 11
Most frequent other events
EventBempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlacebo
Urinary tract infectionInfections and infestations8/1073/1103/1092/55
NasopharyngitisInfections and infestations4/1076/1104/1091/55
MyalgiaMusculoskeletal and connective tissue disorders2/1075/1102/1091/55
HypertensionVascular disorders3/1075/1102/1090/55
ConstipationGastrointestinal disorders4/1070/1102/1090/55
ArthralgiaMusculoskeletal and connective tissue disorders1/1074/1104/1092/55
Back painMusculoskeletal and connective tissue disorders3/1073/1104/1092/55
Muscle spasmsMusculoskeletal and connective tissue disorders2/1071/1104/1090/55
AnaemiaBlood and lymphatic system disorders1/1072/1101/1092/55
HeadacheNervous system disorders2/1074/1102/1091/55

Baseline characteristics

Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.

Age, Continuous
Age, Continuous(Years)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Mean63.0 ± 9.9765.2 ± 9.5464.4 ± 8.9165.6 ± 10.7464.4 ± 9.68
Sex: Female, Male
Sex: Female, Male(Participants)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Female58655722202
Male50455233180
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Hispanic or Latino32333220117
Not Hispanic or Latino76777735265
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
American Indian or Alaska Native10001
Asian21104
Native Hawaiian or Other Pacific Islander00101
Black or African American201916762
White85909148314
More than one race00000
Unknown or Not Reported00000
Low-density lipoprotein cholesterol (LDL-C)
Low-density lipoprotein cholesterol (LDL-C)(milligrams per deciliter (mg/dL))Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Mean153.80 ± 40.526145.13 ± 38.456148.80 ± 41.839152.80 ± 46.773149.70 ± 41.162
Non-high-density lipoprotein cholesterol (non-HDL-C)
Non-high-density lipoprotein cholesterol (non-HDL-C)(mg/dL)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Mean188.22 ± 46.657175.67 ± 40.474180.18 ± 47.308180.91 ± 49.720181.26 ± 45.595
Total cholesterol (TC)
Total cholesterol (TC)(mg/dL)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Mean237.32 ± 48.694225.55 ± 43.165231.41 ± 50.478231.27 ± 50.210231.36 ± 47.857
Apolipoprotein B (apo B)
Apolipoprotein B (apo B)(mg/dL)Bempedoic Acid 180 mg + Ezetimibe 10 mg FDCBempedoic Acid 180 mgEzetimibe 10 mgPlaceboTotal
Mean121.1 ± 30.85113.4 ± 26.43115.5 ± 31.30115.1 ± 32.52116.4 ± 29.98

3 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • PMG Research of McFarland
    Ames, Iowa 50010, United States
  • Foundation Cardiology
    Nashua, New Hampshire 03060, United States
  • PMG Research of Piedmont Healthcare
    Statesville, North Carolina 28625, United States
  • PMG Research of Wilmington
    Wilmington, North Carolina 28401, United States
  • PMG Research of Knoxville
    Knoxville, Tennessee 37912, United States
09

References and documents

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. PubMed 27892461 ↗
  • Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8. PubMed 21067804 ↗
  • Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available. PubMed 27594540 ↗
  • Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985. PubMed 27673306 ↗
  • 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. doi: 10.1161/CIR.0000000000000346. PubMed 24222016 ↗
  • Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29. PubMed 31357887 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03337308
Lead sponsor
Esperion Therapeutics, Inc.
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Oct 23, 2017
Primary completion
Jun 18, 2018
Completion
Jul 18, 2018
Results posted
Apr 8, 2020
Last update
Apr 8, 2020

Study contacts

Ron Haberman, MD
study director · Esperion Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bempedoic acid · Ezetimibe

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