The primary purpose of the study is to evaluate the efficacy of olezarsen administered by subcutaneous injection to pediatric participants with FCS.
Parental or legally authorized representative consent must be obtained, and the participants must provide age-appropriate or cognition-appropriate assent, as determined by the Investigator. The parent or legal guardian must be able to understand and comply with the study visit schedule and all other study procedures.
Must be able to comply with all study procedures.
Age 12 to less than 18 years at the time of informed consent/assent (Cohort 1); age 2 to less than 12 years at time of informed consent/assent (Cohort 2).
Willing to fast for at least 10 hours before visits requiring fasted blood sampling.
Newly diagnosed within 12 weeks prior to screening or during the screening period.
Hemoglobin A1c (HbA1c) ≥9.5% at screening.
Change in basal insulin regimen >20% within 3 months prior to screening or during the screening period.
Type 1 diabetes.
Parallel
Olezarsen
DrugOlezarsen will be administered by subcutaneous injection.
Percent Change from Baseline in Fasting Triglycerides (TG)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Including Independently Adjudicated Events of Pancreatitis, and Withdrawals due to Adverse Events (AEs)
Change From Baseline in Vital Sign Parameter - Heart Rate (Beats per Minute)
Change From Baseline in Vital Sign Parameter - Blood Pressure (Systolic and Diastolic, mmHg)
Change From Baseline in Vital Sign Parameter - Oxygen Saturation (%)
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