Inclisiran FormulationPhase 1NCT07626281
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
A Phase 1 study testing Inclisiran formulation containing PS80 and Currently marketed inclisiran formulation in people with Inclisiran Formulation, run by Novartis Pharmaceuticals at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inclisiran Formulation
- What is being tested?
- Inclisiran formulation containing PS80 and Currently marketed inclisiran formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Jun 2026to 21 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
ICON Early Clin Services Lenexa
Lenexa, Kansas, 66219
Patrick Yao
- Recruiting
Lenexa Research Unit
Lenexa, Kansas, 66219
- Recruiting
ICON Early Clinical Services SLC
Salt Lake City, Utah, 84124
Julia Garcia
- Recruiting
Salt Lake City Research Unit
Salt Lake City, Utah, 84124
- Recruiting
ICON Early Clin Service San Antonio
San Antonio, Texas, 78209
Chinonye Ogbonnaya-Odor
- Recruiting
Cardiovasular Renal Metabolism
San Antonio, Texas, 78232
About this study
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
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.
Read the detailed description
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.
- Conditions
- Inclisiran Formulation
- Being tested
- Inclisiran formulation containing PS80, Currently marketed inclisiran formulation
- Keywords
- Inclisiran containing polysorbate 80, healthy male and female participants, safety, tolerability, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclisiran formulation containing PS80Drug
Also called KJX839
Inclisiran 284 mg
Currently marketed inclisiran formulationDrug
Also called KJX839
Inclisiran 284 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm A (inclisiran - currently marketed formulation) | Active comparator | Inclisiran 284 mg × 1 single dose on Day 1 Receives: Drug: Currently marketed inclisiran formulation |
| Arm B (inclisiran - formulation containing PS80) | Experimental | Inclisiran 284 mg × 1 single dose on Day 1 Receives: Drug: Inclisiran formulation containing PS80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary plasma PK parameters: Cmax
Cmax = maximum observed plasma concentration
Measured: Day 1, Day 2, Day 3 and Day 4
Primary plasma PK parameters: AUClast
AUClast = AUC from time zero to the last measurable concentration sampling time
Measured: Day 1, Day 2, Day 3 and Day 4
Primary plasma PK parameters: AUCinf
AUCinf = AUC from time zero to infinity
Measured: Day 1, Day 2, Day 3 and Day 4
Additional PK parameters: AUC0-24hr
AUC0-24hr = AUC from time zero to 24 hours
Measured: Day 1, Day 2, Day 3 and Day 4
Additional PK parameters: Tmax
Tmax = time to reach maximum plasma concentration
Measured: Day 1, Day 2, Day 3 and Day 4
Additional PK parameters: T1/2
T1/2 = elimination half-life
Measured: Day 1, Day 2, Day 3 and Day 4
Additional PK parameters: CL/F
CL/F = total body clearance
Measured: Day 1, Day 2, Day 3 and Day 4
Additional PK parameters: Vz/F
Vz/F = apparent volume of distribution
Measured: Day 1, Day 2, Day 3 and Day 4
Secondary outcomes (1)
Number of participants with AEs
Number of participants with AEs, including abnormal vital signs, ECGs, injection site reactions and safety laboratory parameters.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start9 Jun 2026
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclisiran FormulationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626281
- Sponsor's protocol ID
- CKJX839A12107
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07626281
- Acronym / sponsor ID
- CKJX839A12107
- Conditions
- Inclisiran Formulation
- Keywords
- Inclisiran containing polysorbate 80, healthy male and female participants, safety, tolerability, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (inclisiran - currently marketed formulation) | Active comparator | Drug: Currently marketed inclisiran formulationInclisiran 284 mg × 1 single dose on Day 1 |
| Arm B (inclisiran - formulation containing PS80) | Experimental | Drug: Inclisiran formulation containing PS80Inclisiran 284 mg × 1 single dose on Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclisiran formulation containing PS80Also: KJX839Inclisiran 284 mg | Drug | Arm B (inclisiran - formulation containing PS80) |
| Currently marketed inclisiran formulationAlso: KJX839Inclisiran 284 mg | Drug | Arm A (inclisiran - currently marketed formulation) |
Primary outcome
Primary plasma PK parameters: Cmax
Time frame: Day 1, Day 2, Day 3 and Day 4
Cmax = maximum observed plasma concentration
Primary plasma PK parameters: AUClast
Time frame: Day 1, Day 2, Day 3 and Day 4
AUClast = AUC from time zero to the last measurable concentration sampling time
Primary plasma PK parameters: AUCinf
Time frame: Day 1, Day 2, Day 3 and Day 4
AUCinf = AUC from time zero to infinity
Additional PK parameters: AUC0-24hr
Time frame: Day 1, Day 2, Day 3 and Day 4
AUC0-24hr = AUC from time zero to 24 hours
Additional PK parameters: Tmax
Time frame: Day 1, Day 2, Day 3 and Day 4
Tmax = time to reach maximum plasma concentration
Additional PK parameters: T1/2
Time frame: Day 1, Day 2, Day 3 and Day 4
T1/2 = elimination half-life
Additional PK parameters: CL/F
Time frame: Day 1, Day 2, Day 3 and Day 4
CL/F = total body clearance
Additional PK parameters: Vz/F
Time frame: Day 1, Day 2, Day 3 and Day 4
Vz/F = apparent volume of distribution
1 secondary outcome
Number of participants with AEs
Time frame: Up to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inclisiran formulation containing PS80 and Currently marketed inclisiran formulation in people with Inclisiran Formulation, run by Novartis Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary plasma PK parameters: Cmax (time frame: Day 1, Day 2, Day 3 and Day 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.