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Bempedoic Acid for High Cholesterol in Children (CLEAR Path 1 Trial)

Q: Does this experiment in medicine accept participants older than twenty years?

Per the specified prerequisites, minors aged 6 to 17 are eligible applicants for this trial.

Q: Is it possible for me to sign up for this particular experiment?

This clinical trial, which is open to 54 individuals, requires high <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a> and an age range of 6-17 years old.

Q: Has the FDA sanctioned Cohort 1?

Data gathered by the Power team assesses Cohort 1's safety to be a 2, as there is evidence of its security but no verifiable proof yet of efficacy.

Q: Are individuals still being accepted to take part in this experiment?

Affirmative. According to clinicaltrials.gov, this trial was initially submitted on December 1st 2023 and is still actively recruiting participants. Roughly 54 individuals need to be accepted from one medical centre.

Q: What is the enrolment capacity of this clinical trial?

That is accurate. According to the clinicaltrials.gov record, this trial is presently seeking for participants and was initially posted on December 1st 2023 before being updated recently on the same date. The research necessitates 54 volunteers from a single medical centre.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks of steady-state dosing

Awards & highlights

CLEAR Path 1 Trial 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.

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.

CLEAR Path 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 17 years old.

Select...

I am on a stable treatment for my cholesterol.

Select...

I have been diagnosed with HeFH.

CLEAR Path 1 Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks of steady-state dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Model-based pharmacokinetics - AUC, ss

Model-based pharmacokinetics - Cavg, ss

Model-based pharmacokinetics - Cmax, ss

+1 more

Secondary outcome measures

Adverse Events

Exposure/LDL-C response relationship

Percent change from baseline in LDL-C

Side effects data

From 2018 Phase 3 trial • 269 Patients • NCT03001076

Blood uric acid increase

Headache

Liver function test increased

Muscle spasms

Nausea

Urinary tract infection

Sinusitis

Myalgia

Nasopharyngitis

Glomerular filtration rate decreased

Intestinal obstruction

Hepatic cancer

Syncope

Dysuria

Bronchitis

Osteoarthritis

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Bempedoic Acid

CLEAR Path 1 Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

Patients 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

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.

Group III: Cohort 1Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bempedoic acid

2016

Completed Phase 3

~270

0 / 3Eligibility criteria met

Find a Location

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

Bempedoic acid (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05694260 — Phase 2

High Cholesterol Research Study Groups: Cohort 3, Cohort 1, Cohort 2

High Cholesterol Clinical Trial 2023: Bempedoic acid Highlights & Side Effects. Trial Name: NCT05694260 — Phase 2

Bempedoic acid (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05694260 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment in medicine accept participants older than twenty years?

"Per the specified prerequisites, minors aged 6 to 17 are eligible applicants for this trial."

Answered by AI

Is it possible for me to sign up for this particular experiment?

"This clinical trial, which is open to 54 individuals, requires high cholesterol and an age range of 6-17 years old."

Answered by AI

Has the FDA sanctioned Cohort 1?

"Data gathered by the Power team assesses Cohort 1's safety to be a 2, as there is evidence of its security but no verifiable proof yet of efficacy."

Answered by AI

Are individuals still being accepted to take part in this experiment?

"Affirmative. According to clinicaltrials.gov, this trial was initially submitted on December 1st 2023 and is still actively recruiting participants. Roughly 54 individuals need to be accepted from one medical centre."

Answered by AI

What is the enrolment capacity of this clinical trial?

"That is accurate. According to the clinicaltrials.gov record, this trial is presently seeking for participants and was initially posted on December 1st 2023 before being updated recently on the same date. The research necessitates 54 volunteers from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05694260.

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