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Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 3 of 8 entries Enrollment increased: 120 → 152 participants · Trial sites expanded: 3 → 6 locations · Eligibility criteria expanded, about 4 words Show 3 more changesShow less
    • Enrollment increased: 120 → 152 participants
    • Trial sites expanded: 3 → 6 locations
    • Eligibility criteria expanded, about 4 words
  2. Recruitment opened Trial sites expanded: 0 → 3 locations · Start date changed from estimate of Jun 15, 2026 to Jun 9, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Jun 15, 2026 to Jun 9, 2026
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
555 trials monitored
See 31 trials at risk
The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a single 284 mg subcutaneous (SC) administration.
Trial Details
NCT Number NCT07626281
Lead Sponsor Novartis Pharmaceuticals
Conditions Inclisiran Formulation
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov