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)

NCT06292013
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
17,300
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Lead sponsor
Eli Lilly and Company
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Start date
2024-03-05
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Number of sites
928
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Summary
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.
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Short title
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)
clinicaltrials.gov
Official 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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-03-01
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First posted
2024-03-04
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Registry last updated
2026-08-24
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Primary completion date
2029-03-01
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Start date
2024-03-05
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Participants
17,300
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Participant count basis
Estimated
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Planned participants
17,300
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Protocol amendments
3
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Number of sites
928
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06292013
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ClinicalTrials.gov ID
NCT06292013
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint

    Timeframe: 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.

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

    Timeframe: Baseline, Week 4

    Change from Baseline in Lp(a)

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

    Timeframe: 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

    Timeframe: 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

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

    Time to cardiovascular death.

  5. Time to Occurrence of All-Cause Death

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

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

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
clinicaltrials.gov

  • Birmingham Clinical ResearchBirmingham, United States
  • Alliance for Multispecialty Research, LLCDaphne, United States
  • SEC Clinical ResearchDothan, United States
  • Alliance for Multispecialty Research, LLCMobile, United States
  • Mobile Heart SpecialistsMobile, United States
  • Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLCGilbert, United States
  • Mercy Gilbert Medical CenterGilbert, United States
  • Sun City Clinical ResearchGlendale, United States
  • Elite Clinical Studies, LLCPhoenix, United States
  • Helios Clinical Research - PhoenixPhoenix, United States
  • Absolute Clinical ResearchPhoenix, United States
  • Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United States
  • Pima HeartTucson, United States
  • Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, United States
  • Eclipse Clinical ResearchTucson, United States
  • Cardiology and Medicine ClinicLittle Rock, United States
  • National Heart InstituteBeverly Hills, United States
  • Valley Clinical Trials, Inc.Covina, United States
  • Neighborhood Healthcare Institute of HealthEscondido, United States
  • HB Clinical Trials - Fountain ValleyFountain Valley, United States
  • Care Access - Huntington BeachHuntington Beach, United States
  • 310 Clinical ResearchInglewood, United States
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United States
  • Scripps Whittier Diabetes InstituteLa Jolla, United States
  • First Valley Medical GroupLancaster, United States

And 903 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-509190-23
  • J3L-MC-EZEF
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)