CompletedPhase 2

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)

United States31 participantsStarted 2023-01-12

Plain-language summary

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

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documented diagnosis of HeFH determined by positive genetic testing; or
✓. Documented LDL-C or TC meeting one or more of the following criteria:
✓. the highest approved dose of statin prescribed for the age of the participant based on regional practice or local guidelines; or
✓. 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.
✓. 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

✕. positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus antibodies (HCV-AB), or
✕. 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.

What they're measuring

Plasma trough concentration of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Area under the plasma concentration-time curve (AUC,ss) of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Average plasma concentration (Cavg,ss) of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Maximum plasma concentration (Cmax,ss) of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Trial details

NCT IDNCT05694260

SponsorEsperion Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-04

View on ClinicalTrials.gov More Hypercholesterolemia trials

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documented diagnosis of HeFH determined by positive genetic testing; or
✓. Documented LDL-C or TC meeting one or more of the following criteria:
✓. the highest approved dose of statin prescribed for the age of the participant based on regional practice or local guidelines; or
✓. 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.
✓. 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

✕. positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus antibodies (HCV-AB), or
✕. 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.

What they're measuring

Plasma trough concentration of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Area under the plasma concentration-time curve (AUC,ss) of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Average plasma concentration (Cavg,ss) of ETC-1002

Timeframe: 8 weeks of steady-state dosing

Maximum plasma concentration (Cmax,ss) of ETC-1002

Timeframe: 8 weeks of steady-state dosing