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)

Phase 3

Recruiting

• Conditions: Atherosclerotic Cardiovascular Disease (ASCVD); Elevated Lp(a)
• Interventions: Drug: Placebo; Drug: Lepodisiran Sodium

• Registration Number: NCT06292013
• Lead Sponsor: 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). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Study Start: 2024-03-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2029-03
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered SC.
Lepodisiran Sodium	Lepodisiran Sodium	Lepodisiran sodium administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint	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 Outcome Measures

Name	Time	Method
Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction	Baseline up to End of Study (About 4.5 Years)	Time to first occurrence of fatal or non-fatal myocardial infarction.
Time to Occurrence of All-Cause Death	Baseline up to End of Study (About 4.5 Years)	Time to occurrence of all-cause death
Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) ≥ 200 nmol/L)	Baseline up to End of Study (About 4.5 Years)	Time to first occurrence of any component of the MACE-4 composite endpoint.
Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint	Baseline up to End of Study (About 4.5 Years)	Time to first occurrence of any component of MACE-3 + MALE composite endpoint.
Time to Cardiovascular Death	Baseline up to End of Study (About 4.5 Years)	Time to cardiovascular death.
Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization)	Baseline up to End of Study (About 4.5 Years)	Time to first occurrence of any component of the MACE-4 composite endpoint.
Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4	Baseline, Week 4	Change from Baseline in Lp(a)
Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint	Baseline up to End of Study (About 4.5 Years)	Time to first occurrence MACE-3
Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint	Baseline up to End of Study (About 4.5 Years)	Time to first Occurrence of any component of coronary MACE-3 composite endpoint.
Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event)	Baseline up to End of Study (About 4.5 Years)	Time to first occurrence of any component of the MACE-4 composite endpoint.

Trial Locations

Locations (922)

Birmingham Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norfolk, Virginia, United States

SEC Clinical Research; 🇺🇸 Dothan, Alabama, United States

Mobile Heart Specialists; 🇺🇸 Mobile, Alabama, United States

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC; 🇺🇸 Gilbert, Arizona, United States

Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Sun City Clinical Research; 🇺🇸 Glendale, Arizona, United States

Elite Clinical Studies, LLC; 🇺🇸 Phoenix, Arizona, United States

Helios Clinical Research - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Absolute Clinical Research; 🇺🇸 Phoenix, Arizona, United States

Scroll for more (912 remaining)