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

Primary Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386419
• Other study ID #: CKJX839A1IN03
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 15, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 inclisiran sodium.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: August 30, 2025
• Est. primary completion date: August 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia
• Primary Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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