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

Recruiting now · Phase 1

Conditions studied: Inclisiran Formulation

In brief

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.

Key facts

Study ID: NCT07626281
Run by: Novartis Pharmaceuticals
People needed: 120
Starts: 2026-06-09
Expected to finish: 2026-12-21
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Lenexa Research Unit — Lenexa, Kansas, United States (enrolling)
Cardiovasular Renal Metabolism — San Antonio, Texas, United States (enrolling)
Salt Lake City Research Unit — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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