Hyperlipidemias
Conditions
Keywords
hyperlipidemia, heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease, high cholesterol, ASCVD, HeFH, LDL
Brief 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.
Interventions
COMBINATION_PRODUCTBempedoic Acid + Ezetimibe Fixed-Dose Combination
bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
DRUGBempedoic Acid
bempedoic acid 180 mg tablet
DRUGEzetimibe
ezetimibe 10 mg overencapsulated tablet
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
Sponsors
Esperion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline; Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Baseline; Week 12 | 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. |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Baseline; Week 12 | 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. |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Baseline; Week 12 | 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. |
| Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Baseline; Week 12 | 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. |
| Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Baseline; Week 12 | 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. |
| Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | Baseline; Week 12 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.
Participants by arm
| Arm | Count |
|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | 108 |
| Bempedoic Acid 180 mg Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks. | 110 |
| Ezetimibe 10 mg Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | 109 |
| Placebo Participants received placebo to match the bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. | 55 |
| Total | 382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Bempedoic Acid 180 mg | Ezetimibe 10 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.0 Years STANDARD_DEVIATION 9.97 | 65.2 Years STANDARD_DEVIATION 9.54 | 64.4 Years STANDARD_DEVIATION 8.91 | 65.6 Years STANDARD_DEVIATION 10.74 | 64.4 Years STANDARD_DEVIATION 9.68 |
| Apolipoprotein B (apo B) | 121.1 mg/dL STANDARD_DEVIATION 30.85 | 113.4 mg/dL STANDARD_DEVIATION 26.43 | 115.5 mg/dL STANDARD_DEVIATION 31.3 | 115.1 mg/dL STANDARD_DEVIATION 32.52 | 116.4 mg/dL STANDARD_DEVIATION 29.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 33 Participants | 32 Participants | 20 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 77 Participants | 77 Participants | 35 Participants | 265 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| High-density lipoprotein cholesterol (HDL-C) | 49.19 mg/dL STANDARD_DEVIATION 14.566 | 49.89 mg/dL STANDARD_DEVIATION 12.383 | 51.23 mg/dL STANDARD_DEVIATION 15.902 | 50.40 mg/dL STANDARD_DEVIATION 14.067 | 50.14 mg/dL STANDARD_DEVIATION 14.256 |
| High-sensitivity C-reactive protein (hsCRP) | 3.08 milligrams per liter (mg/L) | 2.91 milligrams per liter (mg/L) | 2.78 milligrams per liter (mg/L) | 3.01 milligrams per liter (mg/L) | 2.96 milligrams per liter (mg/L) |
| Low-density lipoprotein cholesterol (LDL-C) | 153.80 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 40.526 | 145.13 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 38.456 | 148.80 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 41.839 | 152.80 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 46.773 | 149.70 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 41.162 |
| Non-high-density lipoprotein cholesterol (non-HDL-C) | 188.22 mg/dL STANDARD_DEVIATION 46.657 | 175.67 mg/dL STANDARD_DEVIATION 40.474 | 180.18 mg/dL STANDARD_DEVIATION 47.308 | 180.91 mg/dL STANDARD_DEVIATION 49.72 | 181.26 mg/dL STANDARD_DEVIATION 45.595 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 19 Participants | 16 Participants | 7 Participants | 62 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 85 Participants | 90 Participants | 91 Participants | 48 Participants | 314 Participants |
| Sex: Female, Male Female | 58 Participants | 65 Participants | 57 Participants | 22 Participants | 202 Participants |
| Sex: Female, Male Male | 50 Participants | 45 Participants | 52 Participants | 33 Participants | 180 Participants |
| Total cholesterol (TC) | 237.32 mg/dL STANDARD_DEVIATION 48.694 | 225.55 mg/dL STANDARD_DEVIATION 43.165 | 231.41 mg/dL STANDARD_DEVIATION 50.478 | 231.27 mg/dL STANDARD_DEVIATION 50.21 | 231.36 mg/dL STANDARD_DEVIATION 47.857 |
| Triglycerides (TGs) | 177.19 mg/dL STANDARD_DEVIATION 94.904 | 156.65 mg/dL STANDARD_DEVIATION 71.985 | 161.73 mg/dL STANDARD_DEVIATION 79.924 | 144.59 mg/dL STANDARD_DEVIATION 55.814 | 162.33 mg/dL STANDARD_DEVIATION 79.973 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 110 | 0 / 109 | 0 / 55 |
| other Total, other adverse events | 26 / 107 | 27 / 110 | 26 / 109 | 12 / 55 |
| serious Total, serious adverse events | 8 / 107 | 7 / 110 | 10 / 109 | 1 / 55 |
Outcome results
Primary
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
Population: Full Analysis Set (FAS), also known as the intention-to-treat set, was defined as all randomized participants. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | -36.2 Percent Change | Standard Error 2.56 |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | -17.2 Percent Change | Standard Error 2.52 |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | -23.2 Percent Change | Standard Error 2.18 |
| Placebo | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | 1.8 Percent Change | Standard Error 3.49 |
p-value: <0.00195% CI: [-46.5, -29.6]ANCOVA
p-value: <0.00195% CI: [-26.1, -11.9]ANCOVA
p-value: <0.00195% CI: [-19.7, -6.5]ANCOVA
Secondary
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
Population: FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | -24.6 Percent change | Standard Error 2.38 |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | -11.8 Percent change | Standard Error 2.18 |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | -15.3 Percent change | Standard Error 1.97 |
| Placebo | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | 5.5 Percent change | Standard Error 2.97 |
p-value: <0.00199% CI: [-39.9, -20.3]ANCOVA
p-value: <0.00198% CI: [-20.3, -5.3]ANCOVA
p-value: 0.00398% CI: [-16.5, -2.1]ANCOVA
Secondary
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
Population: FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | -5.59 Percent change | Standard Deviation 12.269 |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | -5.40 Percent change | Standard Deviation 14.688 |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | -2.11 Percent change | Standard Deviation 11.59 |
| Placebo | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | -0.54 Percent change | Standard Deviation 12.799 |
Secondary
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
Population: FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice;therefore, analysis was completed with all efficacy data from these sites removed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | -35.1 Percent Change |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | -31.9 Percent Change |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | -8.2 Percent Change |
| Placebo | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | 21.6 Percent Change |
p-value: <0.00199% CI: [-78.75, -15.78]Wilcoxon rank sum test
p-value: 0.00298% CI: [-45, -7.15]Wilcoxon rank sum test
p-value: 0.73498% CI: [-21.35, 16.25]Wilcoxon rank sum test
Secondary
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
Population: FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -31.9 Percent change | Standard Error 2.23 |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -14.1 Percent change | Standard Error 2.17 |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -19.9 Percent change | Standard Error 2.05 |
| Placebo | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 1.8 Percent change | Standard Error 3.28 |
p-value: <0.00199% CI: [-43.9, -23.4]ANCOVA
p-value: <0.00198% CI: [-25.1, -10.5]ANCOVA
p-value: <0.00198% CI: [-19.1, -5]ANCOVA
Secondary
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
Population: FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | -26.4 Percent change | Standard Error 1.9 |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | -12.1 Percent change | Standard Error 1.83 |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | -16.0 Percent change | Standard Error 1.59 |
| Placebo | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | 0.7 Percent change | Standard Error 2.46 |
p-value: <0.00199% CI: [-35.1, -19.1]ANCOVA
p-value: <0.00198% CI: [-20.4, -8.1]ANCOVA
p-value: <0.00198% CI: [-16.1, -4.6]ANCOVA
Secondary
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
Population: FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | -7.90 Percent change | Standard Deviation 25.633 |
| Bempedoic Acid 180 mg | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | 7.94 Percent change | Standard Deviation 42.312 |
| Ezetimibe 10 mg | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | -2.46 Percent change | Standard Deviation 33.402 |
| Placebo | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | 5.47 Percent change | Standard Deviation 31.992 |