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RNA-targeted therapy

Lepodisiran for Cardiovascular Disease

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to end of study (about 4.5 years)
Awards & highlights
Pivotal Trial

Summary

This trial is testing lepodisiran, a medication given as an injection under the skin. It targets people with high levels of lipoprotein(a) who have cardiovascular disease or are at risk of heart attack or stroke. The medication works by lowering lipoprotein(a) levels to reduce the risk of these cardiovascular events.

Who is the study for?
This trial is for adults with high levels of lipoprotein(a), a type of fat in the blood, who either have cardiovascular disease or are at risk for heart attacks or strokes. Details on specific inclusion and exclusion criteria were not provided.
What is being tested?
The study is testing Lepodisiran Sodium's ability to lower the risk of major adverse cardiovascular events compared to a placebo. Participants will receive the drug through an injection under their skin.
What are the potential side effects?
Specific side effects related to Lepodisiran Sodium were not detailed, but typically such medications may cause reactions at the injection site, potential liver issues, and allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of study (about 4.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (about 4.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Secondary study objectives
Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4
Time to Cardiovascular Death
Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lepodisiran SodiumExperimental Treatment1 Intervention
Lepodisiran sodium administered subcutaneously (SC).
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered SC.

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
Lepodisiran, an investigational drug, reduces cardiovascular risk by lowering elevated lipoprotein(a) levels through subcutaneous administration. PCSK9 inhibitors, such as alirocumab and evolocumab, work by inhibiting the PCSK9 enzyme, which increases the number of LDL receptors on liver cells, thereby reducing LDL-C and potentially Lp(a) levels. Ezetimibe, although primarily used to lower LDL-C by inhibiting cholesterol absorption in the intestine, has shown a small reduction in Lp(a) levels. These treatments are crucial for patients with elevated Lp(a) because high levels are associated with an increased risk of cardiovascular events, such as heart attacks and strokes. Lowering Lp(a) can therefore significantly reduce this risk.
Effect of Ezetimibe Monotherapy on Plasma Lipoprotein(a) Concentrations in Patients with Primary Hypercholesterolemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,677 Previous Clinical Trials
3,453,131 Total Patients Enrolled
1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
~8333 spots leftby Mar 2029
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