A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

NCT06386419 | Completed Phase 4

• 1 other identifier: CKJX839A1IN03
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 9

Brief 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 inclisiran sodium.

Conditions

Mixed Dyslipidemia; Primary Hypercholesterolemia

Keywords

Inclisiran,; primary hypercholesterolemia; mixed dyslipidemia; ASCVD; PCSK9; Phase 4

Outcome Measures

Primary Outcomes (1)

• 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.

  10 months (300 days)

Secondary Outcomes (4)

• Mean change in LDL-C from baseline to Day 300.

  Baseline, Day 300

• Proportion of the participants with ≥50% LDL-C reduction on Day 300

  Baseline, Day 300

• Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk

  Day 300

• Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG

  Baseline, Day 300

Study Arms (1)

inclisiran

EXPERIMENTAL

300 mg inclisiran sodium equivalent to 284 mg inclisiran administered as a single SC injection

Drug: inclisiran

Interventions

inclisiran DRUG

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

Also known as: KJX839

inclisiran

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Bangalore, Karnataka, 560099, India

Location

Novartis Investigative Site

Belagavi, Karnataka, 590010, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400012, India

Location

Novartis Investigative Site

Nagpur, Maharashtra, 441108, India

Location

Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Novartis Investigative Site

Jaipur, Rajasthan, 302039, India

Location

Novartis Investigative Site

Madurai, Tamil Nadu, 625107, India

Location

Novartis Investigative Site

Vellore, Tamil Nadu, 632 004, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700 020, India

Location

MeSH Terms

Interventions

ALN-PCS

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label assignment

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: November 12, 2024
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (9)