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)
Purpose
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.
Conditions
- Atherosclerotic Cardiovascular Disease (ASCVD)
- Elevated Lp(a)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
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 Lepodisiran Sodium |
Lepodisiran sodium administered subcutaneously (SC). |
|
Placebo Comparator Placebo |
Placebo administered SC. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35209
205-870-4343
Daphne 4058219, Alabama 4829764 36526
251-901-2111
Dothan 4059102, Alabama 4829764 36305
334-699-1632
Mobile 4076598, Alabama 4829764 36608
251-414-1984
Mobile 4076598, Alabama 4829764 36608
251-433-4700
Gilbert 5295903, Arizona 5551752 85296
480-691-2213
Gilbert 5295903, Arizona 5551752 85297
602-214-0886
Glendale 5295985, Arizona 5551752 85304
Phoenix 5308655, Arizona 5551752 85018
602-788-3437
Phoenix 5308655, Arizona 5551752 85028
480-372-5996
Phoenix 5308655, Arizona 5551752 85051
Sun City West 5316205, Arizona 5551752 85375
623-293-1360
Tucson 5318313, Arizona 5551752 85741
717-615-0659
Tucson 5318313, Arizona 5551752 85741
Tucson 5318313, Arizona 5551752 85745
520-647-9926
Little Rock 4119403, Arkansas 4099753 72204
501-664-0941
Beverly Hills 5328041, California 5332921 90211
310-289-9955
Covina 5340175, California 5332921 91723
626-598-4952
Escondido 5346827, California 5332921 92025
760-737-6984
Fountain Valley 5350207, California 5332921 92708
657-356-1300
Huntington Beach 5358705, California 5332921 92648
714-378-2440
Inglewood 5359488, California 5332921 90301
La Jolla 5363943, California 5332921 92037-7410
858-246-2510
La Jolla 5363943, California 5332921 92037
858-336-4314
Lancaster 5364940, California 5332921 93534
661-948-6011
Long Beach 5367929, California 5332921 90806
Long Beach 5367929, California 5332921 90815
562-997-1000
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90210
Northridge 5377985, California 5332921 91325
818-678-4900
Palm Springs 5380668, California 5332921 92262
760-320-9505
San Diego 5391811, California 5332921 92103
858-278-3647
Santa Clarita 5393049, California 5332921 91321
661-371-7272
Stanford 5398563, California 5332921 94305
650-723-3141
Sylmar 5400784, California 5332921 91342
Thousand Oaks 5402405, California 5332921 91360
805-778-5143
Toluca Lake 13157336, California 5332921 91602
Torrance 5403022, California 5332921 90502
310-222-1202
Torrance 5403022, California 5332921 90505
Van Nuys 5405693, California 5332921 91405
859-509-0084
West Hills 8030162, California 5332921 91307
818-702-8800
Westlake Village 5408395, California 5332921 91361
805-496-3322
Aurora 5412347, Colorado 5417618 80045
303-724-4651
Bridgeport 5282804, Connecticut 4831725 06610
203-384-4849
Hartford 4835797, Connecticut 4831725 06102
860-972-1695
Stamford 4843564, Connecticut 4831725 06905
203-353-1133
Waterbury 4845193, Connecticut 4831725 06708
203-419-4420
Washington D.C. 4140963, District of Columbia 4138106 20010
202-877-5975
Boca Raton 4148411, Florida 4155751 33434
Clearwater 4151316, Florida 4155751 33756
727-467-9393
Clearwater 4151316, Florida 4155751 33765
727-466-0078
Fort Lauderdale 4155966, Florida 4155751 33312
954-963-7100
Hialeah 4158476, Florida 4155751 33013
305-696-0331
Jacksonville 4160021, Florida 4155751 32205
904-693-1490
Jacksonville 4160021, Florida 4155751 32216
904-730-0101
Largo 4161580, Florida 4155751 33777
727-451-0523
Maitland 4163220, Florida 4155751 32751
407-810-2790
Margate 4163407, Florida 4155751 33063
954-582-7007
Miami 4164138, Florida 4155751 33135
305-631-6704
Miami Lakes 4164186, Florida 4155751 33014
786-502-4303
Naples 4165565, Florida 4155751 34102
239-230-2021
Ocala 4166673, Florida 4155751 34470
352-629-5800
Orlando 4167147, Florida 4155751 32806
407-816-5700 ext 1044
Orlando 4167147, Florida 4155751 32825
407-658-0966
Port Charlotte 4169130, Florida 4155751 33952
941-505-2100
Port Charlotte 4169130, Florida 4155751 33952
941-629-5356
Port Orange 4169156, Florida 4155751 32127
386-304-7070
Safety Harbor 4170797, Florida 4155751 34695
727-467-9393
Tamarac 4174738, Florida 4155751 33321
877-791-0656
Tampa 4174757, Florida 4155751 33606
813-870-1292
Tampa 4174757, Florida 4155751 33625
813-771-5980
Wellington 4177703, Florida 4155751 33449
561-537-4778
Acworth 4179074, Georgia 4197000 30101
Atlanta 4180439, Georgia 4197000 30303
Atlanta 4180439, Georgia 4197000 30318
Atlanta 4180439, Georgia 4197000 30322
404-727-3655
Augusta 4180531, Georgia 4197000 30904
706-922-3005
Canton 4186213, Georgia 4197000 30114
678-785-9600
Douglasville 4191955, Georgia 4197000 30134
Gainesville 4196586, Georgia 4197000 30501
770-534-5154
Lawrenceville 4205196, Georgia 4197000 30044
678-822-5581
Macon 4207400, Georgia 4197000 31210
478-219-2017
Woodstock 4231874, Georgia 4197000 30189
678-494-5735
Meridian 5600685, Idaho 5596512 83642
Chicago 4887398, Illinois 4896861 60607
312-791-3241
Chicago 4887398, Illinois 4896861 60640
773-275-3500
Gurnee 4894861, Illinois 4896861 60031
847-599-2492
Park Ridge 4905367, Illinois 4896861 60068
Springfield 4250542, Illinois 4896861 62711
217-546-2064
Winfield 4916826, Illinois 4896861 60190
630-933-8100
Avon 4254021, Indiana 4921868 46123
317-745-8000
Franklin 4828382, Indiana 4921868 46131
317-738-7400
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46227
463-234-1010
West Des Moines 4881346, Iowa 4862182 50266
515-329-6800
Topeka 4280539, Kansas 4273857 66606
785-354-9591
Wichita 4281730, Kansas 4273857 67207
316-689-6665
Bowling Green 4285268, Kentucky 6254925 42101
270-685-4589
Lexington 4297983, Kentucky 6254925 40509
859-264-8999
Bossier City 4317639, Louisiana 4331987 71111
318-638-7309
Lake Charles 4330236, Louisiana 4331987 70601
337-602-6642
Monroe 4333669, Louisiana 4331987 71201
318-737-1098
Slidell 4341727, Louisiana 4331987 70458
985-649-2700
Baltimore 4347778, Maryland 4361885 21209
410-367-2590
Baltimore 4347778, Maryland 4361885 21213
877-791-0656
Baltimore 4347778, Maryland 4361885 21229
443-798-2670
Baltimore 4347778, Maryland 4361885 21239
443-444-6275
Beltsville 4348353, Maryland 4361885 20705
301-595-0356
Bowie 4349159, Maryland 4361885 20715
410-824-1342
Columbia 4352053, Maryland 4361885 21045
410-964-6115
Ft. Washington 4355355, Maryland 4361885 20744
301-542-6741
Hyattsville 4358821, Maryland 4361885 20782
443-444-5663
Boston 4930956, Massachusetts 6254926 02115
617-732-4245
Fall River 4936159, Massachusetts 6254926 02721
508-672-7450
Quincy 4948247, Massachusetts 6254926 02169
877-791-0656
Dearborn 4990510, Michigan 5001836 48126
313-887-3090
Dearborn 4990510, Michigan 5001836 48126
Detroit 4990729, Michigan 5001836 48202
313-737-6295
Troy 5012639, Michigan 5001836 48098
248-312-0025
Ypsilanti 5015688, Michigan 5001836 48197
Diamondhead 4423888, Mississippi 4436296 39525
City of Saint Peters 4407237, Missouri 4398678 63303
636-387-5100
Springfield 4409896, Missouri 4398678 65807
417-883-7889
Butte 5642934, Montana 5667009 59701
406-723-1375
Henderson 5505411, Nevada 5509151 89074
702-605-5750
Las Vegas 5506956, Nevada 5509151 89107
702-877-1887
Las Vegas 5506956, Nevada 5509151 89128
702-736-5161
Las Vegas 5506956, Nevada 5509151 89128
702-750-0000
Bridgeton 4500942, New Jersey 5101760 08302
856-455-4500
Somerset 5104755, New Jersey 5101760 08873
732-846-7000 x 108
Summit 5105127, New Jersey 5101760 07901
973-467-0005
Warren Township 8299577, New Jersey 5101760 07059
Albuquerque 5454711, New Mexico 5481136 87109
505-848-3773
Albany 5106834, New York 5128638 12203
518-264-4420
Lake Success 5123853, New York 5128638 11042
516-627-2121
New York 5128581, New York 5128638 10016
212-263-3166
New York 5128581, New York 5128638 10016
212-263-4300
New York 5128581, New York 5128638 10029
212-241-9101
New York 5128581, New York 5128638 10036
646-722-6214
New York 5128581, New York 5128638 10075
212-434-6160
Riverhead 5133926, New York 5128638 11901
631-702-8937
Rochester 5134086, New York 5128638 14642
585-275-3356
Saratoga Springs 5136334, New York 5128638 12866
518-693-0186
Stony Brook 5139865, New York 5128638 11794
631-263-3531
Fayetteville 4466033, North Carolina 4482348 28314
910-249-9855
Greensboro 4469146, North Carolina 4482348 27405
336-763-6968
Greensboro 4469146, North Carolina 4482348 27410
336-235-0991
Greenville 4469160, North Carolina 4482348 27834
252-413-6683
Mount Airy 4480378, North Carolina 4482348 27030
336-415-5507
Raleigh 4487042, North Carolina 4482348 27609
919-783-4895
Wilmington 4499379, North Carolina 4482348 28401
910-815-6108
Winston-Salem 4499612, North Carolina 4482348 27157
Beachwood 5146711, Ohio 5165418 44122
216-682-0320
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45246
513-671-8080
Cleveland 5150529, Ohio 5165418 44195
216-445-0224
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43213
614-501-6164
Corvallis 5720727, Oregon 5744337 97330
Allentown 5178127, Pennsylvania 6254927 18103
610-402-9543
Beaver 5179446, Pennsylvania 6254927 15009
724-770-0935
Camp Hill 5182928, Pennsylvania 6254927 17011
717-441-1725
Horsham 5194302, Pennsylvania 6254927 19044
215-517-1000
Lancaster 5197079, Pennsylvania 6254927 17602
717-544-8300
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19114
215-676-6696
Pittsburgh 5206379, Pennsylvania 6254927 15212
Plymouth Meeting 5206666, Pennsylvania 6254927 19462
610-277-8073
Uniontown 4561859, Pennsylvania 6254927 15401
724-438-1479
Yardley 5220281, Pennsylvania 6254927 19067
215-321-7400
York 4562407, Pennsylvania 6254927 17403
Charleston 4574324, South Carolina 4597040 29456
843-849-1880
Greenville 4580543, South Carolina 4597040 29607
864-334-0141
Little River 4585421, South Carolina 4597040 29566
843-280-8333
Mauldin 4586523, South Carolina 4597040 29662
864-202-6290
Mt. Pleasant 4588165, South Carolina 4597040 29464
843-849-1880
Rapid City 5768233, South Dakota 5769223 57701
605-755-4326
Knoxville 4634946, Tennessee 4662168 37909
865-305-9100 x246
Memphis 4641239, Tennessee 4662168 38119
901-593-1462
Amarillo 5516233, Texas 4736286 79106
806-355-2581
Amarillo 5516233, Texas 4736286 79124
806-463-2153
Austin 4671654, Texas 4736286 78745
512-649-0082
Austin 4671654, Texas 4736286 78759
512-506-8287
Brownsville 4676740, Texas 4736286 78526
Corpus Christi 4683416, Texas 4736286 78404
361-288-4668
Dallas 4684888, Texas 4736286 75224
214-467-3832
Dallas 4684888, Texas 4736286 75226
214-820-2273
Dallas 4684888, Texas 4736286 75230
Dallas 4684888, Texas 4736286 75251
214-253-8170
Dallas 4684888, Texas 4736286 75390
Denison 4685892, Texas 4736286 75020
Edinburg 4688275, Texas 4736286 78539
Fort Worth 4691930, Texas 4736286 76104
817-252-5000
Houston 4699066, Texas 4736286 77030
713-798-5800
Houston 4699066, Texas 4736286 77040
713-779-5494
Houston 4699066, Texas 4736286 77043
281-944-3610
Houston 4699066, Texas 4736286 77079
713-973-3415
Houston 4699066, Texas 4736286 77089
281-944-3610
Humble 4699442, Texas 4736286 77338
281-760-3930
Lufkin 4708308, Texas 4736286 75904
936-249-6489
McAllen 4709796, Texas 4736286 78503
281-944-3610
McKinney 4710178, Texas 4736286 75069
972-900-3538
McKinney 4710178, Texas 4736286 75071
9 - 5
McKinney 4710178, Texas 4736286 75071
214-544-7555
Mesquite 4710826, Texas 4736286 75149
972-777-4428
Mesquite 4710826, Texas 4736286 75149
214-693-0904
San Antonio 4726206, Texas 4736286 78212
210-223-4444
San Antonio 4726206, Texas 4736286 78229
210-949-0122
San Antonio 4726206, Texas 4736286 78229
210-692-7157
San Antonio 4726206, Texas 4736286 78240
518-428-6859
Shavano Park 4728147, Texas 4736286 78231
210-545-4900
Shenandoah 4728287, Texas 4736286 77384
346-334-7390
Sherman 4728328, Texas 4736286 75090
903-771-4093
Sherman 4728328, Texas 4736286 75092
Clinton 5773001, Utah 5549030 84015
801-791-2206
Murray 5778755, Utah 5549030 84107
801-507-4707
Falls Church 4758390, Virginia 6254928 22042
703-766-5920
Norfolk 4776222, Virginia 6254928 23502
757-627-7446
Redmond 5808079, Washington 5815135 98052
425-869-6828
Morgantown 4815352, West Virginia 4826850 26505
304-408-3281
Kenosha 5258393, Wisconsin 5279468 53144
262-925-1280
Bayamón 4562831, Puerto Rico 00959
7872696590
San Juan 4568127, Puerto Rico 00917
7879362100
More Details
- NCT ID
- NCT06292013
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or317-615-4559
clinical_inquiry_hub@lilly.com