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RNA-targeted therapy

Lepodisiran Sodium for Elevated Lipoprotein

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

Study Summary

This trial aims to test whether lepodisiran can reduce the risk of heart disease in people with high lipoprotein(a) levels who already have heart disease or are at risk of a heart attack

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to end of study (about 4.5 years)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint

Secondary outcome measures

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,204,099 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently eligible to apply for participation in this ongoing medical study?

"According to clinicaltrials.gov, the current trial is not actively enrolling participants. The information was first posted on March 1st, 2024 and last updated on the same day. Despite this trial being inactive for recruitment at present, there are numerous other studies seeking volunteers; specifically, 556 trials are presently recruiting participants."

Answered by AI

In how many medical facilities is this examination being conducted?

"IBPClin - Instituto Brasil de Pesquisa Clínica in Rio de Janeiro, Nordjylland, Sanos Clinic - Nordjylland in Gandrup, Rio Grande Do Sul and Hospital Moinhos de Vento in Porto Alegre, Pennsylvania are among the 12 additional sites where patients can enroll for this trial."

Answered by AI

Has the Food and Drug Administration officially sanctioned Lepodisiran Sodium for use?

"According to our analysis at Power, Lepodisiran Sodium has been rated a 3 for safety in this Phase 3 trial. This rating is indicative of existing efficacy data and substantial evidence supporting its safety profile."

Answered by AI