Hypercholesterolemia
Conditions
Keywords
Cholesterol, PCSK9, Repatha, evolocumab, LDL-C
Brief summary
The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.
Interventions
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
OTHERplacebo
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
DRUGevolocumab
Monthly PCSK9i (evolocumab) background therapy
Sponsors
Esperion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years or legal age of majority depending on regional law * Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL * Men and nonpregnant, nonlactating women
Exclusion criteria
* Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia * Total fasting TG ≥500 mg/dL * Renal dysfunction or a glomerulonephropathy; eGFR \<30 mL/min/1.73 m2 * Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD) * History of type 1 or type 2 diabetes * Uncontrolled hypertension * Uncontrolled hypothyroidism * Liver disease or dysfunction * Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass) * History of hematologic or coagulation disorders * History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ) * Unexplained creatine kinase (CK) \>3 × ULN * Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib * Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2 | Baseline; Month 2 | Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in LDL-C at Month 1 and Month 2 | Baseline; Month 1 and Month 2 | Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the average of the Screening Visit 4 and the Day 1 value. If only 1 value is available, then that single value is used as Baseline. Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF. |
| Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | Baseline; Month 1 and Month 2 | Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline apolipoprotein B (apoB) is defined as the Day 1 value. Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values. If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF. |
| Percent Change From Baseline in LDL-C at Month 1 | Baseline; Month 1 | Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis. |
| Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | up to Month 2 (until 30 days after last dose) | Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product. |
| Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | Month 1 and Month 2 | The number of participants with ALT or AST \>3x ULN was measured. |
| Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2 | Baseline; Month 1 and Month 2 | Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the Day 1 value. Percent change from Baseline was analyzed using a non-parametric approach. Missing Month 2 data were handled by LOCF. Observed data were used for analysis at Month 1. |
Countries
United States
Participant flow
Recruitment details
170 participants were screened; out of 170, 59 participants were randomized. One participant never received study medication and withdrew from the study due to the Sponsor's decision.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Plus Evolocumab Participants received a matching oral placebo tablet taken once a day, plus evolocumab 420 milligrams (mg) injected over 9 minutes once a month as background therapy. | 30 |
| Bempedoic Acid Plus Evolocumab Participants received a bempedoic acid 180 mg tablet orally once a day (with or without food), plus evolocumab 420 mg injected over 9 minutes once a month as background therapy. | 28 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant Left State | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Bempedoic Acid Plus Evolocumab | Total | Placebo Plus Evolocumab |
|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 9.36 | 60.1 years STANDARD_DEVIATION 10.4 | 58.4 years STANDARD_DEVIATION 11.16 |
| Baseline Apolipoprotein B (apoB) Values | 87.5 mg/dL STANDARD_DEVIATION 27.13 | 87.7 mg/dL STANDARD_DEVIATION 25.29 | 87.9 mg/dL STANDARD_DEVIATION 23.8 |
| Baseline High-Sensitivity C-Reactive Protein (hs-CRP) Values | 3.125 milligrams per Liter | 2.340 milligrams per Liter | 2.090 milligrams per Liter |
| Baseline Low-Density Lipoprotein Cholesterol (L-DLC) Values | 102.09 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 28.982 | 103.14 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 30.395 | 104.12 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 32.121 |
| Baseline Total Cholesterol (TC) and Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Values non-HDL-C | 129.68 mg/dL STANDARD_DEVIATION 36.301 | 131.37 mg/dL STANDARD_DEVIATION 36.172 | 132.95 mg/dL STANDARD_DEVIATION 36.599 |
| Baseline Total Cholesterol (TC) and Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) Values TC | 186.20 mg/dL STANDARD_DEVIATION 38.343 | 188.34 mg/dL STANDARD_DEVIATION 38.601 | 190.33 mg/dL STANDARD_DEVIATION 39.387 |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 52 Participants | 28 Participants |
| Sex: Female, Male Female | 21 Participants | 36 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 22 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 7 / 30 | 8 / 28 |
| serious Total, serious adverse events | 0 / 30 | 1 / 28 |
Outcome results
Primary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
Time frame: Baseline; Month 2
Population: Modified Intent-to-Treat (mITT) Population: all randomized participants with a Baseline lipid value and at least 1 post-Baseline lipid value who received investigational medicinal product (IMP) within 2 days before the lipid measurement and evolocumab 420 mg within 30 days plus or minus 3 days before the lipid measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Evolocumab | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2 | 2.783 percent change | Standard Error 3.412 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2 | -27.478 percent change | Standard Error 4.31 |
p-value: <0.00195% CI: [-41.324, -19.199]ANCOVA
Secondary
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the average of the Screening Visit 4 and the Day 1 value. If only 1 value is available, then that single value is used as Baseline. Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Time frame: Baseline; Month 1 and Month 2
Population: Modified Intent-to-Treat Population. Only those participants with data available were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Evolocumab | Absolute Change From Baseline in LDL-C at Month 1 and Month 2 | Month 1 | 1.75 milligrams per deciliter (mg/dL) | Standard Error 3.118 |
| Placebo Plus Evolocumab | Absolute Change From Baseline in LDL-C at Month 1 and Month 2 | Month 2 | -0.02 milligrams per deciliter (mg/dL) | Standard Error 3.386 |
| Bempedoic Acid Plus Evolocumab | Absolute Change From Baseline in LDL-C at Month 1 and Month 2 | Month 1 | -36.51 milligrams per deciliter (mg/dL) | Standard Error 46.41 |
| Bempedoic Acid Plus Evolocumab | Absolute Change From Baseline in LDL-C at Month 1 and Month 2 | Month 2 | -29.92 milligrams per deciliter (mg/dL) | Standard Error 4.461 |
Comparison: Month 1p-value: <0.00195% CI: [-49.558, -26.944]ANCOVA
Comparison: Month 2p-value: <0.00195% CI: [-41.176, -18.626]ANCOVA
Secondary
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
The number of participants with ALT or AST \>3x ULN was measured.
Time frame: Month 1 and Month 2
Population: Safety Population. Only those participants with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | ALT, Month 1 | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | ALT, Month 2 | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | AST, Month 1 | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | AST, Month 2 | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | AST, Month 2 | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | ALT, Month 1 | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | AST, Month 1 | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 | ALT, Month 2 | 0 Participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product.
Time frame: up to Month 2 (until 30 days after last dose)
Population: Safety Population: all randomized participants who received at least 1 dose of IMP. Participants in the Safety Population were included in the treatment group that they received, regardless of their randomized treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TEAEs related to IMP | 1 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TESAEs related to IMP | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Deaths | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Any TEAE | 7 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TEAEs related to evolocumab | 1 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TESAEs | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TESAEs related to evolocumab | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Discontinuation of IMP due to TEAE | 0 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Mild TEAEs | 5 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Moderate TEAEs | 2 Participants |
| Placebo Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Severe TEAEs | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Mild TEAEs | 4 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TEAEs related to IMP | 1 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TESAEs related to evolocumab | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TESAEs related to IMP | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Deaths | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Severe TEAEs | 1 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Any TEAE | 9 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Discontinuation of IMP due to TEAE | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TEAEs related to evolocumab | 0 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | Moderate TEAEs | 4 Participants |
| Bempedoic Acid Plus Evolocumab | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) | TESAEs | 1 Participants |
Secondary
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the Day 1 value. Percent change from Baseline was analyzed using a non-parametric approach. Missing Month 2 data were handled by LOCF. Observed data were used for analysis at Month 1.
Time frame: Baseline; Month 1 and Month 2
Population: Modified Intent-to-Treat Population. Only those participants with data available were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Plus Evolocumab | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2 | hs-CRP at Month 1 | 10.658 percent change |
| Placebo Plus Evolocumab | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2 | hs-CRP at Month 2 | -1.623 percent change |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2 | hs-CRP at Month 1 | -23.349 percent change |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2 | hs-CRP at Month 2 | -34.444 percent change |
Comparison: hs-CRP at Month 1p-value: 0.04695% CI: [-70.524, -2.339]Wilcoxon rank sum test
Comparison: hs-CRP at Month 2p-value: 0.02995% CI: [-51.455, -3.93]Wilcoxon rank sum test
Secondary
Percent Change From Baseline in LDL-C at Month 1
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis.
Time frame: Baseline; Month 1
Population: Modified Intent-to-Treat Population. Only those participants with data available were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus Evolocumab | Percent Change From Baseline in LDL-C at Month 1 | 3.172 percent change | Standard Error 2.7 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in LDL-C at Month 1 | -32.712 percent change | Standard Error 4.385 |
p-value: <0.00195% CI: [-46.303, -25.466]ANCOVA
Secondary
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline apolipoprotein B (apoB) is defined as the Day 1 value. Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values. If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Time frame: Baseline; Month 1 and Month 2
Population: mITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | TC at Month 1 | 1.170 percent change | Standard Error 1.877 |
| Placebo Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | apo-B at Month 1 | 0.547 percent change | Standard Error 2.948 |
| Placebo Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | non-HDL-C at Month 1 | 2.077 percent change | Standard Error 2.378 |
| Placebo Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | apo-B at Month 2 | 2.706 percent change | Standard Error 2.182 |
| Placebo Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | non-HDL-C at Month 2 | 1.285 percent change | Standard Error 2.783 |
| Placebo Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | TC at Month 2 | 0.557 percent change | Standard Error 2.009 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | non-HDL-C at Month 2 | -22.960 percent change | Standard Error 3.951 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | apo-B at Month 2 | -21.763 percent change | Standard Error 3.736 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | apo-B at Month 1 | -26.484 percent change | Standard Error 4.175 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | TC at Month 2 | -16.963 percent change | Standard Error 3.228 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | non-HDL-C at Month 1 | -29.563 percent change | Standard Error 4.031 |
| Bempedoic Acid Plus Evolocumab | Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 | TC at Month 1 | -20.770 percent change | Standard Error 3.025 |
Comparison: Apo B at Month 1p-value: <0.00195% CI: [-37.509, -16.553]ANCOVA
Comparison: Apo B at Month 2p-value: <0.00195% CI: [-33.225, -15.713]ANCOVA
Comparison: non-HDL-C at Month 1p-value: <0.00195% CI: [-41.116, -22.163]ANCOVA
Comparison: non-HDL-C at Month 2p-value: <0.00195% CI: [-33.987, -14.505]ANCOVA
Comparison: TC at Month 1p-value: <0.00195% CI: [-29.153, -14.729]ANCOVA
Comparison: TC at Month 2p-value: <0.00195% CI: [-25.201, -9.839]ANCOVA