Clinical trial NCT06386419: A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Keywords: Inclisiran,
primary hypercholesterolemia
mixed dyslipidemia
ASCVD
PCSK9
Phase 4
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label assignment
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and type of treatment-emergent adverse events (TEAEs)
timeFrame: 10 months (300 days)
Secondary outcomes:
measure: Mean change in LDL-C from baseline to Day 300.
timeFrame: Baseline, Day 300
measure: Proportion of the participants with ≥50% LDL-C reduction on Day 300
timeFrame: Baseline, Day 300
measure: Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk
timeFrame: Day 300
measure: Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG
timeFrame: Baseline, Day 300
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Vellore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Madurai
country: India
facility: Novartis Investigative Site
state: TamilNadu
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: