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)

JRCT ID: jRCT2051230205

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Atherosclerotic Cardiovascular Disease (ASCVD)
Elevated Lp(a)

• Date of first enrollment: 27/03/2024
• Target sample size: 12500
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Denmark,Japan,Germany,Japan,Hungary,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Lepodisiran Sodium
Administered SC
Other Name: LY3819469
Drug: Placebo
Administered SC
[Study Arms]
Experimental: Lepodisiran Sodium
Lepodisiran sodium administered subcutaneously (SC).
Intervention: Drug: Lepodisiran Sodium
Placebo Comparator: Placebo
Placebo administered SC.
Intervention: Drug: Placebo

Outcome(s)

Primary Outcome

Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint [ Time Frame: Baseline up to End of Study (About 4.5 Years) ]
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and urgent coronary revascularization.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06292013