The CLEAR Path 1 study is a clinical research study for children and teens who have heterozygous familial hypercholesterolemia (HeFH). The study will test a new investigational medication to learn if it can help lower LDL cholesterol.
Study participants may be able to join the study if they meet the following requirements:
- 6 to 17 years old
- High LDL-Cholesterol and/or confirmed diagnosis of HeFH
- Currently taking a statin or not able to take a statin due to intolerance
Other study requirements will apply
Participants will be in the CLEAR Path 1 study for either 3 or 6 months and can expect the following:
1. Review & Sign
A parent or legal guardian must review and sign the Informed Consent Form before a child can participate in the HeFH clinical trial.
2. Complete Screening
Participants will undergo study health assessments to confirm if they qualify for the study. These will include a physical exam, blood and urine tests, and an optional genetic test.
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3. Treatment Period
If they qualify, participants will take the study medication each day for either 2 or 4 months. The study doctor will tell participants and their parent(s) or legal guardian(s) how long to take the study medication. During this time, participants will complete either 5 or 9 study visits, which will include more assessments like those from Screening. Some visits will occur at the study clinic and others via phone.
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4. Follow-up Period
About 1 month after participants stop taking the study medication, they will visit the study clinic for follow-up assessments.
Participation in a clinical study is voluntary. You can ask any questions you may have and may leave the CLEAR Path 1 study at any time, for any reason.
