Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around
Principal Investigator
by Michael Wilkinson (ucsd)Jonathan Soverow (ucla)William French (ucla)Dianne Cheung (ucla)
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
  • Olive View-UCLA Medical Center not yet accepting patients
    Sylmar California 91342 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • UCLA South Bay Endocrinology accepting new patients
    Torrance California 90505 United States
  • Scripps Whittier Diabetes Institute not yet accepting patients
    La Jolla California 92037 United States
  • Cardiovascular Research Foundation of Southern California not yet accepting patients
    Los Angeles California 90210 United States
  • Westside Medical Associates of Los Angeles accepting new patients
    Beverly Hills California 90211 United States
  • HB Clinical Trials - Fountain Valley accepting new patients
    Fountain Valley California 92708 United States
  • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. accepting new patients
    Toluca Lake California 91602 United States
  • Care Access Research - Huntington Beach accepting new patients
    Huntington Beach California 92648 United States

Lead Scientists at University of California Health

  • Michael Wilkinson (ucsd)
    Assistant Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 17 research publications
  • Jonathan Soverow (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 18 research publications
  • William French (ucla)
    Adjunct Professor, Medicine. Authored (or co-authored) 97 research publications
  • Dianne Cheung (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 7 research publications

Details

Status
accepting new patients
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