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RNA-based Therapeutic

Inclisiran for Cardiovascular Disease Prevention

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants at an increased risk for a first MACE (i.e., no prior major ASCVD event)
Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors
Must not have
History of major ASCVD event
Timeline
Screening 1 day
Treatment Varies
Follow Up time to the first occurrence of 4p-mace (up to approximately 75 months)
Awards & highlights

Summary

This trial tests if inclisiran sodium can reduce the risk of major cardiovascular events in people at high risk of heart disease.

Who is the study for?
This trial is for adults aged 40-80 with high cholesterol and at increased risk of a first major cardiovascular event, but who haven't had one before. They should have an intermediate 10-year heart disease risk score with additional risk factors. Pregnant women, nursing mothers, or those in another study can't participate.Check my eligibility
What is being tested?
The trial tests if Inclisiran sodium (a drug given by injection) can prevent serious heart-related events when administered initially, after three months, and then every six months compared to a placebo. The goal is to see if it reduces the occurrence of events like heart attacks or strokes.See study design
What are the potential side effects?
While specific side effects are not listed here, Inclisiran may cause reactions at the injection site, allergic responses, liver enzyme changes, muscle pain or weakness among others based on its mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a higher risk of experiencing a first major cardiovascular event and have not had one before.
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My heart disease risk for the next 10 years is between 7.5% and 20%, and I have at least two risk factors.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a major heart or blood vessel event.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~time to the first occurrence of 4p-mace (up to approximately 75 months)
This trial's timeline: 1 day for screening, Varies for treatment, and time to the first occurrence of 4p-mace (up to approximately 75 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to the first occurrence of 4P-MACE
Secondary outcome measures
Time to occurrence of Cardiovascular death
Time to occurrence of death due to any reason
Time to the first occurrence of 3P-MACE
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inclisiran Sodium 300mgExperimental Treatment1 Intervention
Inclisiran sodium 300 mg in 1.5 mL Solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 2 Diabetes include SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors. SGLT2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion and improved glycemic control. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps regulate blood sugar levels and promotes weight loss. DPP-4 inhibitors prolong the action of incretin hormones, thereby increasing insulin release and decreasing glucagon levels. These mechanisms are crucial for T2D patients as they not only improve blood sugar control but also offer cardiovascular benefits, which is particularly important given the high cardiovascular risk associated with diabetes. While Inclisiran Sodium (a PCSK9 inhibitor) is primarily used to lower LDL cholesterol and reduce cardiovascular events, its inclusion in diabetes management highlights the importance of comprehensive cardiovascular risk reduction in T2D patients.
Effect of dapagliflozin on diabetic patients with cardiovascular disease via MAPK signalling pathway.Cardiovascular Safety and Benefits of Noninsulin Antihyperglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus: Part 2.The EMPA-REG outcome study: critical appraisal and potential clinical implications.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,185,991 Total Patients Enrolled

Media Library

Inclisiran sodium (RNA-based Therapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT05739383 — Phase 3
Type 2 Diabetes Research Study Groups: Inclisiran Sodium 300mg, Placebo
Type 2 Diabetes Clinical Trial 2023: Inclisiran sodium Highlights & Side Effects. Trial Name: NCT05739383 — Phase 3
Inclisiran sodium (RNA-based Therapeutic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05739383 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05739383 — Phase 3
~9333 spots leftby Apr 2029