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

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.

Study Overview

• Status: Completed
• Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia
• Intervention / Treatment: Drug: inclisiran

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Novartis Investigative Site
    • Belagavi, Karnataka, India, 590010
      • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India, 441108
      • Novartis Investigative Site
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110029
      • Novartis Investigative Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302039
      • Novartis Investigative Site
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625107
      • Novartis Investigative Site
    • Vellore, Tamil Nadu, India, 632 004
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700 020
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female Indian participants aged ≥18 years or older.

2. 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:

   1. 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
   2. alone or in combination with other LLTs in patients who are intolerant to statins or for whom a statin is contraindicated.
3. Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment.

Exclusion Criteria:

1. 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.
2. Participants who have previous exposure to inclisiran sodium.
3. Pregnant or nursing (lactating) women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inclisiran; 300 mg inclisiran sodium equivalent to 284 mg inclisiran administered as a single SC injection	Drug: inclisiran; 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; Other Names: KJX839

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	Baseline, Day 300

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): January 13, 2026
• Study Completion (Actual): January 13, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PCSK9; ASCVD; Phase 4; mixed dyslipidemia; primary hypercholesterolemia; Inclisiran,
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Dyslipidemias; ALN-PCS
• Other Study ID Numbers: CKJX839A1IN03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No