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Inclisiran Formulations Study

This study is looking at two different versions of inclisiran, a medication used to lower cholesterol. One is the inclisiran you can get now, and the other is a new version that includes polysorbate 80 (PS80). Researchers want to see if the new version is safe, how well your body handles it, and how it moves through your system compared to the current inclisiran. You might be able to join if you are a healthy male or a female who cannot get pregnant, between 18 and 60 years old, with slightly high LDL-C (bad cholesterol) and normal triglycerides, and not currently taking cholesterol-lowering medicines. The study will measure how much inclisiran is in your blood at different times to understand how it works. The study status is currently unclear.

Study design
This is an open-label study, meaning you and the study team will know which inclisiran formulation you receive. It will involve about 152 healthy adult participants with elevated LDL-C.
What's involved
You will receive a single injection of either inclisiran formulation under your skin. Your total participation in the study will last about 118 days, including screening, a baseline period, and a 90-day treatment period.
Compensation
Not stated in the trial record.
Follow-up
Your blood will be tested to measure inclisiran levels on Day 1, Day 2, Day 3, and Day 4 after the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07626281

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

Recruiting
PHASE1Ages 18–60InterventionalTreatment
Novartis Pharmaceuticals
~120 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Inclisiran formulation containing PS80Currently marketed inclisiran formulation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary plasma PK parameters: Cmax
Measured over Day 1, Day 2, Day 3 and Day 4
+7 more outcomes measured

Conditions

Inclisiran Formulation

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Healthy Volunteers

NCT07626281

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cardiovasular Renal Metabolism

    San Antonio, Texasno site contact published

    Recruiting

  • Lenexa Research Unit

    Lenexa, Kansasno site contact published

    Recruiting

  • Salt Lake City Research Unit

    Salt Lake City, Utahno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary plasma PK parameters: CmaxDay 1, Day 2, Day 3 and Day 4

    Cmax = maximum observed plasma concentration

  • Primary plasma PK parameters: AUClastDay 1, Day 2, Day 3 and Day 4

    AUClast = AUC from time zero to the last measurable concentration sampling time

  • Primary plasma PK parameters: AUCinfDay 1, Day 2, Day 3 and Day 4

    AUCinf = AUC from time zero to infinity

  • Additional PK parameters: AUC0-24hrDay 1, Day 2, Day 3 and Day 4

    AUC0-24hr = AUC from time zero to 24 hours

  • Additional PK parameters: TmaxDay 1, Day 2, Day 3 and Day 4

    Tmax = time to reach maximum plasma concentration

  • Additional PK parameters: T1/2Day 1, Day 2, Day 3 and Day 4

    T1/2 = elimination half-life

  • Additional PK parameters: CL/FDay 1, Day 2, Day 3 and Day 4

    CL/F = total body clearance

  • Additional PK parameters: Vz/FDay 1, Day 2, Day 3 and Day 4

    Vz/F = apparent volume of distribution