CompletedNCT05694260CLEAR Path 1Updated Jul 17, 2026Results posted

A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)

A Phase 2 interventional study of Bempedoic acid in Hypercholesterolemia, sponsored by Esperion Therapeutics, Inc.. Completed at 24 sites in 6 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Esperion Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 31
Allocation: Non-randomized
Ages: 6 Years to 17 Years
Sex: All

Study summary

Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.

Read the detailed description

Dose-selection based on body weight will be determined for use in pediatric clinical development.

Conditions studied

Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,238

Keywords

Pediatric
Heterozygous familial hypercholesterolemia
Low-density lipoprotein cholesterol (LDL-cholesterol)
Bempedoic acid
ETC-1002
Adenosine triphosphate citrate lyase

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 31 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Esperion Therapeutics, Inc. is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

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

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participant's parent(s)/guardian(s) must be willing to provide written informed consent and the participant must provide informed assent before any study-specific procedures are performed;
Participant must be aged 6-17 years old and willing to swallow tablets;
Participant must weigh at least 16 kilograms (kg);
Participant must have a diagnosis of HeFH prior to receiving the first dose of study medication at Treatment Visit T1 per Make Early Diagnosis to Prevent Early Deaths project (MEDPED) criteria by meeting at least one of the following clinical criteria:
1. Documented diagnosis of HeFH determined by positive genetic testing; or
2. Documented LDL-C or TC meeting one or more of the following criteria:
i. LDL-C >200 milligrams per deciliter (mg/dL) (5.2 millimole per liter [mmol/L]) or TC >270 mg/dL (7.0 mmol/L), with no first- second- or third-degree relative with documented FH diagnosis (general population); or ii. LDL-C >155 mg/dL (4.0 mmol/L) or TC >220 mg/dL (5.7 mmol/L), and also having a first-degree relative with documented familial hypercholesterolemia (FH) diagnosis; or iii. LDL-C >165 mg/dL (4.3 mmol/L) or TC >230 mg/dL (5.9 mmol/L), and also having a second-degree relative with documented FH diagnosis; or iv. LDL-C >170 mg/dL (4.4 mmol/L) or TC >240 mg/dL (6.2 mmol/L), and also having a third-degree relative with documented FH diagnosis
Current treatment with approved stable lipid-modifying therapy (LMT), including an optimal dose of statin with or without other LMT(s), at stable dose for at least 4 weeks prior to Treatment Visit T1 (6 weeks for fibrates; however, gemfibrozil is not allowed in participants taking a statin as per coadministration instructions defined in the statin label). Participants must remain on that stable dose throughout the duration of the trial. Optimal dose of statin will be determined by the investigator using their medical judgment and available sources, including the participant's self-reported history of LMT. A participant's optimal dose of statin is defined as meeting one of the following criteria:
1. the highest approved dose of statin prescribed for the age of the participant based on regional practice or local guidelines; or
2. less than the highest approved dose of statin, including no statin, prescribed for the age of the participant based on regional practice or local guidelines (including no statin) if: i. the participant has previously taken 2 or more statin therapies at any dose and not able to tolerate or unresponsive due to their mutations (null); or ii. the participant has previously taken 1 or more statin therapies at any dose and is unwilling to attempt another statin at any dose or advised by a physician to not attempt another statin at any dose.
3. Participant/parent and investigator attestation to the participant's unwillingness to attempt and/or physician advice to not attempt additional statin therapy will be recorded.

Exclusion criteria

Exclusion Criteria:

Participant has a diagnosis of homozygous familial hypercholesterolemia (HoFH) or compound HeFH;
Participant has a fasting triglyceride (TG) level ≥400 mg/dL (4.5 mmol/L);
Participant has uncontrolled hypothyroidism, including a value for thyroid-stimulating hormone (TSH) \< lower limit of normal (LLN) or >1.5 × the upper limit of normal (ULN);
Participant has liver disease or dysfunction, including:
1. positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus antibodies (HCV-AB), or
2. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥2 × ULN and/or serum total bilirubin (TB) value ≥2 × ULN. If the serum TB value is ≥1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained and, if consistent with Gilbert's disease or if the participant has a history of Gilbert's disease, the participant may be enrolled in the study.
Participant has renal dysfunction or glomerulonephritis, including an estimated glomerular filtration rate (eGFR) \<75 milliliters/minute/1.73 square meter (mL/min/1.73 m\^2).

Other protocol defined inclusion and exclusion criteria.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Experimental
Cohort 1
Participants at 16 to \<30 kilograms (kg) body weight at screening receiving once daily 60 milligrams (mg) bempedoic acid for 8 weeks followed by 90 mg bempedoic acid for 8 weeks.
Drug: Bempedoic acid
Experimental
Cohort 2
Participants at 30 to 60 kg body weight at screening receiving once daily120 mg bempedoic acid for 8 weeks followed by 150 mg bempedoic acid for 8 weeks.
Drug: Bempedoic acid
Experimental
Cohort 3
Participants at greater than 60 kg body weight at screening receiving once daily 180 mg bempedoic acid for 8 weeks.
Drug: Bempedoic acid

Interventions

DrugBempedoic acid
Once daily oral dosing with oral tablets.
Also known as: ETC-1002

What researchers measure

Primary outcomes

Observed Trough Plasma Concentration of ETC-1002 Following 8 Weeks of Steady State Dosing of Bempedoic Acid
Blood plasma samples were collected and analyzed to determine the plasma trough concentration of ETC-1002 following 8 weeks of steady-state dosing of bempedoic acid. The data presented here is for participants who received tablet formulation only.
Time frame: Week 8 pre-dose
Model-based Steady State Area Under the Concentration-time Curve Over 24 Hours (AUC,24ss) of ETC-1002
Blood plasma samples were collected and analyzed to determine the AUC,24ss of ETC-1002 over 24 hours. The data presented here is for participants who received tablet formulation only.
Time frame: 24 hours
Model-based Steady State Average Plasma Concentration (Cavg,ss) of ETC-1002
Blood plasma samples were collected and analyzed to determine the Cavg,ss of ETC-1002. Cavg was calculated by empirical Bayesian estimated pediatric exposure over 24 hours divided by 24 (AUC24hr.ss / 24). The data presented here is for participants who received tablet formulation only.
Time frame: Week 8, 24 hours post-dose at steady state
Model-based Steady State Maximum Plasma Concentration (Cmax,ss) of ETC-1002
Blood plasma samples were collected and analyzed to determine the Cmax,ss of ETC-1002. The data presented here is for participants who received tablet formulation only.
Time frame: Day 1: 1-hour and 4 hours post-dose; Week 4 pre-dose; Week 8 pre-dose

Secondary outcomes

Observed Trough Plasma Concentration of ESP15228
Blood plasma samples were collected and analyzed to determine the trough plasma concentration of active metabolite ESP15228 following 8 weeks of steady-state dosing of bempedoic acid. The data presented here is for participants who received tablet formulation only.
Time frame: Week 8 pre-dose
Observed Plasma Concentration at 4 Hours (C4hr) of ETC-1002
Blood plasma samples were collected and analyzed to determine the trough plasma concentration of ETC-1002 4 hours post-dose. The data presented here is for participants who received tablet formulation only.
Time frame: Day 1: 4 hours post-dose
Observed C4hr of ESP15228
Blood plasma samples were collected and analyzed to determine the trough plasma concentration of active metabolite ESP15228 4 hours post-dose on Day 1. The data presented here is for participants who received tablet formulation only.
Time frame: Day 1: 4 hours post-dose
Simulated Percent Change From Baseline in Exposure/ Low-Density Lipoprotein-Cholesterol (LDL-C)
Blood samples were collected for the analysis of and exposure/LDL-C-lowering response relationship.
Time frame: Baseline and Week 12
Observed Percent Change From Baseline in LDL-C
Blood samples were collected for analysis of LDL-C levels. Baseline is defined as the last assessment measurements before the first dose of investigational medical product (IMP). Percent change from baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Absolute Change From Baseline in LDL-C (mg/dl)
Blood samples were collected for analysis of LDL-C levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from baseline is defined as post- dose visit value minus baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Blood samples were collected for analysis of Non-HDL-C levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Absolute Change From Baseline in Non-HDL-C (mg/dL)
Blood samples were collected for analysis of Non-HDL-C levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from Baseline is defined as post- dose visit value minus Baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Percent Change From Baseline in Total Cholesterol (TC)
Blood samples were collected for analysis of total cholesterol levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Absolute Change From Baseline in TC (mg/dL)
Blood samples were collected for analysis of TC levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from Baseline is defined as post- dose visit value minus Baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Blood samples were collected for analysis of hsCRP. Baseline is defined as the last assessment measurements before the first dose of IMP. Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Observed Absolute Change From Baseline in hsCRP (mg/L)
Blood samples were collected for analysis of hsCRP levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from Baseline is defined as post- dose visit value minus Baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.
Time frame: Baseline and 8 Weeks post-treatment
Acceptability of Taste of Liquid Formulation Using a Dosing Acceptability Questionnaire
Participant acceptance is defined as the overall ability of the participant to use a medicine as intended. The acceptability of overall flavor of IMP was recorded using a dosing acceptability questionnaire, where participants were asked 'Yes' or 'No', whether the flavor of the medication was acceptable. At Week 8 (Phone) participants in cohorts 1 and 2 were contacted by phone to collect questionnaire information. The number of participants who have responded at each time point have been presented.
Time frame: Days 1 and 2; Weeks 2, 4, 8, 8 (Phone), 10, 12, and 16
Acceptability of Ease of Swallowing Tablet Formulation Using a Dosing Acceptability Questionnaire
Participant acceptance is defined as the overall ability of the participant to use a medicine as intended. Acceptability of ease of swallowing was recorded using a dosing acceptability questionnaire where participants were asked if they were able to swallow the entire dose or not, by ticking 'yes' or 'no'. At Week 8 (Phone) participants in cohorts 1 and 2 were contacted by phone to collect questionnaire information. The number of participants who responded at each time point have been presented.
Time frame: Days 1 and 2; Weeks 2, 4, 8, 8 (Phone), 10, 12, and 16
Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A serious AE is an AE occurring during any study phase (i.e., baseline, treatment, washout, or follow-up), and at any dose of the study medication that fulfills one or more of the following: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital abnormality or birth defect, is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 16

Results

Posted Jul 17, 2026

Participant flow

This was a multi-dose study to measure the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bempedoic acid in pediatric participants aged 6 to 17 years with heterozygous familial hypercholesterolemia (HeFH).

Treatment Period 1 (Up to Week 8)

Participant flow — Treatment Period 1 (Up to Week 8)
Milestone	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Started	4	16	11
Completed	4	15	11
Not completed	0	1	0
Withdrew: Protocol deviation	0	1	0

Treatment Period 2 (Week 8 to Week 16)

Participant flow — Treatment Period 2 (Week 8 to Week 16)
Milestone	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg
Started	4	14
Completed	4	14
Not completed	0	0

Outcome measures

PrimaryObserved Trough Plasma Concentration of ETC-1002 Following 8 Weeks of Steady State Dosing of Bempedoic Acid

Blood plasma samples were collected and analyzed to determine the plasma trough concentration of ETC-1002 following 8 weeks of steady-state dosing of bempedoic acid. The data presented here is for participants who received tablet formulation only.

Time frame:: Week 8 pre-dose
Reported as:: Geometric mean · nanograms/milliliter (ng/ml)

Observed Trough Plasma Concentration of ETC-1002 Following 8 Weeks of Steady State Dosing of Bempedoic Acid
nanograms/milliliter (ng/ml)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Trough Plasma Concentration of ETC-1002 Following 8 Weeks of Steady State Dosing of Bempedoic Acid	5740 ± 39.6	10189 ± 20.4	7174 ± 156.6	15356 ± 95.0	7123 ± 122.9

PrimaryModel-based Steady State Area Under the Concentration-time Curve Over 24 Hours (AUC,24ss) of ETC-1002

Blood plasma samples were collected and analyzed to determine the AUC,24ss of ETC-1002 over 24 hours. The data presented here is for participants who received tablet formulation only.

Time frame:: 24 hours
Reported as:: Mean · milligram hours per liter (mg*h/L)

Model-based Steady State Area Under the Concentration-time Curve Over 24 Hours (AUC,24ss) of ETC-1002
milligram hours per liter (mg*h/L)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Model-based Steady State Area Under the Concentration-time Curve Over 24 Hours (AUC,24ss) of ETC-1002	305.1 ± 56.03	419.4 ± 42.43	348.0 ± 141.3	443.8 ± 183.6	296.2 ± 110.0

PrimaryModel-based Steady State Average Plasma Concentration (Cavg,ss) of ETC-1002

Blood plasma samples were collected and analyzed to determine the Cavg,ss of ETC-1002. Cavg was calculated by empirical Bayesian estimated pediatric exposure over 24 hours divided by 24 (AUC24hr.ss / 24). The data presented here is for participants who received tablet formulation only.

Time frame:: Week 8, 24 hours post-dose at steady state
Reported as:: Mean · milligrams per liter (mg/L)

Model-based Steady State Average Plasma Concentration (Cavg,ss) of ETC-1002
milligrams per liter (mg/L)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Model-based Steady State Average Plasma Concentration (Cavg,ss) of ETC-1002	12.7 ± 2.33	17.5 ± 1.77	14.5 ± 5.89	18.5 ± 7.65	12.3 ± 4.58

PrimaryModel-based Steady State Maximum Plasma Concentration (Cmax,ss) of ETC-1002

Blood plasma samples were collected and analyzed to determine the Cmax,ss of ETC-1002. The data presented here is for participants who received tablet formulation only.

Time frame:: Day 1: 1-hour and 4 hours post-dose; Week 4 pre-dose; Week 8 pre-dose
Reported as:: Mean · milligrams per liter (mg/L)

Model-based Steady State Maximum Plasma Concentration (Cmax,ss) of ETC-1002
milligrams per liter (mg/L)	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 Bempedoic Acid (> 60 Kg)
Model-based Steady State Maximum Plasma Concentration (Cmax,ss) of ETC-1002	20.25 ± 4.088	27.39 ± 1.736	22.49 ± 8.410	28.70 ± 10.89	19.10 ± 7.320

SecondaryObserved Trough Plasma Concentration of ESP15228

Blood plasma samples were collected and analyzed to determine the trough plasma concentration of active metabolite ESP15228 following 8 weeks of steady-state dosing of bempedoic acid. The data presented here is for participants who received tablet formulation only.

Time frame:: Week 8 pre-dose
Reported as:: Geometric mean · nanograms per milliliter (ng/ml)

Observed Trough Plasma Concentration of ESP15228
nanograms per milliliter (ng/ml)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Trough Plasma Concentration of ESP15228	1270 ± 30.2	1982 ± 13.1	1596 ± 102.0	2690 ± 52.2	1305 ± 81.5

SecondaryObserved Plasma Concentration at 4 Hours (C4hr) of ETC-1002

Blood plasma samples were collected and analyzed to determine the trough plasma concentration of ETC-1002 4 hours post-dose. The data presented here is for participants who received tablet formulation only.

Time frame:: Day 1: 4 hours post-dose
Reported as:: Geometric mean · ng/ml

Observed Plasma Concentration at 4 Hours (C4hr) of ETC-1002
ng/ml	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Plasma Concentration at 4 Hours (C4hr) of ETC-1002	8215 ± 21.2	16500 ± 13.4	11047 ± 28.2	20757 ± 38.1	9355 ± 61.0

SecondaryObserved C4hr of ESP15228

Blood plasma samples were collected and analyzed to determine the trough plasma concentration of active metabolite ESP15228 4 hours post-dose on Day 1. The data presented here is for participants who received tablet formulation only.

Time frame:: Day 1: 4 hours post-dose
Reported as:: Geometric mean · ng/ml

Observed C4hr of ESP15228
ng/ml	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed C4hr of ESP15228	715 ± 23.0	2395 ± 39.4	661 ± 39.0	2601 ± 54.2	741 ± 32.6

SecondarySimulated Percent Change From Baseline in Exposure/ Low-Density Lipoprotein-Cholesterol (LDL-C)

Blood samples were collected for the analysis of and exposure/LDL-C-lowering response relationship.

Time frame:: Baseline and Week 12
Reported as:: Mean · percent change

Simulated Percent Change From Baseline in Exposure/ Low-Density Lipoprotein-Cholesterol (LDL-C)
percent change	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Simulated Percent Change From Baseline in Exposure/ Low-Density Lipoprotein-Cholesterol (LDL-C)	-23.5 ± 12.1	-23.9 ± 12.5	-22.5 ± 11.2

SecondaryObserved Percent Change From Baseline in LDL-C

Blood samples were collected for analysis of LDL-C levels. Baseline is defined as the last assessment measurements before the first dose of investigational medical product (IMP). Percent change from baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Mean · percent change

Observed Percent Change From Baseline in LDL-C
percent change	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Percent Change From Baseline in LDL-C	-21.1 ± 29.2	-24.9 ± 10.4	-5.7 ± 16.6	-12.9 ± 18.7	-8.0 ± 23.9

SecondaryObserved Absolute Change From Baseline in LDL-C (mg/dl)

Blood samples were collected for analysis of LDL-C levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from baseline is defined as post- dose visit value minus baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Mean · milligrams per deciliter (mg/dl)

Observed Absolute Change From Baseline in LDL-C (mg/dl)
milligrams per deciliter (mg/dl)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Absolute Change From Baseline in LDL-C (mg/dl)	-49.0 ± 63.06	-47.3 ± 17.95	-10.1 ± 29.45	-23.5 ± 33.97	-12.8 ± 38.20

SecondaryObserved Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

Blood samples were collected for analysis of Non-HDL-C levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Mean · percent change

Observed Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
percent change	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	-21.7 ± 26.1	-24.7 ± 9.8	-4.4 ± 14.1	-10.6 ± 19.0	-5.8 ± 20.6

SecondaryObserved Absolute Change From Baseline in Non-HDL-C (mg/dL)

Blood samples were collected for analysis of Non-HDL-C levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from Baseline is defined as post- dose visit value minus Baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Mean · mg/dL

Observed Absolute Change From Baseline in Non-HDL-C (mg/dL)
mg/dL	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Absolute Change From Baseline in Non-HDL-C (mg/dL)	-51.0 ± 57.64	-49.0 ± 15.72	-8.9 ± 28.65	-22.1 ± 35.48	-10.7 ± 37.02

SecondaryObserved Percent Change From Baseline in Total Cholesterol (TC)

Blood samples were collected for analysis of total cholesterol levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Mean · percent change

Observed Percent Change From Baseline in Total Cholesterol (TC)
percent change	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Percent Change From Baseline in Total Cholesterol (TC)	-17.4 ± 21.1	-20.0 ± 11.2	-4.5 ± 11.8	-9.2 ± 15.8	-5.0 ± 17.3

SecondaryObserved Absolute Change From Baseline in TC (mg/dL)

Blood samples were collected for analysis of TC levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from Baseline is defined as post- dose visit value minus Baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Mean · mg/dL

Observed Absolute Change From Baseline in TC (mg/dL)
mg/dL	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Absolute Change From Baseline in TC (mg/dL)	-53.5 ± 62.85	-51.3 ± 24.03	-11.4 ± 29.24	-24.9 ± 39.16	-12.4 ± 39.81

SecondaryObserved Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)

Blood samples were collected for analysis of hsCRP. Baseline is defined as the last assessment measurements before the first dose of IMP. Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Median · percent change

Observed Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
percent change	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)	0.0 (-30.0 to 233.3)	-20.0 (-60.0 to 650.0)	-16.7 (-70.8 to 75.0)	0.0 (-38.9 to 30.0)	-16.7 (-52.9 to 83.3)

SecondaryObserved Absolute Change From Baseline in hsCRP (mg/L)

Blood samples were collected for analysis of hsCRP levels. Baseline is defined as the last assessment measurements before the first dose of IMP. Change from Baseline is defined as post- dose visit value minus Baseline value. The treatment period for participants in cohort 1 (60 mg), cohort 2 (120 mg), and cohort 3 was weeks 1-8. The treatment period for participants in cohort 1 (90 mg) and cohort 2 (150 mg) was weeks 8-16.

Time frame:: Baseline and 8 Weeks post-treatment
Reported as:: Median · milligrams per liter (mg/L)

Observed Absolute Change From Baseline in hsCRP (mg/L)
milligrams per liter (mg/L)	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
Observed Absolute Change From Baseline in hsCRP (mg/L)	0.00 (-0.03 to 0.70)	-0.06 (-0.10 to 0.26)	-0.02 (-0.26 to 0.10)	0.00 (-0.10 to 0.03)	-0.10 (-1.70 to 0.50)

SecondaryAcceptability of Taste of Liquid Formulation Using a Dosing Acceptability Questionnaire

Participant acceptance is defined as the overall ability of the participant to use a medicine as intended. The acceptability of overall flavor of IMP was recorded using a dosing acceptability questionnaire, where participants were asked 'Yes' or 'No', whether the flavor of the medication was acceptable. At Week 8 (Phone) participants in cohorts 1 and 2 were contacted by phone to collect questionnaire information. The number of participants who have responded at each time point have been presented.

Time frame:: Days 1 and 2; Weeks 2, 4, 8, 8 (Phone), 10, 12, and 16
Reported as:: Count of participants · Participants

Acceptability of Taste of Liquid Formulation Using a Dosing Acceptability Questionnaire
Participants	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 3 Bempedoic Acid (> 60 Kg)
Day 1 was the flavor of the medication acceptable? — Yes	1	5	5
Day 1 was the flavor of the medication acceptable? — No	0	2	0
Day 2 was the flavor of the medication acceptable? — Yes	0	5	4
Day 2 was the flavor of the medication acceptable? — No	0	1	0
Week 2 was the flavor of the medication acceptable? — Yes	0	4	4
Week 2 was the flavor of the medication acceptable? — No	0	1	0
Week 4 was the flavor of the medication acceptable? — Yes	0	4	4
Week 4 was the flavor of the medication acceptable? — No	0	0	0
Week 8 was the flavor of the medication acceptable? — Yes	0	4	3
Week 8 was the flavor of the medication acceptable? — No	0	0	0
Week 8 (Phone) was the flavor of the medication acceptable? — Yes	0	4	0
Week 8 (Phone) was the flavor of the medication acceptable? — No	0	0	0
Week 10 was the flavor of the medication acceptable? — Yes	0	4	0
Week 10 was the flavor of the medication acceptable? — No	0	0	0
Week 12 was the flavor of the medication acceptable? — Yes	0	4	0
Week 12 was the flavor of the medication acceptable? — No	0	0	0
Week 16 was the flavor of the medication acceptable? — Yes	0	4	0
Week 16 was the flavor of the medication acceptable? — No	0	0	0

SecondaryAcceptability of Ease of Swallowing Tablet Formulation Using a Dosing Acceptability Questionnaire

Participant acceptance is defined as the overall ability of the participant to use a medicine as intended. Acceptability of ease of swallowing was recorded using a dosing acceptability questionnaire where participants were asked if they were able to swallow the entire dose or not, by ticking 'yes' or 'no'. At Week 8 (Phone) participants in cohorts 1 and 2 were contacted by phone to collect questionnaire information. The number of participants who responded at each time point have been presented.

Time frame:: Days 1 and 2; Weeks 2, 4, 8, 8 (Phone), 10, 12, and 16
Reported as:: Count of participants · Participants

Acceptability of Ease of Swallowing Tablet Formulation Using a Dosing Acceptability Questionnaire
Participants	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 3 Bempedoic Acid (> 60 Kg)
Day 1 was the patient able to swallow the entire dose? — Yes	3	9	6
Day 1 was the patient able to swallow the entire dose? — No	0	0	0
Day 2 was the patient able to swallow the entire dose? — Yes	4	10	7
Day 2 was the patient able to swallow the entire dose? — No	0	0	0
Week 2 was the patient able to swallow the entire dose? — Yes	4	10	7
Week 2 was the patient able to swallow the entire dose? — No	0	0	0
Week 4 was the patient able to swallow the entire dose? — Yes	4	11	7
Week 4 was the patient able to swallow the entire dose? — No	0	0	0
Week 8 was the patient able to swallow the entire dose? — Yes	4	11	6
Week 8 was the patient able to swallow the entire dose? — No	0	0	0
Week 8 (Phone) was the patient able to swallow the entire dose? — Yes	3	9	0
Week 8 (Phone) was the patient able to swallow the entire dose? — No	0	0	0
Week 10 was the patient able to swallow the entire dose? — Yes	3	10	0
Week 10 was the patient able to swallow the entire dose? — No	0	0	0
Week 12 was the patient able to swallow the entire dose? — Yes	3	10	0
Week 12 was the patient able to swallow the entire dose? — No	0	0	0
Week 16 was the patient able to swallow the entire dose? — Yes	3	10	0
Week 16 was the patient able to swallow the entire dose? — No	0	0	0

SecondaryNumber of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs

An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A serious AE is an AE occurring during any study phase (i.e., baseline, treatment, washout, or follow-up), and at any dose of the study medication that fulfills one or more of the following: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in a congenital abnormality or birth defect, is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.

Time frame:: Up to Week 16
Reported as:: Count of participants · Participants

Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs
Participants	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
SAEs	0	0	0	0	0
Non-SAEs	3	3	10	10	9

Adverse events

Collected over Up to Week 16. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	0/4 (0%)	0/4 (0%)	3/4 (75%)
Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	0/3 (0%)	0/3 (0%)	3/3 (100%)
Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	0/16 (0%)	0/16 (0%)	10/16 (62.5%)
Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	0/14 (0%)	0/14 (0%)	10/14 (71.4%)
Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg	0/11 (0%)	0/11 (0%)	9/11 (81.8%)

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg	Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 120 mg	Cohort 2 (30 to 60 Kg) Bempedoic Acid 150 mg	Cohort 3 (> 60 Kg) Bempedoic Acid 180 mg
NasopharyngitisInfections and infestations	0/4	1/3	2/16	3/14	1/11
Ear infectionInfections and infestations	0/4	1/3	0/16	1/14	0/11
GastroenteritisInfections and infestations	0/4	1/3	0/16	0/14	0/11
NauseaGastrointestinal disorders	1/4	1/3	0/16	0/14	2/11
PyrexiaGeneral disorders	0/4	1/3	0/16	0/14	0/11
LeukopeniaBlood and lymphatic system disorders	0/4	1/3	0/16	0/14	0/11
DiarrhoeaGastrointestinal disorders	1/4	0/3	0/16	0/14	0/11
HeadacheNervous system disorders	1/4	0/3	3/16	3/14	0/11
Influenza like illnessGeneral disorders	0/4	0/3	1/16	3/14	1/11
Gastroenteritis viralInfections and infestations	0/4	0/3	3/16	0/14	0/11

Baseline characteristics

Full analysis population included all participants enrolled into the study and received at least 1 dose of bempedoic acid.

Age, Continuous
Age, Continuous(years)	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 3 Bempedoic Acid (> 60 Kg)	Total
Mean	7.5 ± 1.29	12.4 ± 2.39	14.8 ± 1.99	12.6 ± 3.10

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 3 Bempedoic Acid (> 60 Kg)	Total
Female	2	8	7	17
Male	2	8	4	14

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 3 Bempedoic Acid (> 60 Kg)	Total
Hispanic or Latino	0	0	1	1
Not Hispanic or Latino	4	16	10	30
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 Bempedoic Acid (16 to <30 Kg)	Cohort 2 Bempedoic Acid (30 to 60 Kg)	Cohort 3 Bempedoic Acid (> 60 Kg)	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	2	2
White	4	15	9	28
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Study locations

24 sites

Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
Providere Research Inc
West Covina, California 91790, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida 33434, United States
Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research
St Louis, Missouri 63110, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229, United States
Cardiology Care for Children
Lancaster, Pennsylvania 17601, United States
University of Utah and Primary Children's Hospital
Salt Lake City, Utah 84113, United States
University of Alberta Hospital - Stollery Children's Hospital
Edmonton, Alberta T6G 2B7, Canada
McMaster University Medical Center
Hamilton, Ontario L8N 3Z5, Canada
Ecogene-21
Chicoutimi, Quebec G7H 5H6, Canada
Rigshospitalet
Copenhagen, 2100, Denmark
Viborg Regional Hospital
Viborg, Denmark
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, Germany
Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, Germany
Amsterdam UMC - Locatie AMC
Amsterdam, 1105 AZ, Netherlands
Erasmus MC
Rotterdam, 3015 G, Netherlands
Hospital Abente y Lago
A Coruña, Galicia 15001, Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Barcelona, 8208, Spain
Hospital Sant Joan de Deu
Barcelona, 8950, Spain
Hospital Universitario de Jerez de la Frontera
Cadiz, 11407, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain

References and documents

Study documents

Study protocol · Jan 29, 2025
Statistical analysis plan · Jun 6, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The Investigator must ensure that the participant's confidentiality is maintained. The names and identities of all research participants will be kept in strict confidence and will not appear on eCRFs or other records that are provided to or retained by the Sponsor (or designee). If a participant's name appears on any document, it must be redacted and replaced with the participant identifier before a copy of the document is supplied to the Sponsor (or designee). The ICF must include appropriate statements explaining that participant data will be confidential and the actions that will be taken to ensure participant confidentiality. Any other confidentiality requirements specified by the site, IRB or IEC, or national or local regulations will be adhered to and detailed appropriately in the ICF.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05694260
Lead sponsor: Esperion Therapeutics, Inc.
Responsible party: Sponsor
First posted: Jan 23, 2023
Start date: Jan 12, 2023
Primary completion: Jun 4, 2025
Completion: Jun 4, 2025
Results posted: Jul 17, 2026
Last update: Jul 17, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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