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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)
Sponsor: Eli Lilly and Company
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
17300
Start Date
2024-03-05
Completion Date
2029-03
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Lepodisiran Sodium
Administered SC
Placebo
Administered SC
Locations (928)
Birmingham Clinical Research
Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC
Daphne, Alabama, United States
SEC Clinical Research
Dothan, Alabama, United States
Alliance for Multispecialty Research, LLC
Mobile, 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
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
Pima Heart
Tucson, Arizona, United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, United States
National Heart Institute
Beverly Hills, California, United States
Valley Clinical Trials, Inc.
Covina, California, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
HB Clinical Trials - Fountain Valley
Fountain Valley, California, United States
Care Access - Huntington Beach
Huntington Beach, California, United States
310 Clinical Research
Inglewood, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
First Valley Medical Group
Lancaster, California, United States
MemorialCare Health System - Long Beach Medical Center
Long Beach, California, United States
Ark Clinical Research
Long Beach, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
Cardiovascular Research Foundation of Southern California
Los Angeles, California, United States
Valley Clinical Trials, LLC dba Flourish Research
Northridge, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Care Access - Santa Clarita
Santa Clarita, California, United States
Stanford University Medical Center
Stanford, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Care Access - Thousand Oaks
Thousand Oaks, California, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
UCLA South Bay Endocrinology
Torrance, California, United States
InvivoCure
Van Nuys, California, United States
Synexus Clinical Research US, Inc.
Vista, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
Millennium Clinical Trials
Westlake Village, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Hartford Hospital (HH)
Hartford, Connecticut, United States
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Clearwater, Florida, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Elite Cardiac Research Center
Hialeah, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Largo, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
South Florida Clinical Research Institute
Margate, Florida, United States
Flourish Research - Miami, LLC
Miami, Florida, United States
Inpatient Research Clinic
Miami Lakes, Florida, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, United States
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Safety Harbor, Florida, United States
Care Access - Tamarac
Tamarac, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Care Access - Tampa
Tampa, Florida, United States
Cardiology Partners Clinical Research Institute - Wellington
Wellington, Florida, United States
American Clinical Trials - Acworth
Acworth, Georgia, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Southeastern Clinical Research Institute
Augusta, Georgia, United States
East Coast Institute for Research - Canton
Canton, Georgia, United States
American Clinical Trials - Douglasville
Douglasville, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Georgia Clinical Research - Lawrenceville
Lawrenceville, Georgia, United States
The Jones Center Clinical Research
Macon, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
High Desert Heart & Vascular
Meridian, Idaho, United States
Chicago Clinical Research Institute
Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
Clinical Investigation Specialists
Gurnee, Illinois, United States
Alliance for Multispecialty Research, LLC
Niles, Illinois, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, United States
Accellacare - DuPage
Winfield, Illinois, United States
American Health Network of Indiana, LLC - Avon
Avon, Indiana, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Care Access - South Indianapolis
Indianapolis, Indiana, United States
American Health Network of Indiana, LLC - Whiteland
Whiteland, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
AMR Clinical
Wichita, Kansas, United States
Qualmedica Research
Bowling Green, Kentucky, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States