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NCT Number: NCT06292013

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clínica Privada del Prado SRL, Alberdi, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, < 60 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, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening.

Treatment and study plan

Lepodisiran Sodium

Drug

Administered SC

Other names: LY3819469

Placebo

Drug

Administered SC

Primary outcomes

  1. 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 ischemic stroke, and urgent coronary revascularization.

Secondary outcomes

  1. Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4

    Time frame: Baseline, Week 4

    Change from Baseline in Lp(a)

  2. Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first occurrence MACE-3

  3. Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first occurrence of fatal or non-fatal myocardial infarction.

  4. Time to Cardiovascular Death

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to cardiovascular death.

  5. Time to Occurrence of All-Cause Death

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to occurrence of all-cause death

  6. Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization)

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first occurrence of any component of the MACE-4 composite endpoint.

  7. Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event)

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first occurrence of any component of the MACE-4 composite endpoint.

  8. Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) ≥ 200 nmol/L)

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first occurrence of any component of the MACE-4 composite endpoint.

  9. Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first occurrence of any component of MACE-3 + MALE composite endpoint.

  10. Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint

    Time frame: Baseline up to End of Study (About 4.5 Years)

    Time to first Occurrence of any component of coronary MACE-3 composite endpoint.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 4, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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