Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Michael Wilkinson
Headshot of Michael Wilkinson
Michael Wilkinson

Description

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).

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - ACCLAIM-Lp(a)

Keywords

Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lp(a), ASCVD, LY3819469, lepodisiran, Cardiovascular Diseases, Atherosclerosis, Lepodisiran Sodium

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have Lipoprotein(a) [Lp(a)] ≥175 nanomoles per liter (nmol/L).
  • Meet criteria of either 2a or 2b:

    2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.

    2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.

You CAN'T join if...

  • Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening.
  • Have uncontrolled hypertension
  • Have New York Heart Association class IV heart failure.
  • Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
  • Have severe renal failure, defined as
    • Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
  • Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening.

Locations

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) not yet accepting patients
    La Jolla California 92037-7410 United States
  • Scripps Whittier Diabetes Institute not yet accepting patients
    La Jolla California 92037 United States
  • Artemis Institute for Clinical Research not yet accepting patients
    San Diego California 92103 United States
  • Neighborhood Healthcare Institute of Health accepting new patients
    Escondido California 92025 United States
  • Synexus Clinical Research US - Vista accepting new patients
    Vista California 92083 United States

Lead Scientist at UCSD

  • Michael Wilkinson
    Assistant Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 17 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
Related Info
ID
NCT06292013
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 12500 study participants
Last Updated