ACTIVE_NOT_RECRUITING

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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Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)Elevated Lp(a)ASCVDLY3819469lepodisiran

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-03-05
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06292013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L).
  2. * Meet criteria of either 2a or 2b:
  1. * Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, \< 60 days before screening
  2. * Have uncontrolled hypertension
  3. * Have New York Heart Association class IV heart failure.
  4. * Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
  5. * Have severe renal failure, defined as
  6. * Estimated glomerular rate (eGFR) \<15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
  7. * Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
  8. * 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.

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Birmingham Clinical Research
Birmingham, Alabama, 35209
United States
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526
United States
SEC Clinical Research
Dothan, Alabama, 36305
United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608
United States
Mobile Heart Specialists
Mobile, Alabama, 36608
United States
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona, 85296
United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
United States
Sun City Clinical Research
Glendale, Arizona, 85304
United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
United States
Helios Clinical Research - Phoenix
Phoenix, Arizona, 85028
United States
Absolute Clinical Research
Phoenix, Arizona, 85051
United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, 85375
United States
Pima Heart
Tucson, Arizona, 85741
United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741
United States
Eclipse Clinical Research
Tucson, Arizona, 85745
United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
United States
National Heart Institute
Beverly Hills, California, 90211
United States
Valley Clinical Trials, Inc.
Covina, California, 91723
United States
Neighborhood Healthcare Institute of Health
Escondido, California, 92025
United States
HB Clinical Trials - Fountain Valley
Fountain Valley, California, 92708
United States
Care Access - Huntington Beach
Huntington Beach, California, 92648
United States
310 Clinical Research
Inglewood, California, 90301
United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037-7410
United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
United States
First Valley Medical Group
Lancaster, California, 93534
United States
MemorialCare Health System - Long Beach Medical Center
Long Beach, California, 90806
United States
Ark Clinical Research
Long Beach, California, 90815
United States
Keck School of Medicine of USC
Los Angeles, California, 90033
United States
Cardiovascular Research Foundation of Southern California
Los Angeles, California, 90210
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
United States
Artemis Institute for Clinical Research
San Diego, California, 92123
United States
Care Access - Santa Clarita
Santa Clarita, California, 91321
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Olive View-UCLA Medical Center
Sylmar, California, 91342
United States
Care Access - Thousand Oaks
Thousand Oaks, California, 91360
United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, 91602
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
UCLA South Bay Endocrinology
Torrance, California, 90505
United States
InvivoCure
Van Nuys, California, 91405
United States
Synexus Clinical Research US, Inc.
Vista, California, 92083
United States
Interventional Cardiology Medical Group
West Hills, California, 91307
United States
Millennium Clinical Trials
Westlake Village, California, 91361
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610
United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
United States
Hartford Hospital (HH)
Hartford, Connecticut, 06102
United States
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut, 06905
United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Clearwater, Florida, 33756
United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
United States
Elite Cardiac Research Center
Hialeah, Florida, 33013
United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Largo, Florida, 33777
United States
K2 Medical Research - Maitland
Maitland, Florida, 32751
United States
South Florida Clinical Research Institute
Margate, Florida, 33063
United States
Flourish Research - Miami, LLC
Miami, Florida, 33135
United States
Inpatient Research Clinic
Miami Lakes, Florida, 33014
United States
Advanced Research for Health Improvement, LLC
Naples, Florida, 34102
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
CTR Oakwater, LLC
Orlando, Florida, 32806
United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, 32825
United States
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida, 33952
United States
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Safety Harbor, Florida, 34695
United States
Care Access - Tamarac
Tamarac, Florida, 33321
United States
Clinical Research of West Florida
Tampa, Florida, 33606
United States
Care Access - Tampa
Tampa, Florida, 33625
United States
Cardiology Partners Clinical Research Institute - Wellington
Wellington, Florida, 33449
United States
American Clinical Trials - Acworth
Acworth, Georgia, 30101
United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Southeastern Clinical Research Institute
Augusta, Georgia, 30904
United States
East Coast Institute for Research - Canton
Canton, Georgia, 30114
United States
American Clinical Trials - Douglasville
Douglasville, Georgia, 30134
United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501
United States
Georgia Clinical Research - Lawrenceville
Lawrenceville, Georgia, 30044
United States
The Jones Center Clinical Research
Macon, Georgia, 31210
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
CARE Institute
Meridian, Idaho, 83642
United States
Chicago Clinical Research Institute
Chicago, Illinois, 60607
United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
United States
Clinical Investigation Specialists
Gurnee, Illinois, 60031
United States
Alliance for Multispecialty Research, LLC
Park Ridge, Illinois, 60068
United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711
United States
Accellacare - DuPage
Winfield, Illinois, 60190
United States
American Health Network of Indiana, LLC - Avon
Avon, Indiana, 46123
United States
American Health Network of Indiana, LLC - Franklin
Franklin, Indiana, 46131
United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46254
United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67226
United States
Qualmedica Research
Bowling Green, Kentucky, 42101
United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
United States
Grace Research - Bossier
Bossier City, Louisiana, 71111
United States
Care Access - Lake Charles
Lake Charles, Louisiana, 70601
United States
IMA Clinical Research
Monroe, Louisiana, 71201
United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119
United States
Louisiana Heart Center - Slidell
Slidell, Louisiana, 70458
United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21209
United States
Care Access - Baltimore
Baltimore, Maryland, 21213
United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
United States
Jadestone Clinical Research
Beltsville, Maryland, 20705
United States
Flourish Research - Bowie
Bowie, Maryland, 20715
United States
Kur Research - Columbia Medical
Columbia, Maryland, 21045
United States
Anderson Medical Research
Ft. Washington, Maryland, 20744
United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782
United States
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, 02115
United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721
United States
Care Access - Quincy
Quincy, Massachusetts, 02169
United States
Alliance for Multispecialty Research, LLC.
Dearborn, Michigan, 48126
United States
Revival Research Institute, LLC
Dearborn, Michigan, 48126
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
United States
Michigan Heart & Vascular Institute
Ypsilanti, Michigan, 48197
United States
The National Diabetes & Obesity Research Institute
Diamondhead, Mississippi, 39525
United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303
United States
Clinvest Headlands Llc
Springfield, Missouri, 65807
United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
United States
Las Vegas Endocrinology
Henderson, Nevada, 89074
United States
DaVita Clinical Research - Las Vegas
Las Vegas, Nevada, 89107
United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
United States
Vector Clinical Trials
Las Vegas, Nevada, 89128
United States
Internal Medicine Associates
Bridgeton, New Jersey, 08302
United States
Cardio Metabolic Institute
Somerset, New Jersey, 08873
United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901
United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
United States
IMA Clinical Research
Albuquerque, New Mexico, 87109
United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, 12203
United States
St. Francis Hospital & Heart Center
New Hyde Park, New York, 11576
United States
NYU Langone Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
IMA Clinical Research Manhattan
New York, New York, 10036
United States
Lenox Hill Hospital
New York, New York, 10075
United States
Northwell Health Physician Peconic
Riverhead, New York, 11901
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Saratoga Clinical Research
Saratoga Springs, New York, 12866
United States
Stony Brook University
Stony Brook, New York, 11794
United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314
United States
Medication Management
Greensboro, North Carolina, 27405
United States
Triad Clinical Trials
Greensboro, North Carolina, 27410
United States
Physician's East Endocrinology
Greenville, North Carolina, 27834
United States
IMA Clinical Research Mount Airy
Mount Airy, North Carolina, 27030
United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609
United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
United States
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, 45219
United States
Velocity Clinical Research, Springdale
Cincinnati, Ohio, 45246
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ohio State University
Columbus, Ohio, 43210
United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213
United States
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, 15009
United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
United States
Abington Medical Specialists
Horsham, Pennsylvania, 19044
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
United States
Cardiology Consultants of Philadelphia Yardley
Yardley, Pennsylvania, 19067
United States
Heart and Vascular Research at WellSpan Health
York, Pennsylvania, 17403
United States
Accellacare Trident Cardiology
Charleston, South Carolina, 29456
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
Walker Family Care
Little River, South Carolina, 29566
United States
Care Access - Mauldin
Mauldin, South Carolina, 29662
United States
Accellacare - Mt Pleasant
Mt. Pleasant, South Carolina, 29464
United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
United States
Care Access - Memphis 2
Memphis, Tennessee, 38119
United States
PharmaTex Research
Amarillo, Texas, 79106
United States
Amarillo Heart Clinical Research Institute Inc.
Amarillo, Texas, 79124
United States
IMA Clinical Research Austin
Austin, Texas, 78745
United States
Velocity Clinical Research, Austin
Austin, Texas, 78759
United States
Headlands Horizons LLC
Brownsville, Texas, 78526
United States
South Texas Clinical Research
Corpus Christi, Texas, 78404
United States
Private Practice - Dr. James E. Race
Dallas, Texas, 75224
United States
Baylor Soltero CV Research Center
Dallas, Texas, 75226
United States
Zenos Clinical Research
Dallas, Texas, 75230
United States
Cedar Health Research
Dallas, Texas, 75251
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Cardio Voyage
Denison, Texas, 75020
United States
South Texas Research Institute
Edinburg, Texas, 78539
United States
Texas Health Research & Education Institute - Fort Worth
Fort Worth, Texas, 76104
United States
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine
Houston, Texas, 77030
United States
Juno Research
Houston, Texas, 77040
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Research Physicians Network, LLC
Houston, Texas, 77089
United States
Accurate Clinical Research - Humble
Humble, Texas, 77338
United States
The Heart Institute of East Texas
Lufkin, Texas, 75904
United States
Biopharma Informatic, LLC
McAllen, Texas, 78503
United States
Wellness Clinical Research
McKinney, Texas, 75069
United States
North Texas Research Associates
McKinney, Texas, 75071
United States
Revival Research Institute, LLC
McKinney, Texas, 75071
United States
Texas Institute of Cardiology, PA
McKinney, Texas, 75071
United States
PRX Research
Mesquite, Texas, 75149
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Clinical Advancement Center
San Antonio, Texas, 78212
United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
United States
Endeavor Clinical Trials
San Antonio, Texas, 78240
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
DaVita Clinical Research - North Houston
Shenandoah, Texas, 77384
United States
Sherman Clinical Research
Sherman, Texas, 75090
United States
Alpine Research Organization
Clinton, Utah, 84015
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
Virginia Heart
Falls Church, Virginia, 22042
United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502
United States
Eastside Research Associates
Redmond, Washington, 98052
United States
IMA Clinical Research West Virginia
Morgantown, West Virginia, 26505
United States
Clinical Investigation Specialists
Kenosha, Wisconsin, 53144
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-05
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-03-05
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • ASCVD
  • LY3819469
  • lepodisiran

Additional Relevant MeSH Terms

  • Atherosclerotic Cardiovascular Disease (ASCVD)
  • Elevated Lp(a)