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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)

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ClinicalTrials.gov Identifier: NCT06292013
Recruitment Status : Recruiting
First Posted : March 4, 2024
Last Update Posted : May 28, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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).

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease (ASCVD) Elevated Lp(a) Drug: Lepodisiran Sodium Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 5, 2024
Estimated Primary Completion Date : March 2029
Estimated Study Completion Date : March 2029

Arm Intervention/treatment
Experimental: Lepodisiran Sodium
Lepodisiran sodium administered subcutaneously (SC).
Drug: Lepodisiran Sodium
Administered SC
Other Name: LY3819469

Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  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 stroke, and urgent coronary revascularization.


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06292013


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT06292013    
Other Study ID Numbers: 18812
J3L-MC-EZEF ( Other Identifier: Eli Lilly and Company )
2023-509190-23 ( EudraCT Number )
First Posted: March 4, 2024    Key Record Dates
Last Update Posted: May 28, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
ASCVD
LY3819469
lepodisiran
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases