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)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT05694260
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Jan 23, 2023
Start date
Jan 12, 2023
Status verified
Jul 2026
Primary completion
Jun 4, 2025
Completion
Jun 4, 2025

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.
  • Experimental: Cohort 3
    Participants at greater than 60 kg body weight at screening receiving once daily 180 mg bempedoic acid for 8 weeks.

Primary Outcome Measure

Observed Trough Plasma Concentration of ETC-1002 Following 8 Weeks of Steady State Dosing of Bempedoic Acid [ Time Frame: Week 8 pre-dose ]

Locations (8)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Providere Research IncWest CovinaCalifornia91790-
Excel Medical Clinical Trials, LLCBoca RatonFlorida33434-
Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid ResearchSt LouisMissouri63110-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Cardiology Care for ChildrenLancasterPennsylvania17601-
University of Utah and Primary Children's HospitalSalt Lake CityUtah84113-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAProvidere Research Inc· West Covina, CAExcel Medical Clinical Trials, LLC· Boca Raton, FLWashington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research· St Louis, MOWake Forest University Health Sciences· Winston-Salem, NCCincinnati Children's Hospital Medical Center· Cincinnati, OH

Related Studies