Primary HypercholesterolemiaPhase 4NCT06386419
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
A Phase 4 study testing inclisiran in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 9 sites in India.
Trial summary
This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- inclisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesIndia
- Study dates
- 12 Nov 2024to 13 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Indian participants aged ≥18 years or older.
- Participants for whom the treating physician prescribes treatment with inclisiran sodium in adherence with the India PI i.e., patients who are diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
- in combination with a statin or statin with other LLTs in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other LLTs in patients who are intolerant to statins or for whom a statin is contraindicated.
- Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.
Who cannot join
- Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
- Participants who have previous exposure to inclisiran sodium.
- Pregnant or nursing (lactating) women.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Novartis Investigative Site
Bangalore, Karnataka, 560099
Novartis Investigative Site
Belagavi, Karnataka, 590010
Novartis Investigative Site
Jaipur, Rajasthan, 302039
Novartis Investigative Site
Kolkata, West Bengal, 700 020
Novartis Investigative Site
Madurai, Tamil Nadu, 625107
Novartis Investigative Site
Mumbai, Maharashtra, 400012
Novartis Investigative Site
Nagpur, Maharashtra, 441108
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110029
Novartis Investigative Site
Vellore, Tamil Nadu, 632 004
About this study
Official title: A Real-world, Prospective, Multi-center, Open-label, Phase 4 Clinical Study to Evaluate the Safety and Effectiveness of Subcutaneous Injection of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium.
Read the detailed description
This is a prospective, multi-center, single-arm, open-label, interventional Phase 4 clinical study and will be conducted across several sites in India.
The study consists of:
- Open-label treatment period: The open-label treatment period will be of 270 days during which 3 single doses of inclisiran sodium will be administered subcutaneously (SC) on Day 1, Day 90, and Day 270, respectively. On Day 1/Dose 1 visit, the patients will be assessed by the Investigator for their eligibility to receive inclisiran sodium based on their medical history and previous lipid test reports. The study treatment i.e., inclisiran sodium will be prescribed as per the latest India Prescribing Information (PI). The assignment of the participant to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the participant in the study.
- Safety follow-up period: The safety follow-up will be performed 30 days after each dose administration of the study treatment i.e., Day 30, Day 120, and Day 300. The follow-up on Day 30 and Day 120 visits will be conducted telephonically while Day 300 visit will be an onsite follow-up visit.
This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and New Drugs and Clinical Trials (NDCT) Rules, 2019 requirements.
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Being tested
- inclisiran
- Keywords
- Inclisiran,, primary hypercholesterolemia, mixed dyslipidemia, ASCVD, PCSK9, Phase 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclisiranDrug
Also called KJX839
Inclisiran sodium 300 mg SC. Three single doses of inclisiran sodium will be administered to the participants on Day 1, Day 90, and Day 270, respectively
| Study group | Role | What they receive |
|---|---|---|
| inclisiran | Experimental | 300 mg inclisiran sodium equivalent to 284 mg inclisiran administered as a single SC injection Receives: Drug: inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of treatment-emergent adverse events (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE will be defined as an AE that begins or that worsens in severity after at least 1 dose of the study treatment has been administered.
Measured: 10 months (300 days)
Secondary outcomes (4)
Mean change in LDL-C from baseline to Day 300.
Mean change in LDL-C from baseline to Day 300 to valuate the effectiveness of inclisiran sodium in terms of change in low-density lipoprotein cholesterol (LDL-C) levels.
Measured: Baseline, Day 300
Proportion of the participants with ≥50% LDL-C reduction on Day 300
Proportion of the participants with ≥50% LDL-C reduction on Day 300 to evaluate the effectiveness of inclisiran sodium in terms of change in low-density lipoprotein cholesterol (LDL-C) levels
Measured: Baseline, Day 300
Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk
global lipid targets for their level of ASCVD risk: 55 mg/dL for ASCVD very high-risk participants 70 mg/dL for ASCVD high-risk participants
Measured: Day 300
Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG
Percentage change in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, very low-density lipoprotein cholesterol (VLDL-C), and triglycerides (TG) to evaluate the effectiveness of inclisiran sodium in reducing other lipid markers from baseline to Day 300.
Measured: Baseline, Day 300
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start12 Nov 2024
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label assignment
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
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
- NCT06386419
- Sponsor's protocol ID
- CKJX839A1IN03
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Prospective, Multi-center, Open-label, Phase 4 Clinical Study to Evaluate the Safety and Effectiveness of Subcutaneous Injection of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT06386419
- Acronym / sponsor ID
- CKJX839A1IN03
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- Inclisiran,, primary hypercholesterolemia, mixed dyslipidemia, ASCVD, PCSK9, Phase 4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 26 Apr 2024 (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.
This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium.
Detailed description
This is a prospective, multi-center, single-arm, open-label, interventional Phase 4 clinical study and will be conducted across several sites in India.
The study consists of:
- Open-label treatment period: The open-label treatment period will be of 270 days during which 3 single doses of inclisiran sodium will be administered subcutaneously (SC) on Day 1, Day 90, and Day 270, respectively. On Day 1/Dose 1 visit, the patients will be assessed by the Investigator for their eligibility to receive inclisiran sodium based on their medical history and previous lipid test reports. The study treatment i.e., inclisiran sodium will be prescribed as per the latest India Prescribing Information (PI). The assignment of the participant to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the participant in the study.
- Safety follow-up period: The safety follow-up will be performed 30 days after each dose administration of the study treatment i.e., Day 30, Day 120, and Day 300. The follow-up on Day 30 and Day 120 visits will be conducted telephonically while Day 300 visit will be an onsite follow-up visit.
This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and New Drugs and Clinical Trials (NDCT) Rules, 2019 requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label assignment
| Arm | Type | Receives |
|---|---|---|
| inclisiran | Experimental | Drug: inclisiran300 mg inclisiran sodium equivalent to 284 mg inclisiran administered as a single SC injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female Indian participants aged ≥18 years or older.
- Participants for whom the treating physician prescribes treatment with inclisiran sodium in adherence with the India PI i.e., patients who are diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
- Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.
Key exclusion criteria (3 listed)
- Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
- Participants who have previous exposure to inclisiran sodium.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| inclisiranAlso: KJX839Inclisiran sodium 300 mg SC. Three single doses of inclisiran sodium will be administered to the participants on Day 1, Day 90, and Day 270, respectively | Drug | inclisiran |
Primary outcome
Incidence and type of treatment-emergent adverse events (TEAEs)
Time frame: 10 months (300 days)
An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE will be defined as an AE that begins or that worsens in severity after at least 1 dose of the study treatment has been administered.
4 secondary outcomes
Mean change in LDL-C from baseline to Day 300.
Time frame: Baseline, Day 300
Proportion of the participants with ≥50% LDL-C reduction on Day 300
Time frame: Baseline, Day 300
Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk
Time frame: Day 300
Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG
Time frame: Baseline, Day 300
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing inclisiran in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 9 sites in India.
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 5 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: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and type of treatment-emergent adverse events (TEAEs) (time frame: 10 months (300 days)). 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 23 Jun 2026.