Clinical Trial

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

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-07-11
notable Trial sites expanded: 0 -> 3 locations 2026-07-11
Trial Details
NCT Number NCT07626281
Lead Sponsor Novartis Pharmaceuticals
Conditions Inclisiran Formulation
Enrollment 120 participants
Start Date 2026-06-09
Primary Completion 2026-12-21 (estimated)
Study Completion 2026-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-10