Recruiting
Phase 1

Inclisiran vs. PS80

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07626281

Conditions

Inclisiran Formulation

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Inclisiran formulation containing PS80

Currently marketed inclisiran formulation

Study Details

Brief 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.

Conditions

Inclisiran Formulation

Study ID

NCT07626281

Start date

Jun 9, 2026

Status verified date

Jul, 2026

Completion date

Dec 21, 2026

Anticipated

Primary completion date

Dec 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (inclisiran - currently marketed formulation)

Inclisiran 284 mg × 1 single dose on Day 1

experimental: Arm B (inclisiran - formulation containing PS80)

Inclisiran 284 mg × 1 single dose on Day 1

Interventions

Inclisiran formulation containing PS80

Inclisiran 284 mg

Currently marketed inclisiran formulation

Inclisiran 284 mg

Primary outcome measure

  • Primary plasma PK parameters: Cmax [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Primary plasma PK parameters: AUClast [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Primary plasma PK parameters: AUCinf [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Additional PK parameters: AUC0-24hr [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Additional PK parameters: Tmax [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Additional PK parameters: T1/2 [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Additional PK parameters: CL/F [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]
  • Additional PK parameters: Vz/F [ Time Frame: Day 1, Day 2, Day 3 and Day 4 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Locations

Lenexa Research Unit

Recruiting

Lenexa, Kansas, United States, 66219

Cardiovasular Renal Metabolism

Recruiting

San Antonio, Texas, United States, 78232

Salt Lake City Research Unit

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Inclisiran containing polysorbate 80
  • healthy male and female participants
  • safety
  • tolerability
  • pharmacokinetics
  • pharmacodynamics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-10.