Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility) (NCT NCT03001076)

Last Updated: 2020-05-11

Results Overview

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 the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. Bempedoic Acid = BA. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

269 participants

Primary outcome timeframe

Week 12

Results posted on

2020-05-11

Participant Flow

Out of the 269 participants who were randomized to the double-blind treatment period, 181 participants were randomized to bempedoic acid and 88 participants to placebo. One participant in the placebo group was randomized but never started treatment.

The study consisted of an approximate 1-week screening period, a 4-week single-blind placebo and ezetimibe run-in period, and a 12-week double-blind treatment period.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Overall Study STARTED	88	181
Overall Study COMPLETED	81	176
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Overall Study Withdrawal by patient	2	0
Overall Study Other	1	0
Overall Study Adverse Event	3	3
Overall Study Sponsor decision	1	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Only participants with available data were analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Total n=269 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 11.32 • n=88 Participants	63.8 years STANDARD_DEVIATION 10.77 • n=181 Participants	63.8 years STANDARD_DEVIATION 10.93 • n=269 Participants
Sex: Female, Male Female	56 Participants n=88 Participants	109 Participants n=181 Participants	165 Participants n=269 Participants
Sex: Female, Male Male	32 Participants n=88 Participants	72 Participants n=181 Participants	104 Participants n=269 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=88 Participants	43 Participants n=181 Participants	66 Participants n=269 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=88 Participants	138 Participants n=181 Participants	203 Participants n=269 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=88 Participants	0 Participants n=181 Participants	0 Participants n=269 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=88 Participants	0 Participants n=181 Participants	0 Participants n=269 Participants
Race (NIH/OMB) Asian	1 Participants n=88 Participants	3 Participants n=181 Participants	4 Participants n=269 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=88 Participants	2 Participants n=181 Participants	2 Participants n=269 Participants
Race (NIH/OMB) Black or African American	10 Participants n=88 Participants	11 Participants n=181 Participants	21 Participants n=269 Participants
Race (NIH/OMB) White	75 Participants n=88 Participants	165 Participants n=181 Participants	240 Participants n=269 Participants
Race (NIH/OMB) More than one race	2 Participants n=88 Participants	0 Participants n=181 Participants	2 Participants n=269 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=88 Participants	0 Participants n=181 Participants	0 Participants n=269 Participants
LDL-C category <130 mg/dL	56 Participants n=88 Participants	99 Participants n=181 Participants	155 Participants n=269 Participants
LDL-C category ≥130 to <160 mg/dL	24 Participants n=88 Participants	53 Participants n=181 Participants	77 Participants n=269 Participants
LDL-C category ≥160 mg/dL	8 Participants n=88 Participants	29 Participants n=181 Participants	37 Participants n=269 Participants
Concomitant lipid-modifying therapy medications Statins	25 Participants n=88 Participants	59 Participants n=181 Participants	84 Participants n=269 Participants
Concomitant lipid-modifying therapy medications Fibrates	3 Participants n=88 Participants	7 Participants n=181 Participants	10 Participants n=269 Participants
Concomitant lipid-modifying therapy medications Nicotinic acid and derivatives	4 Participants n=88 Participants	3 Participants n=181 Participants	7 Participants n=269 Participants
Concomitant lipid-modifying therapy medications Bile acid sequestrants	1 Participants n=88 Participants	1 Participants n=181 Participants	2 Participants n=269 Participants
Concomitant lipid-modifying therapy medications Other lipid-modifying therapies	8 Participants n=88 Participants	19 Participants n=181 Participants	27 Participants n=269 Participants
Concomitant lipid-modifying therapy medications No concomitant lipid-modifying therapies	47 Participants n=88 Participants	92 Participants n=181 Participants	139 Participants n=269 Participants
Concomitant illness: Cardiac disorder Participants with cardiac disorder	22 Participants n=88 Participants	49 Participants n=181 Participants	71 Participants n=269 Participants
Concomitant illness: Cardiac disorder Participants without cardiac disorder	66 Participants n=88 Participants	132 Participants n=181 Participants	198 Participants n=269 Participants
History of diabetes Participants with history of diabetes	17 Participants n=88 Participants	35 Participants n=181 Participants	52 Participants n=269 Participants
History of diabetes Participants without history of diabetes	71 Participants n=88 Participants	146 Participants n=181 Participants	217 Participants n=269 Participants
History of hypertension Participants with history of hypertension	51 Participants n=88 Participants	111 Participants n=181 Participants	162 Participants n=269 Participants
History of hypertension Participants without history of hypertension	37 Participants n=88 Participants	70 Participants n=181 Participants	107 Participants n=269 Participants
Estimated glomerular filtration rate (eGFR) category ≥90 mL/min/1.73m2	17 Participants n=88 Participants	45 Participants n=181 Participants	62 Participants n=269 Participants
Estimated glomerular filtration rate (eGFR) category 60 to <90 mL/min/1.73m2	57 Participants n=88 Participants	110 Participants n=181 Participants	167 Participants n=269 Participants
Estimated glomerular filtration rate (eGFR) category <60 mL/min/1.73m2	14 Participants n=88 Participants	26 Participants n=181 Participants	40 Participants n=269 Participants
Low-density lipoprotein cholesterol (LDL-C)	123.02 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.197 • n=88 Participants	129.77 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 30.871 • n=181 Participants	127.56 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 29.838 • n=269 Participants
Non-high-density lipoprotein cholesterol (non-HDL-C)	151.55 mg/dL STANDARD_DEVIATION 32.734 • n=88 Participants	162.41 mg/dL STANDARD_DEVIATION 35.413 • n=181 Participants	158.85 mg/dL STANDARD_DEVIATION 34.874 • n=269 Participants
Total cholesterol (TC)	208.62 mg/dL STANDARD_DEVIATION 35.712 • n=88 Participants	218.24 mg/dL STANDARD_DEVIATION 35.883 • n=181 Participants	215.09 mg/dL STANDARD_DEVIATION 36.045 • n=269 Participants
Apolipoprotein B (apoB)	115.8 mg/dL STANDARD_DEVIATION 23.47 • n=86 Participants • Only participants with available data were analyzed.	123.3 mg/dL STANDARD_DEVIATION 26.48 • n=180 Participants • Only participants with available data were analyzed.	120.9 mg/dL STANDARD_DEVIATION 25.75 • n=266 Participants • Only participants with available data were analyzed.
High-sensitivity C-reactive protein (hsCRP)	2.260 mg/dL n=86 Participants • Only participants with available data were analyzed.	2.205 mg/dL n=180 Participants • Only participants with available data were analyzed.	2.215 mg/dL n=266 Participants • Only participants with available data were analyzed.
Triglycerides (TGs)	143.39 mg/dL STANDARD_DEVIATION 61.932 • n=88 Participants	166.93 mg/dL STANDARD_DEVIATION 75.683 • n=181 Participants	159.23 mg/dL STANDARD_DEVIATION 72.213 • n=269 Participants
High-density lipoprotein cholesterol (HDL-C)	57.07 mg/dL STANDARD_DEVIATION 21.319 • n=88 Participants	55.84 mg/dL STANDARD_DEVIATION 16.326 • n=181 Participants	56.24 mg/dL STANDARD_DEVIATION 18.080 • n=269 Participants
Systolic blood pressure	126.0 millimeter of mercury (mmHg) STANDARD_DEVIATION 13.50 • n=88 Participants	127.3 millimeter of mercury (mmHg) STANDARD_DEVIATION 13.34 • n=181 Participants	126.9 millimeter of mercury (mmHg) STANDARD_DEVIATION 13.38 • n=269 Participants
Diastolic blood pressure	77.0 mmHg STANDARD_DEVIATION 7.56 • n=88 Participants	76.4 mmHg STANDARD_DEVIATION 8.46 • n=181 Participants	76.6 mmHg STANDARD_DEVIATION 8.17 • n=269 Participants
Body mass index (BMI)	30.45 kilograms per square meter (kg/m2) STANDARD_DEVIATION 5.787 • n=88 Participants	29.52 kilograms per square meter (kg/m2) STANDARD_DEVIATION 4.740 • n=181 Participants	29.83 kilograms per square meter (kg/m2) STANDARD_DEVIATION 5.114 • n=269 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all randomized participants

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)	4.99 percent change Standard Error 2.299	-23.46 percent change Standard Error 1.945

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. 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 in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	5.19 percent change Standard Error 2.202	-18.38 percent change Standard Error 1.668

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TC. Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. 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 in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)	2.88 Percent change Standard Error 1.553	-15.11 Percent change Standard Error 1.282

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for apoB. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: \[(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in apoB was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing apoB data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB)	4.74 Percent change Standard Error 1.786	-14.58 Percent change Standard Error 1.497

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for hsCRP. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: \[(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)\] multiplied by 100.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=175 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)	2.088 Percent change Interval -32.143 to 49.224	-32.521 Percent change Interval -55.556 to 10.714

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

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 the last two non-missing values on or prior to D 1. 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 in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=176 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in Triglycerides (TGs)	9.23 Percent change Standard Error 4.218	4.70 Percent change Standard Error 3.068

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

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 the last two non-missing values on or prior to Day 1. 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 in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=175 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)	-1.38 percent change Standard Error 1.389	-7.27 percent change Standard Error 1.214

SECONDARY outcome

Timeframe: Up to approximately 16 weeks

Population: Safety Analysis Set: all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group that they actually received, regardless of their randomized treatment.

TEAEs, defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious TEAEs	3 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Deaths	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) TEAEs	39 Participants	88 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Non-serious TEAEs	18 Participants	46 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: Full Analysis Set. Only participants with available data were analyzed.

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 the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(LDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Weeks 4 and 8 in LDL-C Week 4	3.05 Percent change Standard Error 1.442	-28.04 Percent change Standard Error 1.704
Percent Change From Baseline to Weeks 4 and 8 in LDL-C Week 8	3.61 Percent change Standard Error 1.773	-25.51 Percent change Standard Error 1.773

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: Full Analysis Set. Only participants with available data were analyzed.

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 the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(Non-HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Weeks 4 and 8 in Non-HDL-C Week 4	3.08 Percent change Standard Error 1.362	-22.17 Percent change Standard Error 1.457
Percent Change From Baseline to Weeks 4 and 8 in Non-HDL-C Week 8	3.71 Percent change Standard Error 1.660	-20.04 Percent change Standard Error 1.531

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: Full Analysis Set. Only participants with available data were analyzed.

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 the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(TC value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Weeks 4 and 8 in TC Week 4	2.08 Percent change Standard Error 1.000	-18.33 Percent change Standard Error 1.129
Percent Change From Baseline to Weeks 4 and 8 in TC Week 8	1.82 Percent change Standard Error 1.110	-16.63 Percent change Standard Error 1.215

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: Full Analysis Set. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TGs. Baseline was defined as the mean of the TGs values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(TGs value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Weeks 4 and 8 in TGs Week 8	7.68 Percent change Standard Error 4.246	7.60 Percent change Standard Error 2.849
Percent Change From Baseline to Weeks 4 and 8 in TGs Week 4	6.00 Percent change Standard Error 4.273	5.20 Percent change Standard Error 2.536

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4 and Week 8

Population: Full Analysis Set. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for HDL-C. Baseline was defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Percent Change From Baseline to Weeks 4 and 8 in HDL-C Week 4	0.85 Percent change Standard Error 1.204	-7.73 Percent change Standard Error 1.081
Percent Change From Baseline to Weeks 4 and 8 in HDL-C Week 8	-1.33 Percent change Standard Error 1.272	-7.75 Percent change Standard Error 1.144

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4, Week 8 and Week 12

Population: Full Analysis Set. Only participants with available data were analyzed.

Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Absolute change from baseline was calculated as: LDL-C value at Week 4, 8, or 12 minus Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 Participants Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Absolute Change From Baseline to Weeks 4, 8, and 12 in LDL-C Change from Baseline at Week 4	3.6 milligrams per deciliter (mg/dL) Standard Deviation 15.65	-37.4 milligrams per deciliter (mg/dL) Standard Deviation 30.90
Absolute Change From Baseline to Weeks 4, 8, and 12 in LDL-C Change from Baseline at Week 8	3.9 milligrams per deciliter (mg/dL) Standard Deviation 19.22	-34.5 milligrams per deciliter (mg/dL) Standard Deviation 32.29
Absolute Change From Baseline to Weeks 4, 8, and 12 in LDL-C Change from Baseline at Week 12	5.3 milligrams per deciliter (mg/dL) Standard Deviation 23.96	-32.9 milligrams per deciliter (mg/dL) Standard Deviation 34.14

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Bempedoic Acid

Serious events: 5 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=87 participants at risk Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 participants at risk Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.55% 1/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Infections and infestations Bronchitis	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.55% 1/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Infections and infestations Pneumonia bacterial	1.1% 1/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Injury, poisoning and procedural complications Poisoning deliberate	1.1% 1/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Injury, poisoning and procedural complications Subdural haematoma	1.1% 1/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Injury, poisoning and procedural complications Subdural haemorrhage	1.1% 1/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.55% 1/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.1% 1/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.55% 1/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Nervous system disorders Syncope	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.55% 1/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Renal and urinary disorders Dysuria	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.55% 1/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.

Other adverse events

Other adverse events
Measure	Placebo n=87 participants at risk Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.	Bempedoic Acid n=181 participants at risk Participants received placebo tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 4 weeks prior to the 12-week treatment period. During the treatment period, participants received bempedoic acid 180 mg tablet, once-daily by mouth and ezetimibe 10 mg capsules, once-daily by mouth for 12 weeks.
Ear and labyrinth disorders Vertigo	2.3% 2/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Gastrointestinal disorders Nausea	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	2.8% 5/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Infections and infestations Nasopharyngitis	1.1% 1/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	2.2% 4/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Infections and infestations Urinary tract infection	5.7% 5/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	2.8% 5/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Infections and infestations Sinusitis	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	2.8% 5/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Infections and infestations Vulvovaginal mycotic infection	2.3% 2/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	0.00% 0/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Investigations Blood uric acid increase	2.3% 2/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	7.7% 14/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Investigations Liver function test increased	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	3.9% 7/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Investigations Glomerular filtration rate decreased	0.00% 0/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	2.2% 4/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Metabolism and nutrition disorders Diabetes mellitus	2.3% 2/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	1.1% 2/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Myalgia	2.3% 2/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	1.7% 3/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Musculoskeletal and connective tissue disorders Muscle spasms	3.4% 3/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	3.3% 6/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.
Nervous system disorders Headache	3.4% 3/87 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.	4.4% 8/181 • Up to approximately 16 weeks Treatment-emergent adverse events (TEAEs), defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. The analysis was performed using the Safety Analysis Set.

Additional Information

Medical Director

Esperion Therapeutics, Inc.

Phone: 1-833-377-7633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
Publication restrictions are in place

Restriction type: OTHER