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A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)

Primary Purpose

Hypercholesterolemia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bempedoic acid
Sponsored by
Esperion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Pediatric, HeFH, LDL-cholesterol, ETC-1002, Adenosine triphosphate citrate lyase

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent and assent (where applicable) Aged 6-17 years old Diagnosis of HeFH (heterozygous familial hypercholesterolemia) Treatment with approved stable lipid modifying therapies Fasting LDL-C greater than or equal to 130 mg/dL (3.4 mmol/L) Exclusion Criteria: Diagnosis of HoFH (homozygous familial hypercholesterolemia) or compound HeFH Fasting Triglyceride greater than or equal to 400 mg/dL (4.5 mmol/L) Type 1 or Type 2 diabetes or newly diagnosed impaired glucose tolerance Women/girls who are pregnant or breastfeeding

Sites / Locations

  • Smidt Heart Institute at Cedars-SinaiRecruiting
  • Continental Clinical SolutionsRecruiting
  • Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research.Recruiting
  • Wake Forest University Health SciencesRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • University of Utah and Primary Children's HospitalRecruiting
  • University of Alberta Hospital - Stollery Children's HospitalRecruiting
  • McMaster University Medical CenterRecruiting
  • The Hospital for Sick Children (SickKids)Recruiting
  • Ecogene-21Recruiting
  • RigshospitaletRecruiting
  • Kinder- und Jugendkrankenhaus AUF DER BULTRecruiting
  • Amsterdam UMC - Locatie AMCRecruiting
  • Erasmus MCRecruiting
  • Corporacio Sanitaria Parc Tauli - Hospital de SabadellRecruiting
  • Hospital Sant Joan de DeuRecruiting
  • Hospital Universitario de Jerez de la FronteraRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Abente y LagoRecruiting
  • Hospital Universitario Ramon y CajalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Patients at 16 to <30 kg body weight at screening receiving once daily 60 mg bempedoic acid for 8 weeks followed by 90 mg bempedoic acid for 8 weeks.

Patients 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.

Patients at greater than 60 kg body weight at screening receiving once daily 180 mg bempedoic acid for 8 weeks.

Outcomes

Primary Outcome Measures

Observed pharmacokinetics - trough plasma concentration of ETC-1002
observed trough plasma concentration of ETC-1002
Model-based pharmacokinetics - AUC, ss
Model-based area under the plasma concentration-time curve (AUC,ss)
Model-based pharmacokinetics - Cavg, ss
Model-based average plasma concentration (Cavg,ss)
Model-based pharmacokinetics - Cmax, ss
Model-based maximum plasma concentration (Cmax,ss)

Secondary Outcome Measures

Exposure/LDL-C response relationship
ETC-1002 dose and exposure/LDL-C-lowering response relationship
Percent change from baseline in LDL-C
Percent change from baseline to Week 8 in LDL-C
Adverse Events
Observed adverse events

Full Information

First Posted
January 12, 2023
Last Updated
August 8, 2023
Sponsor
Esperion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05694260
Brief Title
A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing
Acronym
CLEAR Path 1
Official Title
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in Pediatric Patients (6 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
March 24, 2024 (Anticipated)
Study Completion Date
May 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.
Detailed Description
Dose-selection based on body weight will be determined for use in pediatric clinical development

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Pediatric, HeFH, LDL-cholesterol, ETC-1002, Adenosine triphosphate citrate lyase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patients at 16 to <30 kg body weight at screening receiving once daily 60 mg bempedoic acid for 8 weeks followed by 90 mg bempedoic acid for 8 weeks.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Patients 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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Patients at greater than 60 kg body weight at screening receiving once daily 180 mg bempedoic acid for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Bempedoic acid
Other Intervention Name(s)
ETC-1002
Intervention Description
Once daily oral dosing with oral tablets or oral suspension.
Primary Outcome Measure Information:
Title
Observed pharmacokinetics - trough plasma concentration of ETC-1002
Description
observed trough plasma concentration of ETC-1002
Time Frame
8 weeks of steady-state dosing
Title
Model-based pharmacokinetics - AUC, ss
Description
Model-based area under the plasma concentration-time curve (AUC,ss)
Time Frame
8 weeks of steady-state dosing
Title
Model-based pharmacokinetics - Cavg, ss
Description
Model-based average plasma concentration (Cavg,ss)
Time Frame
8 weeks of steady-state dosing
Title
Model-based pharmacokinetics - Cmax, ss
Description
Model-based maximum plasma concentration (Cmax,ss)
Time Frame
8 weeks of steady-state dosing
Secondary Outcome Measure Information:
Title
Exposure/LDL-C response relationship
Description
ETC-1002 dose and exposure/LDL-C-lowering response relationship
Time Frame
8 weeks of steady-state dosing
Title
Percent change from baseline in LDL-C
Description
Percent change from baseline to Week 8 in LDL-C
Time Frame
8 weeks of steady-state dosing
Title
Adverse Events
Description
Observed adverse events
Time Frame
8 weeks of steady-state dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent and assent (where applicable) Aged 6-17 years old Diagnosis of HeFH (heterozygous familial hypercholesterolemia) Treatment with approved stable lipid modifying therapies Fasting LDL-C greater than or equal to 130 mg/dL (3.4 mmol/L) Exclusion Criteria: Diagnosis of HoFH (homozygous familial hypercholesterolemia) or compound HeFH Fasting Triglyceride greater than or equal to 400 mg/dL (4.5 mmol/L) Type 1 or Type 2 diabetes or newly diagnosed impaired glucose tolerance Women/girls who are pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esperion Medical Information
Phone
833-377-7633
Email
medinfo@esperion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey C Hanselman, MS
Organizational Affiliation
Esperion Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Smidt Heart Institute at Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 807
Email
medinfo@esperion.com
Facility Name
Continental Clinical Solutions
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 808
Email
medinfo@esperion.com
Facility Name
Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 801
Email
medinfo@esperion.com
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 803
Email
medinfo@esperion.com
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 804
Email
medinfo@esperion.com
Facility Name
University of Utah and Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 806
Email
medinfo@esperion.com
Facility Name
University of Alberta Hospital - Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 102
Email
medinfo@esperion.com
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 101
Email
medinfo@esperion.com
Facility Name
The Hospital for Sick Children (SickKids)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 104
Email
medinfo@esperion.com
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 103
Email
medinfo@esperion.com
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 201
Email
medinfo@esperion.com
Facility Name
Kinder- und Jugendkrankenhaus AUF DER BULT
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 301
Email
medinfo@esperion.com
Facility Name
Amsterdam UMC - Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 401
Email
medinfo@esperion.com
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 G
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 402
Email
medinfo@esperion.com
Facility Name
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
City
Barcelona
ZIP/Postal Code
8208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 602
Email
medinfo@esperion.com
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
ZIP/Postal Code
8950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 606
Email
medinfo@esperion.com
Facility Name
Hospital Universitario de Jerez de la Frontera
City
Cadiz
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 603
Email
medinfo@esperion.com
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 607
Email
medinfo@esperion.com
Facility Name
Hospital Abente y Lago
City
La Coruña
ZIP/Postal Code
15001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 601
Email
medinfo@esperion.com
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Site Coordinator 608
Email
medinfo@esperion.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The Investigator must ensure that the patient's confidentiality is maintained. The names and identities of all research patients 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 patient's name appears on any document, it must be redacted and replaced with the patient identifier before a copy of the document is supplied to the Sponsor (or designee). The ICF must include appropriate statements explaining that patient data will be confidential and the actions that will be taken to ensure patient 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.

Learn more about this trial

A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing

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