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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

A Randomized, Open-label, Single-dose, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclisiran Containing Polysorbate 80 Versus Inclisiran Alone in Participants With Elevated Low-density Lipoprotein Cholesterol

Who can join

Ages 18 to 60 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Healthy male and female (non-childbearing potential) participants between 18 and 60 years of age (inclusive) with fasting serum LDL-C between 100 and 189 mg/dL (2.6 to 4.89 mmol/L) and fasting triglyceride \<400 mg/dL (\<4.52 mmol/L) that are not on statin or any other lipid lowering therapy.
* Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening with a body weight of at least 50 kg.

Exclusion Criteria:

* Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded.
* Historical or current use of any statin (i.e. study participants must be statin naive), other oral LDL-C-lowering medication or supplements that in investigators' judgment may affect serum LDL-C levels.

Other protocol inclusion/exclusion criteria may apply

About the study

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.

What is being tested

• Inclisiran formulation containing PS80 (drug)
• Currently marketed inclisiran formulation (drug)

Sponsor: Novartis Pharmaceuticals · Participants: 120 · Started: Jun 9, 2026

Contact the study team

• Novartis Pharmaceuticals · Phone: 1-888-669-6682

Official record on ClinicalTrials.gov — NCT07626281

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.