Hypercholesterolemia
Conditions
Keywords
lipid-lowering drugs, statin intolerance
Brief summary
This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.
Interventions
DRUGETC-1002
Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day
DRUGPlacebo
Placebo once daily for 8 weeks
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 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment * For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides \<350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements) * For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG \<400 mg/dL Key
Exclusion criteria
* Acute significant cardiovascular disease * Poorly controlled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 8 in Apolipoprotein AI | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C) | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in Non-HDL-C | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in Total Cholesterol | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in Triglycerides | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in Apolipoprotein B | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Baseline; Weeks 2, 4, 6, and 8 | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. hsCRP results indicated as \<0.2 in the laboratory data were set to 0.2 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement. |
| Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA) | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. |
| Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Baseline; up to 8 weeks | Participants were analyzed to evaluate the LDL-C target of \<100 mg/dL for high risk participants with cardiovascular diseases. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). |
| Number or Participants With Treatment-emergent Adverse Events (TEAEs) | up to 8 weeks | TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. |
| Number of Participants With Muscle-Related TEAEs | up to 8 weeks | TEAEs were defined as AEs that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. |
| Percent Change From Baseline to Week 8 in Lipoprotein (a) | Baseline; 8 weeks | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data are based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. Lipoprotein (a) results indicated as \<3 in the laboratory data were set to 3 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ETC-1002 Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks. | 37 |
| Placebo Participants received placebo QD on Day 1 for 8 weeks. | 19 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 |
| Overall Study | Per Investigator/Sponsor/Regulatory Body | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | ETC-1002 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 5.42 | 60.4 years STANDARD_DEVIATION 7.88 | 62.8 years STANDARD_DEVIATION 6.51 |
| Calculated Low-density Lipoprotein Cholesterol (LDL-C) | 175.7 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 36.52 | 184.8 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 32.53 | 178.9 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 35.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 19 Participants | 54 Participants |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 20 Participants | 8 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 19 |
| other Total, other adverse events | 19 / 37 | 15 / 19 |
| serious Total, serious adverse events | 1 / 37 | 0 / 19 |
Outcome results
Primary
Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: Modified Intent-to-Treat (mITT) Population: All randomized participants who received at least 1 dose of study medication and had a Baseline assessment and at least 1 post-Baseline assessment, excluding any assessments taken more than 2 days after a dose of study medication. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | -32.0 Percent Change | Standard Error 1.93 |
| Placebo | Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | -3.3 Percent Change | Standard Error 2.69 |
p-value: <0.000195% CI: [-35.4, -22.1]ANCOVA
Secondary
Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment
Participants were analyzed to evaluate the LDL-C target of \<100 mg/dL for high risk participants with cardiovascular diseases. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Time frame: Baseline; up to 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETC-1002 | Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Week 8: Achieved LDL-C Goal | 21 Participants |
| ETC-1002 | Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Week 8: Did Not Achieve LDL-C Goal | 13 Participants |
| Placebo | Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Week 8: Achieved LDL-C Goal | 0 Participants |
| Placebo | Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Week 8: Did Not Achieve LDL-C Goal | 17 Participants |
p-value: <0.000195% CI: [45.4, 78.1]Fisher Exact
Secondary
Number of Participants With Muscle-Related TEAEs
TEAEs were defined as AEs that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication.
Time frame: up to 8 weeks
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ETC-1002 | Number of Participants With Muscle-Related TEAEs | 12 Participants |
| Placebo | Number of Participants With Muscle-Related TEAEs | 7 Participants |
Secondary
Number or Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication.
Time frame: up to 8 weeks
Population: Safety Population: all randomized participants who received at least 1 dose of study medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ETC-1002 | Number or Participants With Treatment-emergent Adverse Events (TEAEs) | 26 Participants |
| Placebo | Number or Participants With Treatment-emergent Adverse Events (TEAEs) | 15 Participants |
Secondary
Percent Change From Baseline to Week 8 in Apolipoprotein AI
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Apolipoprotein AI | -4.2 Percent Change | Standard Error 2.04 |
| Placebo | Percent Change From Baseline to Week 8 in Apolipoprotein AI | 0.1 Percent Change | Standard Error 2.98 |
p-value: =0.255595% CI: [-11.7, 3.2]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in Apolipoprotein B
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Apolipoprotein B | -19.7 Percent Change | Standard Error 2.61 |
| Placebo | Percent Change From Baseline to Week 8 in Apolipoprotein B | -4.4 Percent Change | Standard Error 3.77 |
p-value: =0.001995% CI: [-24.6, -6]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA)
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA) | 14.3 Percent Change | Standard Error 7.99 |
| Placebo | Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA) | 10.4 Percent Change | Standard Error 11.31 |
p-value: 0.77695% CI: [-24.1, 32]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C)
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C) | -8.2 Percent Change | Standard Deviation 2.46 |
| Placebo | Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C) | -2.4 Percent Change | Standard Deviation 3.51 |
p-value: 0.189295% CI: [-14.5, 2.9]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP)
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. hsCRP results indicated as \<0.2 in the laboratory data were set to 0.2 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP) | -22.6 Percent Change | Standard Error 11.77 |
| Placebo | Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP) | 1.1 Percent Change | Standard Error 16.74 |
p-value: 0.256595% CI: [-65.4, 18]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in Lipoprotein (a)
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data are based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. Lipoprotein (a) results indicated as \<3 in the laboratory data were set to 3 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Lipoprotein (a) | 10.4 Percent Change | Standard Error 5.78 |
| Placebo | Percent Change From Baseline to Week 8 in Lipoprotein (a) | -1.2 Percent Change | Standard Error 8.32 |
p-value: 0.256395% CI: [-8.8, 32.1]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in Non-HDL-C
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Non-HDL-C | -25.4 Percent Change | Standard Error 2.04 |
| Placebo | Percent Change From Baseline to Week 8 in Non-HDL-C | -4.4 Percent Change | Standard Error 2.88 |
p-value: <0.000195% CI: [-28, -13.9]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in Total Cholesterol
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Total Cholesterol | -22.2 Percent Change | Standard Error 1.64 |
| Placebo | Percent Change From Baseline to Week 8 in Total Cholesterol | -3.7 Percent Change | Standard Error 2.32 |
p-value: <0.000195% CI: [-24.2, -12.7]ANCOVA
Secondary
Percent Change From Baseline to Week 8 in Triglycerides
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; 8 weeks
Population: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Week 8 in Triglycerides | 11.2 Percent Change | Standard Error 6.34 |
| Placebo | Percent Change From Baseline to Week 8 in Triglycerides | -7.4 Percent Change | Standard Error 8.98 |
p-value: =0.096295% CI: [-3.5, 40.8]ANCOVA
Secondary
Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. A negative percent change from Baseline reflects clinical improvement.
Time frame: Baseline; Weeks 2, 4, 6, and 8
Population: Completers Population: All randomized participants who received at least 1 dose of study medication and had a Baseline assessment and an assessment at the specified time point, excluding any assessments taken more than 2 days after a dose of study medication. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| ETC-1002 | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 2 | -19.5 Percent Change | Standard Error 1.83 |
| ETC-1002 | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 6 | -32.6 Percent Change | Standard Error 2.28 |
| ETC-1002 | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 4 | -31.0 Percent Change | Standard Error 1.5 |
| ETC-1002 | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 8 | -32.6 Percent Change | Standard Error 2.48 |
| Placebo | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 8 | -4.0 Percent Change | Standard Error 3.51 |
| Placebo | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 2 | -1.4 Percent Change | Standard Error 2.52 |
| Placebo | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 4 | -1.0 Percent Change | Standard Error 2.12 |
| Placebo | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Week 6 | -3.8 Percent Change | Standard Error 3.28 |
p-value: <0.000195% CI: [-24.3, -11.8]ANCOVA
p-value: <0.000195% CI: [-35.2, -24.7]ANCOVA
p-value: <0.000195% CI: [-36.9, -20.8]ANCOVA
p-value: <0.000195% CI: [-37.2, -19.8]ANCOVA