Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
Purpose
The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
Conditions
- Elevated Lp(a)
- Atherosclerotic Cardiovascular Disease (ASCVD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have Lp(a) ≥175 nanomoles per liter (nmol/L) - Meet one of the following criteria: - Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening - Are at risk for a first ASCVD event, defined as one or more of the following: - Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event - A high coronary artery calcium (CAC) score - Reduced kidney function with diabetes - Combination(s) of high risk factors
Exclusion Criteria
- Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization - Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study - Have uncontrolled high blood pressure - Have New York Heart Association (NYHA) class III or IV heart failure - Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study - Have severe kidney impairment - Have had cancer within 5 years prior to screening
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Muvalaplin |
Participants will receive muvalaplin orally. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo orally. |
|
Recruiting Locations
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona 85296
Gilbert, Arizona 85296
Contact:
480-691-2213
480-691-2213
Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Phoenix, Arizona 85014
Phoenix, Arizona 85014
Contact:
602-730-9500
602-730-9500
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona 85375
Sun City West, Arizona 85375
Contact:
623-293-1360
623-293-1360
Southwest Kidney Institute - Surprise
Surprise, Arizona 85374
Surprise, Arizona 85374
Contact:
480-610-6100
480-610-6100
Pima Heart
Tucson, Arizona 85741
Tucson, Arizona 85741
Contact:
5203149254 ex 13563
5203149254 ex 13563
National Heart Institute
Beverly Hills, California 90211
Beverly Hills, California 90211
Contact:
310-289-9955
310-289-9955
John Muir Medical Center - Concord Campus
Concord, California 94520
Concord, California 94520
Contact:
925-674-2580
925-674-2580
Neighborhood Healthcare Institute of Health
Escondido, California 92025
Escondido, California 92025
Contact:
760-737-6984
760-737-6984
Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
Fountain Valley, California 92708
Contact:
714-988-2021
714-988-2021
Care Access - Huntington Beach
Huntington Beach, California 92648
Huntington Beach, California 92648
Contact:
714-378-2440
714-378-2440
The Cardiovascular Center
Redding, California 96001
Redding, California 96001
Contact:
281-944-3610
281-944-3610
UCLA South Bay Endocrinology
Torrance, California 90505
Torrance, California 90505
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Aurora, Colorado 80045
Contact:
303-724-4651
303-724-4651
Legacy Clinical Trials
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Contact:
719-387-7572
719-387-7572
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut 06905
Stamford, Connecticut 06905
Contact:
203-353-1133
203-353-1133
Chase Medical Research, LLC
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
Contact:
203-419-4420
203-419-4420
Excel Medical Clinical Trials
Boca Raton, Florida 33434
Boca Raton, Florida 33434
Contact:
305-631-6704
305-631-6704
American Research Institute
Cutler Bay, Florida 33157
Cutler Bay, Florida 33157
K2 Medical Research - Daytona Beach
Daytona Beach, Florida 32114
Daytona Beach, Florida 32114
Arrow Clinical Trials
Daytona Beach, Florida 32117
Daytona Beach, Florida 32117
Contact:
386-278-8000
386-278-8000
Soffer Health Institute
Hollywood, Florida 33020
Hollywood, Florida 33020
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Contact:
904-730-0101
904-730-0101
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159
Lady Lake, Florida 32159
Contact:
352-500-5252
352-500-5252
K2 Medical Research - Maitland
Maitland, Florida 32751
Maitland, Florida 32751
Contact:
407-810-2790
407-810-2790
K2 Medical Research ORLANDO
Maitland, Florida 32751
Maitland, Florida 32751
Contact:
407-500-5252
407-500-5252
Dade Florida Clinical Research Center
Miami, Florida 33173
Miami, Florida 33173
Contact:
786-409-6842
786-409-6842
Onhealth Research Center
Miami, Florida 33186
Miami, Florida 33186
Advanced Research for Health Improvement, LLC
Naples, Florida 34102
Naples, Florida 34102
Contact:
239-230-2021
239-230-2021
Renstar Medical Research
Ocala, Florida 34471
Ocala, Florida 34471
Contact:
352-629-5800
352-629-5800
Care Access - Tamarac
Tamarac, Florida 33321
Tamarac, Florida 33321
Contact:
877-791-0656
877-791-0656
Care Access - Tampa
Tampa, Florida 33625
Tampa, Florida 33625
Contact:
813-771-5980
813-771-5980
Masters of Clinical Research
Augusta, Georgia 30909
Augusta, Georgia 30909
Center for Advanced Research & Education
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Contact:
770-534-5154
770-534-5154
North Georgia Clinical Research
Woodstock, Georgia 30189
Woodstock, Georgia 30189
Contact:
678-494-5735
678-494-5735
Elite Clinical Trials
Blackfoot, Idaho 83221
Blackfoot, Idaho 83221
Contact:
208-643-0006
208-643-0006
CARE Institute - High Desert
Meridian, Idaho 83642
Meridian, Idaho 83642
Contact:
208-398-4306
208-398-4306
Elite Clinical Trials
Rexburg, Idaho 83440
Rexburg, Idaho 83440
Contact:
208-356-8977
208-356-8977
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640
Chicago, Illinois 60640
Contact:
773-275-3500
773-275-3500
AMR Clinical
Niles, Illinois 60714
Niles, Illinois 60714
IU Health Bloomington
Bloomington, Indiana 47408
Bloomington, Indiana 47408
Indiana University Health Methodist Hospital
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Tulane University School of Medicine
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Contact:
504-756-5621
504-756-5621
MaineHealth Cardiology
Scarborough, Maine 04074
Scarborough, Maine 04074
Ascension Saint Agnes Heart Care
Baltimore, Maryland 21229
Baltimore, Maryland 21229
Contact:
443-798-2670
443-798-2670
Metropolitan Cardiovascular Consultants
Beltsville, Maryland 20750
Beltsville, Maryland 20750
Contact:
301-595-0356
301-595-0356
Flourish Research - Bowie
Bowie, Maryland 20715
Bowie, Maryland 20715
Contact:
410-824-1342
410-824-1342
Johns Hopkins University
Columbia, Maryland 21044
Columbia, Maryland 21044
Centennial Medical Group
Columbia, Maryland 21045
Columbia, Maryland 21045
Contact:
410-730-3399
410-730-3399
Anderson Medical Research
Ft. Washington, Maryland 20744
Ft. Washington, Maryland 20744
Contact:
301-542-6741
301-542-6741
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Contact:
617-732-4245
617-732-4245
Lucida Clinical Trials
New Bedford, Massachusetts 02740
New Bedford, Massachusetts 02740
Care Access - Quincy
Quincy, Massachusetts 02169
Quincy, Massachusetts 02169
Contact:
877-791-0656
877-791-0656
Revival Research Institute, LLC
Dearborn, Michigan 48126
Dearborn, Michigan 48126
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Troy, Michigan 48098
Contact:
248-312-0025
248-312-0025
Boeson Research MSO
Missoula, Montana 59804
Missoula, Montana 59804
Contact:
406-763-8833
406-763-8833
Clinical Research of South Nevada
Las Vegas, Nevada 89121
Las Vegas, Nevada 89121
Contact:
702-570-6107
702-570-6107
Vector Clinical Trials
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Contact:
702-750-000
702-750-000
Vector Clinical Trials
Sparks, Nevada 89436
Sparks, Nevada 89436
Contact:
775-877-9777
775-877-9777
Clinical Research of Philadelphia
Pennington, New Jersey 08534
Pennington, New Jersey 08534
Contact:
215-676-6696
215-676-6696
Cardio Metabolic Institute
Somerset, New Jersey 08873
Somerset, New Jersey 08873
Contact:
732-846-7000 x 108
732-846-7000 x 108
IMA Clinical Research
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Contact:
505-848-3773
505-848-3773
Southwest Cardiovascular Center
Albuquerque, New Mexico 87112
Albuquerque, New Mexico 87112
Capital Cardiology Associates
Albany, New York 12211
Albany, New York 12211
Contact:
518-292-6216
518-292-6216
NYC Research
New York, New York 10016
New York, New York 10016
Contact:
516-574-9232
516-574-9232
Weill Cornell Medical College
New York, New York 10021
New York, New York 10021
Contact:
646-962-5558
646-962-5558
Rochester Clinical Research, LLC
Rochester, New York 14609
Rochester, New York 14609
Contact:
585-288-0890
585-288-0890
Southgate Medical Group
West Seneca, New York 14224
West Seneca, New York 14224
Contact:
716-712-1004
716-712-1004
Care Access - Fayetteville
Fayetteville, North Carolina 28314
Fayetteville, North Carolina 28314
Contact:
910-249-9855
910-249-9855
Medication Management
Greensboro, North Carolina 27405
Greensboro, North Carolina 27405
Contact:
336-763-6968
336-763-6968
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Advanced Research Institute - Tigard
Tigard, Oregon 97223
Tigard, Oregon 97223
Contact:
503-610-0033
503-610-0033
Capital Area Research, LLC
Camp Hill, Pennsylvania 17011
Camp Hill, Pennsylvania 17011
Contact:
717-441-1725
717-441-1725
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
Duncansville, Pennsylvania 16635
Contact:
814-693-0300
814-693-0300
Clinical Research of Philadelphia
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19114
Contact:
215-676-6696
215-676-6696
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania 19462
Plymouth Meeting, Pennsylvania 19462
Contact:
610-277-8073
610-277-8073
M3 Wake Research - Charleston
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Contact:
843-258-1852
843-258-1852
Walker Family Care
Little River, South Carolina 29566
Little River, South Carolina 29566
Contact:
843-280-8333
843-280-8333
Circle Clinical Research
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Contact:
605-215-1159
605-215-1159
WR-Clinsearch, LLC
Chattanooga, Tennessee 37397
Chattanooga, Tennessee 37397
Contact:
423-698-4584
423-698-4584
The Jackson Clinic
Jackson, Tennessee 38305
Jackson, Tennessee 38305
Contact:
731-660-8396
731-660-8396
PharmaTex Research
Amarillo, Texas 79106
Amarillo, Texas 79106
Contact:
806-355-2581
806-355-2581
St. David's Heart & Vascular PLLC dba Austin Heart
Austin, Texas 78756
Austin, Texas 78756
Southwest Family Medicine Associates
Dallas, Texas 75235
Dallas, Texas 75235
Contact:
469-893-1242
469-893-1242
Renal Disease Research Institute
Dallas, Texas 75246
Dallas, Texas 75246
Contact:
214-366-6125
214-366-6125
IntraCare
Dallas, Texas 75254
Dallas, Texas 75254
Contact:
972-385-0000
972-385-0000
UT Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Texas Health Research & Education Institute - Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Contact:
817-252-5000
817-252-5000
Cedar Health Research - Fort Worth
Fort Worth, Texas 76132
Fort Worth, Texas 76132
Contact:
214-253-8170
214-253-8170
Research Physicians Network, LLC
Houston, Texas 77089
Houston, Texas 77089
Contact:
281-944-3610
281-944-3610
GMG Clinical Research (DBA Radiance Clinical Research) - Lampasas
Lampasas, Texas 76550
Lampasas, Texas 76550
Contact:
512-556-4130
512-556-4130
Biopharma Informatic, LLC
McAllen, Texas 78503
McAllen, Texas 78503
Contact:
281-944-3610
281-944-3610
Revival Research Institute, LLC
McKinney, Texas 75071
McKinney, Texas 75071
PRX Research
Mesquite, Texas 75149
Mesquite, Texas 75149
Contact:
972-777-4428
972-777-4428
ERA Health Research-Texas
Midland, Texas 79707
Midland, Texas 79707
Contact:
432-528-7555
432-528-7555
Sherman Clinical Research
Sherman, Texas 75090
Sherman, Texas 75090
Contact:
903-771-4093
903-771-4093
Ogden Clinic - Canyon View
Ogden, Utah 84404
Ogden, Utah 84404
Contact:
385-271-0684
385-271-0684
Advanced Research Institute
Ogden, Utah 84405
Ogden, Utah 84405
Contact:
801-409-2040
801-409-2040
Virginia Heart
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Contact:
703-766-5920
703-766-5920
Carient Heart & Vascular - Manassas
Manassas, Virginia 20109
Manassas, Virginia 20109
Contact:
703-335-8750
703-335-8750
Manassas Clinical Research Center
Manassas, Virginia 20110
Manassas, Virginia 20110
Contact:
703-330-1112
703-330-1112
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News, Virginia 23606
Newport News, Virginia 23606
Contact:
757-232-8836
757-232-8836
York Clinical Research
Norfolk, Virginia 23504
Norfolk, Virginia 23504
Contact:
757-373-8478
757-373-8478
Dominion Medical Associates, Inc.
Richmond, Virginia 23219
Richmond, Virginia 23219
Contact:
804-249-2111
804-249-2111
Carilion Clinic
Roanoke, Virginia 24014
Roanoke, Virginia 24014
ERA Health Research - CardioNow - Lynnwood
Lynnwood, Washington 98036
Lynnwood, Washington 98036
Contact:
425-869-6828
425-869-6828
Eastside Research Associates
Redmond, Washington 98052
Redmond, Washington 98052
Contact:
425-869-6828
425-869-6828
Rainier Clinical Research Center
Renton, Washington 98057
Renton, Washington 98057
Contact:
425-251-1722
425-251-1722
Universal Research Group
Tacoma, Washington 98405
Tacoma, Washington 98405
Contact:
253-882-1070
253-882-1070
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington 98801
Wenatchee, Washington 98801
Contact:
509-436-4050
509-436-4050
Clinical Investigation Specialists
Kenosha, Wisconsin 53144
Kenosha, Wisconsin 53144
Contact:
262-925-1280
262-925-1280
Advanced Clinical Research, LLC
Bayamón, Puerto Rico 00959
Bayamón, Puerto Rico 00959
Contact:
7872696590
7872696590
Investigadores del Este
Humacao, Puerto Rico 00791
Humacao, Puerto Rico 00791
Contact:
787-409-8277
787-409-8277
Research and Cardiovascular Corp.
Ponce, Puerto Rico 00717
Ponce, Puerto Rico 00717
Contact:
787-290-8585
787-290-8585
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com