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Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia (SPRUCE)
EU CTIS ID: 2025-523662-24-00
What this study is testing
To demonstrate reduction of LDL-C with zodasiran in adolescent participants with HoFH
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adolescents 12 to <18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study
- 2. Body weight ≥35 kilograms (kg) at screening
- 3. HoFH based on a supportive genetic test (from a source-verifiable medical record or based on screening genotype) or clinical diagnosis
- 4. Screening LDL-C ≥116 mg/dL (3 mmol/L)
- 5. Screening hemoglobin A1c (HbA1c) ≤9.5%
- 6. Total bilirubin <2×upper limit of normal (ULN), unless in previously confirmed cases of Gilbert’s syndrome
You likely can't join if
- 1. Use of a hepatocyte-targeted siRNA within 365 days before Day 1 (except inclisiran, which is permitted; administration of inclisiran and study drug must be separated by at least 4 weeks)
- 2. Use of an antisense oligonucleotide molecule within 3 months before Day 1
- 3. Use of evinacumab within 3 months before Day 1
- 4. Use of systemic corticosteroids (unless used as replacement therapy for pituitary/adrenal disease with a stable regimen)
- 5. NOTE: Additional inclusion/exclusion criteria may apply per protocol
See the full eligibility criteria
- 1. Adolescents 12 to <18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study
- 2. Body weight ≥35 kilograms (kg) at screening
- 3. HoFH based on a supportive genetic test (from a source-verifiable medical record or based on screening genotype) or clinical diagnosis
- 4. Screening LDL-C ≥116 mg/dL (3 mmol/L)
- 5. Screening hemoglobin A1c (HbA1c) ≤9.5%
- 6. Total bilirubin <2×upper limit of normal (ULN), unless in previously confirmed cases of Gilbert’s syndrome
- 7. Alanine aminotransferase or aspartate aminotransferase <3×ULN
- 8. NOTE: Additional inclusion/exclusion criteria may apply per protocol
- 1. Use of a hepatocyte-targeted siRNA within 365 days before Day 1 (except inclisiran, which is permitted; administration of inclisiran and study drug must be separated by at least 4 weeks)
- 2. Use of an antisense oligonucleotide molecule within 3 months before Day 1
- 3. Use of evinacumab within 3 months before Day 1
- 4. Use of systemic corticosteroids (unless used as replacement therapy for pituitary/adrenal disease with a stable regimen)
- 5. NOTE: Additional inclusion/exclusion criteria may apply per protocol
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.