NCT06386419

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-02-27
• Completion: 2026-02-27
• First posted: 2024-04-26
• Last updated: 2025-05-30

Locations

7 sites across 1 country: India