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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06292013
Other study ID # 18812
Secondary ID J3L-MC-EZEF2023-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 5, 2024
Est. completion date March 2029

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lepodisiran Sodium
Administered SC
Placebo
Administered SC

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Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Romania,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and urgent coronary revascularization. Baseline up to End of Study (About 4.5 Years)
Secondary Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4 Change from Baseline in Lp(a) Baseline, Week 4
Secondary Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint Time to first occurrence MACE-3 Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction Time to first occurrence of fatal or non-fatal myocardial infarction. Baseline up to End of Study (About 4.5 Years)
Secondary Time to Cardiovascular Death Time to cardiovascular death. Baseline up to End of Study (About 4.5 Years)
Secondary Time to Occurrence of All-Cause Death Time to occurrence of all-cause death Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization) Time to first occurrence of any component of the MACE-4 composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event) Time to first occurrence of any component of the MACE-4 composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) = 200 nmol/L) Time to first occurrence of any component of the MACE-4 composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint Time to first occurrence of any component of MACE-3 + MALE composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint Time to first Occurrence of any component of coronary MACE-3 composite endpoint. Baseline up to End of Study (About 4.5 Years)

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