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](https://clinicaltrials.gov/ct2/show/NCT07626281) Novartis Reference Number:CKJX839A12107 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 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. Condition Inclisiran Formulation Phase Phase1 Overall Status Recruiting Number of Participants120 Start Date Jun 09, 2026 Completion Date Dec 21, 2026 Gender All Age(s) 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 United States #### 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 ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: