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)

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

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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