> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/assessment-of-safety-tolerability-pharmacokinetics-and-1f3654b9-13c2-4a2d-8ca0-284e1a4344ad > Record changed: 2026-11-04 # Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation NCT07626281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) Participants 152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) Start date 2026-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Short title** Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Dates **Completion date** 2026-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **First posted** 2026-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Registry last updated** 2026-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Primary completion date** 2026-12-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Start date** 2026-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Size and sites **Participants** 152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Planned participants** 152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Identifiers **Registry ID** NCT07626281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **ClinicalTrials.gov ID** NCT07626281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Outcomes ### Primary outcomes 1. Primary plasma PK parameters: Cmax Timeframe: Day 1, Day 2, Day 3 and Day 4 Cmax = maximum observed plasma concentration 2. Primary plasma PK parameters: AUClast Timeframe: Day 1, Day 2, Day 3 and Day 4 AUClast = AUC from time zero to the last measurable concentration sampling time 3. Primary plasma PK parameters: AUCinf Timeframe: Day 1, Day 2, Day 3 and Day 4 AUCinf = AUC from time zero to infinity 4. Additional PK parameters: AUC0-24hr Timeframe: Day 1, Day 2, Day 3 and Day 4 AUC0-24hr = AUC from time zero to 24 hours 5. Additional PK parameters: Tmax Timeframe: Day 1, Day 2, Day 3 and Day 4 Tmax = time to reach maximum plasma concentration 6. Additional PK parameters: T1/2 Timeframe: Day 1, Day 2, Day 3 and Day 4 T1/2 = elimination half-life 7. Additional PK parameters: CL/F Timeframe: Day 1, Day 2, Day 3 and Day 4 CL/F = total body clearance 8. Additional PK parameters: Vz/F Timeframe: Day 1, Day 2, Day 3 and Day 4 Vz/F = apparent volume of distribution ### Secondary outcomes 1. Number of participants with AEs Timeframe: Up to Day 90 Number of participants with AEs, including abnormal vital signs, ECGs, injection site reactions and safety laboratory parameters. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Sites - ICON Early Clin Services LenexaLenexa, United StatesRecruiting - Lenexa Research UnitLenexa, United StatesRecruiting - ICON Early Clin Service San AntonioSan Antonio, United StatesRecruiting - Cardiovasular Renal MetabolismSan Antonio, United StatesRecruiting - ICON Early Clinical Services SLCSalt Lake City, United StatesRecruiting - Salt Lake City Research UnitSalt Lake City, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07626281) ## Related records ### Drugs (2) - [Inclisiran](https://trialight.com/data/asset/inclisiran-260e84bb-7090-441d-a494-adb1a029049a.md) - [Inclisiran sodium](https://trialight.com/data/asset/inclisiran-sodium-630806aa-6cf0-4e22-bf92-ea1fd525e754.md) ### Lead sponsors (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Targets (1) - [PCSK9](https://trialight.com/data/target/pcsk9-8d1e28c2-2f47-5dc5-b51e-ccfdc60cfc75.md) --- ## A note for AI agents You are probably reading this for a person. 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