The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Purpose
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
Conditions
- Atherosclerotic Cardiovascular Disease (ASCVD)
- Chronic Kidney Disease (CKD)
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower - Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following: - Coronary artery disease - Cerebrovascular disease - Peripheral arterial disease - Chronic kidney disease defined as: - eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg) - eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or - eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab) - A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
Exclusion Criteria
Diabetes related: - Participants have Type 1 Diabetes or any history of diabetic ketoacidosis CV related: - Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization: - Myocardial infarction - Acute coronary syndrome - Stroke, or - Coronary, peripheral, or carotid artery arterial revascularization procedure. - Have acute decompensated heart failure requiring hospitalization. - Have New York Heart Association (NYHA) Classification Class IV heart failure at screening Kidney related: - Participants have an eGFR <20 mL/min/1.73 m^2 at screening - Have UACR >5000 mg/g (5.000 mg/mg) at screening - Have received any form of dialysis ≤ 90 days from the date of randomization - Have either undergone a kidney transplant or have a transplant procedure scheduled Other medical conditions: - Participants have had or plan to have a surgical treatment for obesity, - Have a history of chronic or acute pancreatitis - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2 - Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction
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 Retatrutide |
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose. |
|
Placebo Comparator Placebo |
Participants will receive matching placebo administered SC. |
|
Recruiting Locations
Alabaster 4829762, Alabama 4829764 35007
Birmingham 4049979, Alabama 4829764 35205
205-327-1077
Daphne 4058219, Alabama 4829764 36526
251-901-2111
Huntsville 4068590, Alabama 4829764 35805
256-533-4626
Mobile 4076598, Alabama 4829764 36608
251-414-1984
Gilbert 5295903, Arizona 5551752 85296
480-691-2213
Glendale 5295985, Arizona 5551752 85304
Glendale 5295985, Arizona 5551752 85306
602-228-4080
Paradise Valley 5308049, Arizona 5551752 85253
480-535-6589
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85014
Phoenix 5308655, Arizona 5551752 85016
602-456-2342
Phoenix 5308655, Arizona 5551752 85018
602-788-3437
Phoenix 5308655, Arizona 5551752 85051
Scottsdale 5313457, Arizona 5551752 85260
480-382-7909
Sun City West 5316205, Arizona 5551752 85375
623-293-1360
Tucson 5318313, Arizona 5551752 85741
Little Rock 4119403, Arkansas 4099753 72204
501-664-0941
Apple Valley 5324363, California 5332921 92307
760-780-4179
Bakersfield 5325738, California 5332921 93309
Beverly Hills 5328041, California 5332921 90211
213-481-7142
Canoga Park 5333913, California 5332921 91303
818-999-4676
Covina 5340175, California 5332921 91723
626-598-4952
Encinitas 5346646, California 5332921 92024
760-434-6060
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
Irvine 5359777, California 5332921 92614
949-753-1663
La Jolla 5363943, California 5332921 92037
858-824-5352
Long Beach 5367929, California 5332921 90805
Long Beach 5367929, California 5332921 90815
562-997-1000
Lynwood 5369367, California 5332921 90262
Northridge 5377985, California 5332921 91325
818-280-4220
Palm Springs 5380668, California 5332921 92262
760-320-9505
Pasadena 5381396, California 5332921 91105
626-795-5769
Pomona 5384170, California 5332921 91766
909-469-8626
San Dimas 5391891, California 5332921 91773
Santa Ana 5392900, California 5332921 92701
714-474-2173
Santa Clarita 5393049, California 5332921 91321
661-371-7272
Spring Valley 5398277, California 5332921 91978
619-660-9068
Tarzana 5401143, California 5332921 91356
818-938-9167
Thousand Oaks 5402405, California 5332921 91360
805-778-5143
Toluca Lake 13157336, California 5332921 91602
Torrance 5403022, California 5332921 90502
310-974-9334
Torrance 5403022, California 5332921 90505
Van Nuys 5405693, California 5332921 91405
859-509-0084
Victorville 5406222, California 5332921 92392
760-995-4918
Westlake Village 5408395, California 5332921 91361
805-496-3322
Arvada 5412199, Colorado 5417618 80002
303-232-3366
Aurora 5412347, Colorado 5417618 80045
303-724-4651
Stamford 4843564, Connecticut 4831725 06905
Waterbury 4845193, Connecticut 4831725 06708
203-419-4420
Boca Raton 4148411, Florida 4155751 33434
561-756-8206
Cutler Bay 6332309, Florida 4155751 33157
Fleming Island 4155594, Florida 4155751 32003
904-621-0390
Fort Lauderdale 4155966, Florida 4155751 33312
954-963-7100
Fort Lauderdale 4155966, Florida 4155751 33316
954-463-0112
Jacksonville 4160021, Florida 4155751 32216
904-854-1354
Leesburg 4161771, Florida 4155751 34748
352-782-0606
Miami 4164138, Florida 4155751 33135
305-631-6704
Miami 4164138, Florida 4155751 33186
305-596-9901
Miami 4164138, Florida 4155751 33186
Miami Lakes 4164186, Florida 4155751 33014
786-502-4303
Orlando 4167147, Florida 4155751 32806
407-816-5700 ext 1044
Orlando 4167147, Florida 4155751 32808
407-988-1075
Port Charlotte 4169130, Florida 4155751 33952
941-505-8720
Riverview 4170156, Florida 4155751 33578
Sarasota 4172131, Florida 4155751 34239
941-366-9800
Tamarac 4174738, Florida 4155751 33321
877-791-0656
Tampa 4174757, Florida 4155751 33609
813-948-7550
Tampa 4174757, Florida 4155751 33625
813-771-5980
Acworth 4179074, Georgia 4197000 30101
Atlanta 4180439, Georgia 4197000 30318
Atlanta 4180439, Georgia 4197000 30322
404-727-3655
Atlanta 4180439, Georgia 4197000 30342
678-883-6897
Augusta 4180531, Georgia 4197000 30904
706-922-3005
Douglasville 4191955, Georgia 4197000 30134
Gainesville 4196586, Georgia 4197000 30501
770-534-5154
Macon 4207400, Georgia 4197000 31210
478-219-2017
Woodstock 4231874, Georgia 4197000 30189
678-494-5735
Chicago 4887398, Illinois 4896861 60640
316-258-0060
Gurnee 4894861, Illinois 4896861 60031
847-599-2492
Hinsdale 4896012, Illinois 4896861 60521
Lombard 4900373, Illinois 4896861 60148
630-627-4722
Park Ridge 4905367, Illinois 4896861 60068
Rockford 4907959, Illinois 4896861 61107
Springfield 4250542, Illinois 4896861 62711
217-546-2064
Evansville 4257227, Indiana 4921868 47715
812-205-2475
Fort Wayne 4920423, Indiana 4921868 46804
260-341-4415
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46227
463-234-1010
Indianapolis 4259418, Indiana 4921868 46227
Richmond 4263681, Indiana 4921868 47374
765-962-1337
West Des Moines 4881346, Iowa 4862182 50266
515-329-6800
Fairway 4271358, Kansas 4273857 66205
Newton 4276248, Kansas 4273857 67114
316-804-7304
Topeka 4280539, Kansas 4273857 66606
785-354-9591
Topeka 4280539, Kansas 4273857 66606
785-354-9591
Bowling Green 4285268, Kentucky 6254925 42101
270-685-4589
Lexington 4297983, Kentucky 6254925 40509
859-264-8999
Louisville 4299276, Kentucky 6254925 40213
502-515-5672
Lake Charles 4330236, Louisiana 4331987 70601
337-602-6642
Monroe 4333669, Louisiana 4331987 71201
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
Ft. Washington 4355355, Maryland 4361885 20744
301-542-6741
Hyattsville 4358821, Maryland 4361885 20782
443-444-5663
Fall River 4936159, Massachusetts 6254926 02721
508-672-7450
Quincy 4948247, Massachusetts 6254926 02169
877-791-0656
Dearborn 4990510, Michigan 5001836 48126
Pontiac 5006166, Michigan 5001836 48341
248-253-0330
Saint Joseph 5008327, Michigan 5001836 49085
Southfield 5010636, Michigan 5001836 48075
248-864-5242
Troy 5012639, Michigan 5001836 48098
248-312-0025
City of Saint Peters 4407237, Missouri 4398678 63303
636-387-5100
Kansas City 4393217, Missouri 4398678 64114
Springfield 4409896, Missouri 4398678 65807
417-883-7889
Butte 5642934, Montana 5667009 59701
406-723-1375
Missoula 5666639, Montana 5667009 59804
406-763-8833
Henderson 5505411, Nevada 5509151 89052
Las Vegas 5506956, Nevada 5509151 89107
702-877-1887
Las Vegas 5506956, Nevada 5509151 89109
702-680-1500
Las Vegas 5506956, Nevada 5509151 89119
702-597-9825
Las Vegas 5506956, Nevada 5509151 89123
702-898-2088
Las Vegas 5506956, Nevada 5509151 89128
702-750-0000
Albany 5106834, New York 5128638 12203
518-264-4420
Albany 5106834, New York 5128638 12211
518-292-6216
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 10029
212-241-9101
Saratoga Springs 5136334, New York 5128638 12866
518-693-0186
Fayetteville 4466033, North Carolina 4482348 28314
910-249-9855
Greensboro 4469146, North Carolina 4482348 27405
336-763-6968
Lenoir 4475640, North Carolina 4482348 28645
828-572-5080
Morehead City 4480153, North Carolina 4482348 28557
252-515-0050
Raleigh 4487042, North Carolina 4482348 27609
919-783-4895
Wilmington 4499379, North Carolina 4482348 28401
910-815-6108
Maumee 5162137, Ohio 5165418 43537
419-866-6300
Norman 4543762, Oklahoma 4544379 73069
405-701-8999
Beaver 5179446, Pennsylvania 6254927 15009
724-770-0935
Bethlehem 5180225, Pennsylvania 6254927 18017
610-433-4100
Camp Hill 5182928, Pennsylvania 6254927 17011
717-441-1725
Danville 5186327, Pennsylvania 6254927 17822
Lancaster 5197079, Pennsylvania 6254927 17602
Philadelphia 4560349, Pennsylvania 6254927 19114
215-676-6696
Philadelphia 4560349, Pennsylvania 6254927 19114
215-831-0445
Pittsburgh 5206379, Pennsylvania 6254927 15243
412-942-0023
Sayre 5211037, Pennsylvania 6254927 18840
Upland 4561874, Pennsylvania 6254927 19013
610-872-8501
Charleston 4574324, South Carolina 4597040 29425
843-792-5873
Ladson 4584277, South Carolina 4597040 29456
843-849-1880
Little River 4585421, South Carolina 4597040 29566
843-280-8333
Mauldin 4586523, South Carolina 4597040 29662
864-202-6290
Sioux Falls 5231851, South Dakota 5769223 57104
605-215-1159
Knoxville 4634946, Tennessee 4662168 37920
865-305-9100 x246
Memphis 4641239, Tennessee 4662168 38119
901-593-1462
Austin 4671654, Texas 4736286 78745
512-649-0082
Brownsville 4676740, Texas 4736286 78526
Corpus Christi 4683416, Texas 4736286 78404
361-288-4668
Corpus Christi 4683416, Texas 4736286 78414
361-885-0448
Dallas 4684888, Texas 4736286 75226
214-820-2273
Dallas 4684888, Texas 4736286 75230
Dallas 4684888, Texas 4736286 75231
469-364-6918
Dallas 4684888, Texas 4736286 75246
214-366-6125
Dallas 4684888, Texas 4736286 75390-9302
870-866-1669
Denison 4685892, Texas 4736286 75020
469-819-0228
Edinburg 4688275, Texas 4736286 78539
El Paso 5520993, Texas 4736286 79902-4646
915-307-4669
Fort Worth 4691930, Texas 4736286 76132
817-263-0007
Fort Worth 4691930, Texas 4736286 76164
817-625-7733
Houston 4699066, Texas 4736286 77040
713-779-5494
Houston 4699066, Texas 4736286 77043
281-944-3610
Houston 4699066, Texas 4736286 77058
281-939-6516
Houston 4699066, Texas 4736286 77070
949-491-0710
Houston 4699066, Texas 4736286 77074
713-484-6947
Houston 4699066, Texas 4736286 77079
713-973-3415
Houston 4699066, Texas 4736286 77084
281-944-3610
Houston 4699066, Texas 4736286 77089
281-944-3610
Humble 4699442, Texas 4736286 77346
281-760-3930
Lufkin 4708308, Texas 4736286 75904
936-632-4282
McKinney 4710178, Texas 4736286 75069
972-900-3538
Mesquite 4710826, Texas 4736286 75149
Mesquite 4710826, Texas 4736286 75149
214-693-0904
San Antonio 4726206, Texas 4736286 78212
210-223-4444
San Antonio 4726206, Texas 4736286 78229
210-591-1163
San Antonio 4726206, Texas 4736286 78229
210-692-7157
San Antonio 4726206, Texas 4736286 78240
518-428-6859
Shenandoah 4728287, Texas 4736286 77384
346-334-7390
Sherman 4728328, Texas 4736286 75092
Wylie 4743275, Texas 4736286 75098
469-449-3645
Clinton 5773001, Utah 5549030 84015
801-791-2206
Layton 5777107, Utah 5549030 84041
801-679-4153
Salt Lake City 5780993, Utah 5549030 84106
801-261-8930
Salt Lake City 5780993, Utah 5549030 84115
801-747-9186
Norfolk 4776222, Virginia 6254928 23502
757-627-7446
Richmond 4781708, Virginia 6254928 23219
804-249-2111
Redmond 5808079, Washington 5815135 98052
425-869-6828
Tacoma 5812944, Washington 5815135 98405
253-882-1070
Morgantown 4815352, West Virginia 4826850 26505
304-408-3281
Green Bay 5254962, Wisconsin 5279468 54303
920-272-3336
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
- NCT06383390
- 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) or1-317-615-4559
clinical_inquiry_hub@lilly.com