deltatrials
Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06597006

Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia (ORION-19)

Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Children (2 to Less Than 12 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol

Sponsor: Novartis Pharmaceuticals

Updated 10 times since 2024 Last updated: Feb 18, 2026 Started: Feb 28, 2025 Primary completion: Mar 23, 2028 Completion: Apr 15, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Familial Hypercholesterolemia - Homozygous and is currently actively recruiting participants. Novartis Pharmaceuticals leads this study, which shows 10 recorded versions since 2025 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Apr 2025 · 4 months · monthly snapshotNot Yet Recruiting~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshotRecruiting~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshotRecruiting~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshotRecruiting~Nov 2025 – ~Jan 2026 · 2 months · monthly snapshotRecruiting~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshotRecruiting

Change History

10 versions recorded
  1. Feb 2026 — Present [monthly]

    Recruiting PHASE3

  2. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE3

  3. Nov 2025 — Jan 2026 [monthly]

    Recruiting PHASE3

  4. Sep 2025 — Nov 2025 [monthly]

    Recruiting PHASE3

  5. Jul 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

Show 5 earlier versions
  1. May 2025 — Jul 2025 [monthly]

    Recruiting PHASE3

  2. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  3. Dec 2024 — Apr 2025 [monthly]

    Not Yet Recruiting PHASE3

  4. Nov 2024 — Dec 2024 [monthly]

    Not Yet Recruiting PHASE3

  5. Oct 2024 — Nov 2024 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .