Last Update: Jul 10, 2026
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
ClinicalTrials.gov Identifier:
NCT07626281
Novartis Reference Number:CKJX839A12107
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. This is a randomized, single-dose, open-label, parallel-group, study to evaluate the PK, safety, and tolerability of inclisiran 284 mg. The study drug will be administered as a single SC injection to the abdomen administered as 2 different formulations (the marketed formulation and a test formulation containing PS80). Approximately 152 adult participants (76 per formulation) with elevated serum LDL-C, but otherwise healthy, are planned to be enrolled.

The duration of the study for each participant will be approximately 118 days including the screening, up to 28 days, baseline period, and treatment period of 90 days.

Inclisiran Formulation
Phase1
Recruiting
120
Jun 09, 2026
Dec 21, 2026
All
18 Years - 60 Years (Adult)

Interventions

Drug

Currently marketed inclisiran formulation

Inclisiran 284 mg
Drug

Inclisiran formulation containing PS80

Inclisiran 284 mg

Eligibility Criteria

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

Lenexa Research Unit

Recruiting

Lenexa,Kansas,66219,United States

Cardiovasular Renal Metabolism

Recruiting

San Antonio,Texas,78232,United States

Salt Lake City Research Unit

Recruiting

Salt Lake City,Utah,84124,United States

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