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)

Conditions

• Atherosclerotic Cardiovascular Disease (ASCVD)
• Elevated Lp(a)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lepodisiran Sodium — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.

Key Dates

Start date

Mar 5, 2024

Status verified

May 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

17,300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lepodisiran Sodium
  Lepodisiran sodium administered subcutaneously (SC).
• Placebo Comparator: Placebo
  Placebo administered SC.

Primary Outcome Measure

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) ]

Locations (222)

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