Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06383390




Registration number
NCT06383390
Ethics application status
Date submitted
22/04/2024
Date registered
25/04/2024
Date last updated
26/06/2024

Titles & IDs
Public title
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants With Body Mass Index =27 kg/m^2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease.
Secondary ID [1] 0 0
J1I-MC-GZBO
Secondary ID [2] 0 0
18584
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Retatrutide
Treatment: Drugs - Placebo

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.


Treatment: Drugs: Retatrutide
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Composite Endpoints
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Primary outcome [2] 0 0
Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), = 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death
Timepoint [2] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [1] 0 0
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [2] 0 0
Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF
Timepoint [2] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [3] 0 0
Time to Occurrence of All-Cause Death
Timepoint [3] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [4] 0 0
Time to First Occurrence of composite endpoint of = 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death
Timepoint [4] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [5] 0 0
Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR =30 mg/g (0.03 mg/mg) at baseline
Timepoint [5] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)

Eligibility
Key inclusion criteria
* A Body Mass Index of =27.0 kilograms per meter squared (kg/m^2)
* Participants may be with or without type 2 diabetes (T2D) unless 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)
* eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or
* eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes related:

* Participants have Type 1 Diabetes or 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 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2029
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Optimus Clinical Research - Botany
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [9] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [10] 0 0
Nightingale Research - Adelaide
Recruitment hospital [11] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [12] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [13] 0 0
Emeritus Research - Camberwell
Recruitment hospital [14] 0 0
Barwon Health - Geelong
Recruitment hospital [15] 0 0
Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [16] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [17] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2100 - Brookvale
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2291 - Merewether
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2006 - Sydney
Recruitment postcode(s) [8] 0 0
4029 - Brisbane
Recruitment postcode(s) [9] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
3124 - Camberwell
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [16] 0 0
3004 - Melbourne
Recruitment postcode(s) [17] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Ciudad Autónoma De Buenos Aires
Country [39] 0 0
Argentina
State/province [39] 0 0
Córdoba
Country [40] 0 0
Argentina
State/province [40] 0 0
La Pampa
Country [41] 0 0
Argentina
State/province [41] 0 0
Mendoza
Country [42] 0 0
Argentina
State/province [42] 0 0
Santa Fe
Country [43] 0 0
Argentina
State/province [43] 0 0
Tucumán
Country [44] 0 0
Argentina
State/province [44] 0 0
Santiago del Estero
Country [45] 0 0
Austria
State/province [45] 0 0
Oberösterreich
Country [46] 0 0
Austria
State/province [46] 0 0
Steiermark
Country [47] 0 0
Austria
State/province [47] 0 0
Tirol
Country [48] 0 0
Austria
State/province [48] 0 0
Vorarlberg
Country [49] 0 0
Austria
State/province [49] 0 0
Wien
Country [50] 0 0
Austria
State/province [50] 0 0
Vienna
Country [51] 0 0
Belgium
State/province [51] 0 0
Antwerpen
Country [52] 0 0
Belgium
State/province [52] 0 0
Bruxelles-Capitale, Région De
Country [53] 0 0
Belgium
State/province [53] 0 0
Limburg
Country [54] 0 0
Belgium
State/province [54] 0 0
Oost-Vlaanderen
Country [55] 0 0
Belgium
State/province [55] 0 0
Vlaams Gewest
Country [56] 0 0
Belgium
State/province [56] 0 0
Vlaams-Brabant
Country [57] 0 0
Belgium
State/province [57] 0 0
West-Vlaanderen
Country [58] 0 0
Belgium
State/province [58] 0 0
Liège
Country [59] 0 0
Brazil
State/province [59] 0 0
Alagoas
Country [60] 0 0
Brazil
State/province [60] 0 0
Amazonas
Country [61] 0 0
Brazil
State/province [61] 0 0
Bahia
Country [62] 0 0
Brazil
State/province [62] 0 0
Ceará
Country [63] 0 0
Brazil
State/province [63] 0 0
Distrito Federal
Country [64] 0 0
Brazil
State/province [64] 0 0
Espírito Santo
Country [65] 0 0
Brazil
State/province [65] 0 0
Goiás
Country [66] 0 0
Brazil
State/province [66] 0 0
Minas Gerais
Country [67] 0 0
Brazil
State/province [67] 0 0
Paraná
Country [68] 0 0
Brazil
State/province [68] 0 0
Pará
Country [69] 0 0
Brazil
State/province [69] 0 0
Rio Grande Do Sul
Country [70] 0 0
Brazil
State/province [70] 0 0
Santa Catarina
Country [71] 0 0
Brazil
State/province [71] 0 0
Sergipe
Country [72] 0 0
Brazil
State/province [72] 0 0
São Paulo
Country [73] 0 0
Brazil
State/province [73] 0 0
Rio de Janeiro
Country [74] 0 0
Brazil
State/province [74] 0 0
Rio De Janeiro
Country [75] 0 0
Canada
State/province [75] 0 0
Alberta
Country [76] 0 0
Canada
State/province [76] 0 0
British Columbia
Country [77] 0 0
Canada
State/province [77] 0 0
Manitoba
Country [78] 0 0
Canada
State/province [78] 0 0
New Brunswick
Country [79] 0 0
Canada
State/province [79] 0 0
Nova Scotia
Country [80] 0 0
Canada
State/province [80] 0 0
Ontario
Country [81] 0 0
Canada
State/province [81] 0 0
Quebec
Country [82] 0 0
Czechia
State/province [82] 0 0
Brno-mesto
Country [83] 0 0
Czechia
State/province [83] 0 0
Jihomoravský Kraj
Country [84] 0 0
Czechia
State/province [84] 0 0
Královéhradecký Kraj
Country [85] 0 0
Czechia
State/province [85] 0 0
Moravskoslezský Kraj
Country [86] 0 0
Czechia
State/province [86] 0 0
Olomoucký Kraj
Country [87] 0 0
Czechia
State/province [87] 0 0
Ostrava Mesto
Country [88] 0 0
Czechia
State/province [88] 0 0
Plzen-jih
Country [89] 0 0
Czechia
State/province [89] 0 0
Praha 13
Country [90] 0 0
Czechia
State/province [90] 0 0
Praha 1
Country [91] 0 0
Czechia
State/province [91] 0 0
Praha 2
Country [92] 0 0
Czechia
State/province [92] 0 0
Praha 4
Country [93] 0 0
Czechia
State/province [93] 0 0
Praha 6
Country [94] 0 0
Czechia
State/province [94] 0 0
Praha 8
Country [95] 0 0
Czechia
State/province [95] 0 0
Praha 9
Country [96] 0 0
Czechia
State/province [96] 0 0
Praha, Hlavní Mešto
Country [97] 0 0
Czechia
State/province [97] 0 0
Praha-východ
Country [98] 0 0
Czechia
State/province [98] 0 0
Stredoceský Kraj
Country [99] 0 0
Czechia
State/province [99] 0 0
Zlínský Kraj
Country [100] 0 0
Czechia
State/province [100] 0 0
Náchod
Country [101] 0 0
Czechia
State/province [101] 0 0
Olomouc
Country [102] 0 0
Czechia
State/province [102] 0 0
Trutnov
Country [103] 0 0
Czechia
State/province [103] 0 0
Zlín
Country [104] 0 0
Czechia
State/province [104] 0 0
Ceský Krumlov
Country [105] 0 0
Denmark
State/province [105] 0 0
Hovedstaden
Country [106] 0 0
Denmark
State/province [106] 0 0
Midtjylland
Country [107] 0 0
Denmark
State/province [107] 0 0
Nordjylland
Country [108] 0 0
Denmark
State/province [108] 0 0
Syddanmark
Country [109] 0 0
France
State/province [109] 0 0
Alpes-Maritimes
Country [110] 0 0
France
State/province [110] 0 0
Aquitaine
Country [111] 0 0
France
State/province [111] 0 0
Eure-et-Loir
Country [112] 0 0
France
State/province [112] 0 0
Haute-Garonne
Country [113] 0 0
France
State/province [113] 0 0
Hérault
Country [114] 0 0
France
State/province [114] 0 0
Indre-et-Loire
Country [115] 0 0
France
State/province [115] 0 0
Isère
Country [116] 0 0
France
State/province [116] 0 0
Loire-Atlantique
Country [117] 0 0
France
State/province [117] 0 0
Nord
Country [118] 0 0
France
State/province [118] 0 0
Orne
Country [119] 0 0
France
State/province [119] 0 0
Puy-de-Dôme
Country [120] 0 0
France
State/province [120] 0 0
Île-de-France
Country [121] 0 0
Germany
State/province [121] 0 0
Baden-Württemberg
Country [122] 0 0
Germany
State/province [122] 0 0
Brandenburg
Country [123] 0 0
Germany
State/province [123] 0 0
Hessen
Country [124] 0 0
Germany
State/province [124] 0 0
Niedersachsen
Country [125] 0 0
Germany
State/province [125] 0 0
Nordrhein-Westfalen
Country [126] 0 0
Germany
State/province [126] 0 0
Rheinland-Pfalz
Country [127] 0 0
Germany
State/province [127] 0 0
Saarland
Country [128] 0 0
Germany
State/province [128] 0 0
Sachsen
Country [129] 0 0
Germany
State/province [129] 0 0
Schleswig-Holstein
Country [130] 0 0
Germany
State/province [130] 0 0
Berlin
Country [131] 0 0
Germany
State/province [131] 0 0
Bremen
Country [132] 0 0
Germany
State/province [132] 0 0
Hamburg
Country [133] 0 0
Greece
State/province [133] 0 0
Attikí (Region)
Country [134] 0 0
Greece
State/province [134] 0 0
Attikí
Country [135] 0 0
Greece
State/province [135] 0 0
Thessaloníki
Country [136] 0 0
Greece
State/province [136] 0 0
Thessalía
Country [137] 0 0
Greece
State/province [137] 0 0
Ípeiros
Country [138] 0 0
Hungary
State/province [138] 0 0
Csongrád
Country [139] 0 0
Hungary
State/province [139] 0 0
Jász-Nagykun-Szolnok
Country [140] 0 0
Hungary
State/province [140] 0 0
Komárom-Esztergom
Country [141] 0 0
Hungary
State/province [141] 0 0
Pest
Country [142] 0 0
Hungary
State/province [142] 0 0
Veszprém
Country [143] 0 0
Hungary
State/province [143] 0 0
Zala
Country [144] 0 0
Hungary
State/province [144] 0 0
Budapest
Country [145] 0 0
Hungary
State/province [145] 0 0
Debrecen
Country [146] 0 0
India
State/province [146] 0 0
Chhattisgarh
Country [147] 0 0
India
State/province [147] 0 0
Delhi
Country [148] 0 0
India
State/province [148] 0 0
Gujarat
Country [149] 0 0
India
State/province [149] 0 0
Karnataka
Country [150] 0 0
India
State/province [150] 0 0
Kerala
Country [151] 0 0
India
State/province [151] 0 0
Maharashtra
Country [152] 0 0
India
State/province [152] 0 0
Odisha
Country [153] 0 0
India
State/province [153] 0 0
Tamil Nadu
Country [154] 0 0
India
State/province [154] 0 0
Uttar Pradesh
Country [155] 0 0
India
State/province [155] 0 0
Uttarakhand
Country [156] 0 0
Israel
State/province [156] 0 0
HaDarom
Country [157] 0 0
Israel
State/province [157] 0 0
HaMerkaz
Country [158] 0 0
Israel
State/province [158] 0 0
HaTsafon
Country [159] 0 0
Israel
State/province [159] 0 0
Tell Abib
Country [160] 0 0
Israel
State/province [160] 0 0
Yerushalayim
Country [161] 0 0
Italy
State/province [161] 0 0
Emilia-Romagna
Country [162] 0 0
Italy
State/province [162] 0 0
Liguria
Country [163] 0 0
Italy
State/province [163] 0 0
Milano
Country [164] 0 0
Italy
State/province [164] 0 0
Roma
Country [165] 0 0
Italy
State/province [165] 0 0
Sicilia
Country [166] 0 0
Italy
State/province [166] 0 0
Toscana
Country [167] 0 0
Italy
State/province [167] 0 0
Umbria
Country [168] 0 0
Italy
State/province [168] 0 0
Bergamo
Country [169] 0 0
Italy
State/province [169] 0 0
Bologna
Country [170] 0 0
Mexico
State/province [170] 0 0
Baja California
Country [171] 0 0
Mexico
State/province [171] 0 0
Distrito Federal
Country [172] 0 0
Mexico
State/province [172] 0 0
Guanajuato
Country [173] 0 0
Mexico
State/province [173] 0 0
Hidalgo
Country [174] 0 0
Mexico
State/province [174] 0 0
Jalisco
Country [175] 0 0
Mexico
State/province [175] 0 0
Michoacán
Country [176] 0 0
Mexico
State/province [176] 0 0
Morelos
Country [177] 0 0
Mexico
State/province [177] 0 0
Nuevo León
Country [178] 0 0
Mexico
State/province [178] 0 0
Oaxaca
Country [179] 0 0
Mexico
State/province [179] 0 0
Sinaloa
Country [180] 0 0
Mexico
State/province [180] 0 0
Tamaulipas
Country [181] 0 0
Mexico
State/province [181] 0 0
Veracruz
Country [182] 0 0
Mexico
State/province [182] 0 0
Yucatán
Country [183] 0 0
Mexico
State/province [183] 0 0
Aguascalientes
Country [184] 0 0
Mexico
State/province [184] 0 0
Chihuahua
Country [185] 0 0
Mexico
State/province [185] 0 0
Durango
Country [186] 0 0
Mexico
State/province [186] 0 0
Mexico
Country [187] 0 0
Mexico
State/province [187] 0 0
Puebla
Country [188] 0 0
Mexico
State/province [188] 0 0
Querétaro
Country [189] 0 0
Mexico
State/province [189] 0 0
San Luis Potosí
Country [190] 0 0
Netherlands
State/province [190] 0 0
Drenthe
Country [191] 0 0
Netherlands
State/province [191] 0 0
Flevoland
Country [192] 0 0
Netherlands
State/province [192] 0 0
Fryslân
Country [193] 0 0
Netherlands
State/province [193] 0 0
Gelderland
Country [194] 0 0
Netherlands
State/province [194] 0 0
Limburg
Country [195] 0 0
Netherlands
State/province [195] 0 0
Noord-Brabant
Country [196] 0 0
Netherlands
State/province [196] 0 0
Noord-Holland
Country [197] 0 0
Netherlands
State/province [197] 0 0
Overijssel
Country [198] 0 0
Netherlands
State/province [198] 0 0
Utrecht
Country [199] 0 0
Netherlands
State/province [199] 0 0
Zuid-Holland
Country [200] 0 0
Netherlands
State/province [200] 0 0
Den Haag
Country [201] 0 0
Netherlands
State/province [201] 0 0
Zwijndrecht
Country [202] 0 0
Poland
State/province [202] 0 0
Dolnoslaskie
Country [203] 0 0
Poland
State/province [203] 0 0
Kujawsko-pomorskie
Country [204] 0 0
Poland
State/province [204] 0 0
Lubelskie
Country [205] 0 0
Poland
State/province [205] 0 0
Mazowieckie
Country [206] 0 0
Poland
State/province [206] 0 0
Malopolskie
Country [207] 0 0
Poland
State/province [207] 0 0
Opolskie
Country [208] 0 0
Poland
State/province [208] 0 0
Podkarpackie
Country [209] 0 0
Poland
State/province [209] 0 0
Podlaskie
Country [210] 0 0
Poland
State/province [210] 0 0
Pomorskie
Country [211] 0 0
Poland
State/province [211] 0 0
Warminsko-mazurskie
Country [212] 0 0
Poland
State/province [212] 0 0
Wielkopolskie
Country [213] 0 0
Poland
State/province [213] 0 0
Lódzkie
Country [214] 0 0
Poland
State/province [214] 0 0
Slaskie
Country [215] 0 0
Puerto Rico
State/province [215] 0 0
Bayamón
Country [216] 0 0
Puerto Rico
State/province [216] 0 0
San Juan
Country [217] 0 0
Romania
State/province [217] 0 0
Bra?ov
Country [218] 0 0
Romania
State/province [218] 0 0
Bucure?ti
Country [219] 0 0
Romania
State/province [219] 0 0
Dolj
Country [220] 0 0
Romania
State/province [220] 0 0
Maramure?
Country [221] 0 0
Romania
State/province [221] 0 0
Mure?
Country [222] 0 0
Romania
State/province [222] 0 0
Timi?
Country [223] 0 0
Romania
State/province [223] 0 0
Gala?i
Country [224] 0 0
Romania
State/province [224] 0 0
Ia?i
Country [225] 0 0
Romania
State/province [225] 0 0
Satu Mare
Country [226] 0 0
Romania
State/province [226] 0 0
Sibiu
Country [227] 0 0
Slovakia
State/province [227] 0 0
Banskobystrický Kraj
Country [228] 0 0
Slovakia
State/province [228] 0 0
Bratislavský Kraj
Country [229] 0 0
Slovakia
State/province [229] 0 0
Košický Kraj
Country [230] 0 0
Slovakia
State/province [230] 0 0
Nitriansky Kraj
Country [231] 0 0
Slovakia
State/province [231] 0 0
Trnavský Kraj
Country [232] 0 0
Slovakia
State/province [232] 0 0
Žilinský Kraj
Country [233] 0 0
Spain
State/province [233] 0 0
A Coruña [La Coruña]
Country [234] 0 0
Spain
State/province [234] 0 0
Almería
Country [235] 0 0
Spain
State/province [235] 0 0
Andalucía
Country [236] 0 0
Spain
State/province [236] 0 0
Asturias, Principado De
Country [237] 0 0
Spain
State/province [237] 0 0
Balears [Baleares]
Country [238] 0 0
Spain
State/province [238] 0 0
Barcelona [Barcelona]
Country [239] 0 0
Spain
State/province [239] 0 0
Cantabria
Country [240] 0 0
Spain
State/province [240] 0 0
Madrid
Country [241] 0 0
Spain
State/province [241] 0 0
Sevilla
Country [242] 0 0
Spain
State/province [242] 0 0
Valenciana, Comunitat
Country [243] 0 0
Spain
State/province [243] 0 0
València
Country [244] 0 0
Turkey
State/province [244] 0 0
Bursa
Country [245] 0 0
Turkey
State/province [245] 0 0
Eskisehir
Country [246] 0 0
Turkey
State/province [246] 0 0
Istanbul
Country [247] 0 0
Turkey
State/province [247] 0 0
Konya
Country [248] 0 0
Turkey
State/province [248] 0 0
Adana
Country [249] 0 0
Turkey
State/province [249] 0 0
Afyonkarahisar
Country [250] 0 0
Turkey
State/province [250] 0 0
Ankara
Country [251] 0 0
Turkey
State/province [251] 0 0
Antalya
Country [252] 0 0
Turkey
State/province [252] 0 0
Corum
Country [253] 0 0
Turkey
State/province [253] 0 0
Edirne
Country [254] 0 0
Turkey
State/province [254] 0 0
Gaziantep
Country [255] 0 0
Turkey
State/province [255] 0 0
Izmir
Country [256] 0 0
Turkey
State/province [256] 0 0
Kayseri
Country [257] 0 0
Turkey
State/province [257] 0 0
Kocaeli
Country [258] 0 0
Turkey
State/province [258] 0 0
Mersin
Country [259] 0 0
Turkey
State/province [259] 0 0
Sivas
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Aberdeen City
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Cornwall
Country [262] 0 0
United Kingdom
State/province [262] 0 0
England
Country [263] 0 0
United Kingdom
State/province [263] 0 0
Kingston Upon Hull
Country [264] 0 0
United Kingdom
State/province [264] 0 0
Somerset
Country [265] 0 0
United Kingdom
State/province [265] 0 0
Suffolk
Country [266] 0 0
United Kingdom
State/province [266] 0 0
Swansea [Abertawe Gb-ata]
Country [267] 0 0
United Kingdom
State/province [267] 0 0
Wirral
Country [268] 0 0
United Kingdom
State/province [268] 0 0
Birmingham
Country [269] 0 0
United Kingdom
State/province [269] 0 0
Coventry

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06383390
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06383390