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Clinical Trials in the USA / NCT06292013
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-03-05
Last updated
2026-08-24

Condition(s) studied

Atherosclerotic Cardiovascular Disease (ASCVD)Elevated Lp(a)

Investigational drug(s) / intervention(s)

Lepodisiran SodiumPlacebo

Lepodisiran Sodium: Administered SC

Placebo: Administered SC

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (928)

FacilityCityRegionStatus
Birmingham Clinical Research Birmingham Alabama
Alliance for Multispecialty Research, LLC Daphne Alabama
SEC Clinical Research Dothan Alabama
Alliance for Multispecialty Research, LLC Mobile Alabama
Mobile Heart Specialists Mobile Alabama
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC Gilbert Arizona
Mercy Gilbert Medical Center Gilbert Arizona
Sun City Clinical Research Glendale Arizona
Elite Clinical Studies, LLC Phoenix Arizona
Helios Clinical Research - Phoenix Phoenix Arizona
Absolute Clinical Research Phoenix Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West Sun City West Arizona
Pima Heart Tucson Arizona
Synexus Clinical Research US, Inc./Orange Grove Family Practice Tucson Arizona
Eclipse Clinical Research Tucson Arizona
Cardiology and Medicine Clinic Little Rock Arkansas
National Heart Institute Beverly Hills California
Valley Clinical Trials, Inc. Covina California
Neighborhood Healthcare Institute of Health Escondido California
HB Clinical Trials - Fountain Valley Fountain Valley California
Care Access - Huntington Beach Huntington Beach California
310 Clinical Research Inglewood California
UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California
Scripps Whittier Diabetes Institute La Jolla California
First Valley Medical Group Lancaster California
MemorialCare Health System - Long Beach Medical Center Long Beach California
Ark Clinical Research Long Beach California
Keck School of Medicine of USC Los Angeles California
Cardiovascular Research Foundation of Southern California Los Angeles California
Valley Clinical Trials, LLC dba Flourish Research Northridge California
Desert Oasis Healthcare Medical Group Palm Springs California
Artemis Institute for Clinical Research San Diego California
Care Access - Santa Clarita Santa Clarita California
Stanford University Medical Center Stanford California
Olive View-UCLA Medical Center Sylmar California
Care Access - Thousand Oaks Thousand Oaks California
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. Toluca Lake California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
UCLA South Bay Endocrinology Torrance California
InvivoCure Van Nuys California

+ 888 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06292013 on ClinicalTrials.gov ↗ ← All trials in the USA