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Bempedoic Acid for High Cholesterol in Children (CLEAR Path 1 Trial)
Los Angeles, CA
Phase 2
Recruiting
Research Sponsored by Esperion Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 6-17 years old
Treatment with approved stable lipid modifying therapies
Must not have
Type 1 or Type 2 diabetes or newly diagnosed impaired glucose tolerance
Women/girls who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks of steady-state dosing
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a medicine for kids 6-17 with hereditary high cholesterol to see if it's safe, how well it works, and how their bodies process it.
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Who is the study for?
This trial is for children aged 6-17 with HeFH (a genetic cholesterol disorder) who have high LDL cholesterol levels despite taking other lipid-modifying medications. They must not have diabetes, extremely high triglycerides, or be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the effects of bempedoic acid, a medication intended to lower cholesterol levels in pediatric patients with HeFH. It's given once daily and researchers will monitor how it's processed by the body and its impact on cholesterol.See study design
What are the potential side effects?
While specific side effects for this age group are being studied, bempedoic acid in adults can cause symptoms like muscle pain, increased uric acid leading to gout, and respiratory issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 17 years old.
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I am on a stable treatment for my cholesterol.
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I have been diagnosed with HeFH.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes or my blood sugar levels are higher than normal.
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I am currently pregnant or breastfeeding.
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I have been diagnosed with a severe form of inherited high cholesterol.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks of steady-state dosing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks of steady-state dosing
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Exposure/LDL-C response relationship
Side effects data
From 2018 Phase 3 trial • 269 Patients • NCT030010768%
Blood uric acid increase
4%
Liver function test increased
4%
Headache
3%
Urinary tract infection
3%
Muscle spasms
3%
Sinusitis
3%
Nausea
2%
Glomerular filtration rate decreased
2%
Myalgia
2%
Nasopharyngitis
1%
Bronchitis
1%
Intestinal obstruction
1%
Diabetes mellitus
1%
Osteoarthritis
1%
Syncope
1%
Hepatic cancer
1%
Dysuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Bempedoic Acid
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Participants at greater than 60 kg body weight at screening receiving once daily 180 mg bempedoic acid for 8 weeks.
Group II: Cohort 2Experimental Treatment1 Intervention
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.
Group III: Cohort 1Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempedoic acid
2016
Completed Phase 3
~270
Find a Location
Closest Location:Cincinnati Children's Hospital Medical Center· Cincinnati, OH· 97 miles
Who is running the clinical trial?
Esperion Therapeutics, Inc.Lead Sponsor
25 Previous Clinical Trials
21,864 Total Patients Enrolled
Michael Louie, MDStudy DirectorEsperion Therapeutics, Inc.
2 Previous Clinical Trials
13,990 Total Patients Enrolled
Jeffrey C Hanselman, MSStudy DirectorEsperion Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your "bad" cholesterol (LDL-C) level is higher than 130 mg/dL after not eating for a while.I have diabetes or my blood sugar levels are higher than normal.I am between 6 and 17 years old.Your fasting triglyceride level is 400 mg/dL (4.5 mmol/L) or higher.I am currently pregnant or breastfeeding.I am on a stable treatment for my cholesterol.I have been diagnosed with a severe form of inherited high cholesterol.I have been diagnosed with HeFH.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 1
- Group 3: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.