Safety and PK/PD of a new inclisiran formulation with polysorbate 80 vs the marketed version in healthy adults
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
Run by Novartis · NCT07626281 · Data updated 2026-11-12
This study tests a new inclisiran formulation containing polysorbate 80 to see if it is as safe and tolerable as the current version after a single injection in healthy adults with elevated LDL-C.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 152 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 6 sites (Lenexa, Kansas and 5 other locations) |
| Status | Recruiting |
| Started | June 9, 2026 |
| Main results expected | December 21, 2026 |
| Study ends | December 21, 2026 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07626281 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–60 with LDL-C 100–189 mg/dL, not on lipid-lowering therapy, BMI 18–35 kg/m2, and weighing at least 50 kg.
✕Probably not a fit
Participants with familial hypercholesterolemia, current or recent statin use, or other lipid-lowering therapies are unlikely to benefit from this specific comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label, parallel-group Phase 1 study comparing a new inclisiran formulation containing polysorbate 80 to the currently marketed formulation after a single subcutaneous dose of 284 mg. The trial evaluates safety, tolerability, pharmacokinetics, and pharmacodynamics in about 152 healthy adults with elevated LDL-C who are not on lipid-lowering therapy. Participants will be followed for roughly 118 days, including screening, a treatment period of 90 days, and follow-up. Enrollment includes adults aged 18–60 with BMI 18–35 kg/m2 and LDL-C 100–189 mg/dL, excluding those with familial hypercholesterolemia or statin use. The lead sponsor is Novartis, with study sites in Lenexa, Kansas, and San Antonio, Texas.
Why it matters
Potential benefit: If successful, the new formulation could offer a safe and tolerable alternative for lower LDL-C in adults, potentially informing future therapy options.
How similar studies have gone: Similar PK/PD and tolerability comparisons between formulations have been explored in early-phase studies, though this exact PS80-containing formulation is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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ICON Early Clin Services Lenexa
Lenexa, Kansas, United States Recruiting -
Lenexa Research Unit
Lenexa, Kansas, United States Recruiting -
ICON Early Clin Service San Antonio
San Antonio, Texas, United States Recruiting -
Cardiovasular Renal Metabolism
San Antonio, Texas, United States Recruiting -
ICON Early Clinical Services SLC
Salt Lake City, Utah, United States Recruiting -
Salt Lake City Research Unit
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.