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Spectrum Clinical Research | Maryland Cardiovascular Specialists

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A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)
Elevated Lp(a)

Treatments

Drug: Lepodisiran Sodium
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06292013
2023-509190-23 (EudraCT Number)
J3L-MC-EZEF (Other Identifier)
18812

Details and patient eligibility

About

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).

Enrollment

12,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

12,500 participants in 2 patient groups, including a placebo group

Lepodisiran Sodium
Experimental group
Description:
Lepodisiran sodium administered subcutaneously (SC).
Treatment:
Drug: Lepodisiran Sodium
Placebo
Placebo Comparator group
Description:
Placebo administered SC.
Treatment:
Drug: Placebo

Trial contacts and locations

934

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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