Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT05514054




Registration number
NCT05514054
Ethics application status
Date submitted
23/08/2022
Date registered
24/08/2022
Date last updated
25/06/2024

Titles & IDs
Public title
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Scientific title
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
Secondary ID [1] 0 0
J2J-MC-JZLH
Secondary ID [2] 0 0
18459
Universal Trial Number (UTN)
Trial acronym
EMBER-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imlunestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane

Experimental: Imlunestrant - Imlunestrant administered orally.

Active comparator: Investigator's Choice of Endocrine Therapy - Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.


Treatment: Drugs: Imlunestrant
Administered orally.

Treatment: Drugs: Tamoxifen
Administered per local approved label.

Treatment: Drugs: Anastrozole
Administered per local approved label.

Treatment: Drugs: Letrozole
Administered per local approved label.

Treatment: Drugs: Exemestane
Administered per local approved label.

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

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (IDFS)
Timepoint [1] 0 0
Randomization to recurrence or death from any cause (up to 10 years)
Secondary outcome [1] 0 0
Distant Recurrence-Free Survival (DRFS)
Timepoint [1] 0 0
Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Randomization to Death from Any Cause (up to 10 Years)
Secondary outcome [3] 0 0
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Timepoint [3] 0 0
Year 1, Month 2 to Month 4
Secondary outcome [4] 0 0
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
Timepoint [4] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [5] 0 0
Change from Baseline in the EORTC QLQ-C30 Role Functioning
Timepoint [5] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [6] 0 0
Change from Baseline in the EORTC QLQ-C30 Global QOL
Timepoint [6] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [7] 0 0
Proportion of Time on Study Treatment with High Overall Adverse Event Burden
Timepoint [7] 0 0
Visit 1 Day 1 up to end of Year 5

Eligibility
Key inclusion criteria
* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
* Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
* Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
* Must have an increased risk of disease recurrence based on clinical-pathological risk features.
* Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
* Have adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
* Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
* Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
* Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago.
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
* Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
* Participants with a history of any other cancer.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

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
Open (masking not used)
Who is / are masked / blinded?



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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Lake Macquarie Private Hospital - Newcastle
Recruitment hospital [6] 0 0
Mater Hospital Sydney - Sydney
Recruitment hospital [7] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [8] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
The Townsville Hospital - Townsville
Recruitment hospital [11] 0 0
Hervey Bay Hospital - Urraween
Recruitment hospital [12] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [13] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [15] 0 0
Ballarat Health Services - Ballarat Central
Recruitment hospital [16] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [17] 0 0
Monash Health - Clayton
Recruitment hospital [18] 0 0
Barwon Health - Geelong
Recruitment hospital [19] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [20] 0 0
Northern Hospital - Melbourne
Recruitment hospital [21] 0 0
Maroondah Hospital - Melbourne
Recruitment hospital [22] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [23] 0 0
Breast Cancer Research Centre-WA - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2290 - Newcastle
Recruitment postcode(s) [6] 0 0
2060 - Sydney
Recruitment postcode(s) [7] 0 0
0810 - Tiwi
Recruitment postcode(s) [8] 0 0
4740 - Mackay
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
4814 - Townsville
Recruitment postcode(s) [11] 0 0
4655 - Urraween
Recruitment postcode(s) [12] 0 0
5011 - Woodville
Recruitment postcode(s) [13] 0 0
7000 - Hobart
Recruitment postcode(s) [14] 0 0
7250 - Launceston
Recruitment postcode(s) [15] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [16] 0 0
3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3168 - Clayton
Recruitment postcode(s) [18] 0 0
3220 - Geelong
Recruitment postcode(s) [19] 0 0
3065 - Melbourne
Recruitment postcode(s) [20] 0 0
3076 - Melbourne
Recruitment postcode(s) [21] 0 0
3135 - Melbourne
Recruitment postcode(s) [22] 0 0
3630 - Shepparton
Recruitment postcode(s) [23] 0 0
6009 - Nedlands
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
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
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
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
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
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
Minnesota
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
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Ciudad Autónoma De Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Autónoma De Buenos Aire
Country [37] 0 0
Argentina
State/province [37] 0 0
Córdoba
Country [38] 0 0
Argentina
State/province [38] 0 0
Río Negro
Country [39] 0 0
Argentina
State/province [39] 0 0
Santa Fe
Country [40] 0 0
Argentina
State/province [40] 0 0
Tucumán
Country [41] 0 0
Argentina
State/province [41] 0 0
La Rioja
Country [42] 0 0
Argentina
State/province [42] 0 0
Mendoza
Country [43] 0 0
Argentina
State/province [43] 0 0
San Juan
Country [44] 0 0
Austria
State/province [44] 0 0
Steiermark
Country [45] 0 0
Austria
State/province [45] 0 0
Tirol
Country [46] 0 0
Austria
State/province [46] 0 0
WienWien
Country [47] 0 0
Austria
State/province [47] 0 0
Wien
Country [48] 0 0
Austria
State/province [48] 0 0
Salzburg
Country [49] 0 0
Belgium
State/province [49] 0 0
Bruxelles-Capitale, Région De
Country [50] 0 0
Belgium
State/province [50] 0 0
Hainaut
Country [51] 0 0
Belgium
State/province [51] 0 0
Limburg
Country [52] 0 0
Belgium
State/province [52] 0 0
Oost-Vlaanderen
Country [53] 0 0
Belgium
State/province [53] 0 0
Vlaams-Brabant
Country [54] 0 0
Belgium
State/province [54] 0 0
West-Vlaanderen
Country [55] 0 0
Belgium
State/province [55] 0 0
Ieper
Country [56] 0 0
Belgium
State/province [56] 0 0
Liège
Country [57] 0 0
Belgium
State/province [57] 0 0
Namur
Country [58] 0 0
Belgium
State/province [58] 0 0
Ottignies
Country [59] 0 0
Belgium
State/province [59] 0 0
Verviers
Country [60] 0 0
Brazil
State/province [60] 0 0
Bahia
Country [61] 0 0
Brazil
State/province [61] 0 0
Ceará
Country [62] 0 0
Brazil
State/province [62] 0 0
Espírito Santo
Country [63] 0 0
Brazil
State/province [63] 0 0
Goiás
Country [64] 0 0
Brazil
State/province [64] 0 0
Minas Gera
Country [65] 0 0
Brazil
State/province [65] 0 0
Paraná
Country [66] 0 0
Brazil
State/province [66] 0 0
Pará
Country [67] 0 0
Brazil
State/province [67] 0 0
Pernambuco
Country [68] 0 0
Brazil
State/province [68] 0 0
Rio Grande Do Sul
Country [69] 0 0
Brazil
State/province [69] 0 0
Rondônia
Country [70] 0 0
Brazil
State/province [70] 0 0
São Paulo
Country [71] 0 0
Brazil
State/province [71] 0 0
Brasilia
Country [72] 0 0
Brazil
State/province [72] 0 0
Rio de Janeiro
Country [73] 0 0
Canada
State/province [73] 0 0
Alberta
Country [74] 0 0
Canada
State/province [74] 0 0
British Columbia
Country [75] 0 0
Canada
State/province [75] 0 0
Ontario
Country [76] 0 0
Canada
State/province [76] 0 0
Quebec
Country [77] 0 0
China
State/province [77] 0 0
Anhui
Country [78] 0 0
China
State/province [78] 0 0
Beijing
Country [79] 0 0
China
State/province [79] 0 0
Fujian
Country [80] 0 0
China
State/province [80] 0 0
Guangdong
Country [81] 0 0
China
State/province [81] 0 0
Hainan
Country [82] 0 0
China
State/province [82] 0 0
Hebei
Country [83] 0 0
China
State/province [83] 0 0
Henan
Country [84] 0 0
China
State/province [84] 0 0
Hubei
Country [85] 0 0
China
State/province [85] 0 0
Hunan
Country [86] 0 0
China
State/province [86] 0 0
Jiangsu
Country [87] 0 0
China
State/province [87] 0 0
Jiangxi
Country [88] 0 0
China
State/province [88] 0 0
Jilin
Country [89] 0 0
China
State/province [89] 0 0
Shaanxi
Country [90] 0 0
China
State/province [90] 0 0
Shandong
Country [91] 0 0
China
State/province [91] 0 0
Shanghai
Country [92] 0 0
China
State/province [92] 0 0
Shanxi
Country [93] 0 0
China
State/province [93] 0 0
Sichuan
Country [94] 0 0
China
State/province [94] 0 0
Tianjin
Country [95] 0 0
China
State/province [95] 0 0
Xinjiang
Country [96] 0 0
China
State/province [96] 0 0
Zhejiang
Country [97] 0 0
Czechia
State/province [97] 0 0
Beroun
Country [98] 0 0
Czechia
State/province [98] 0 0
Brno-mesto
Country [99] 0 0
Czechia
State/province [99] 0 0
Moravskoslezský Kraj
Country [100] 0 0
Czechia
State/province [100] 0 0
Pardubický Kraj
Country [101] 0 0
Czechia
State/province [101] 0 0
Praha 4
Country [102] 0 0
Czechia
State/province [102] 0 0
Praha 5
Country [103] 0 0
Czechia
State/province [103] 0 0
Praha 8
Country [104] 0 0
Czechia
State/province [104] 0 0
Hradec Kralove
Country [105] 0 0
Finland
State/province [105] 0 0
Pirkanmaa
Country [106] 0 0
Finland
State/province [106] 0 0
Pohjanmaa
Country [107] 0 0
Finland
State/province [107] 0 0
Pohjois-Pohjanmaa
Country [108] 0 0
Finland
State/province [108] 0 0
Uusimaa
Country [109] 0 0
Finland
State/province [109] 0 0
Jyväskylä
Country [110] 0 0
France
State/province [110] 0 0
Aquitaine
Country [111] 0 0
France
State/province [111] 0 0
Bretagne
Country [112] 0 0
France
State/province [112] 0 0
Centre
Country [113] 0 0
France
State/province [113] 0 0
Charente-Maritime
Country [114] 0 0
France
State/province [114] 0 0
Doubs
Country [115] 0 0
France
State/province [115] 0 0
Haute-Vienne
Country [116] 0 0
France
State/province [116] 0 0
Hauts-de-Seine
Country [117] 0 0
France
State/province [117] 0 0
Isère
Country [118] 0 0
France
State/province [118] 0 0
Landes
Country [119] 0 0
France
State/province [119] 0 0
Languedoc-Roussillon
Country [120] 0 0
France
State/province [120] 0 0
Loire-Atlantique
Country [121] 0 0
France
State/province [121] 0 0
Lorraine
Country [122] 0 0
France
State/province [122] 0 0
Marne
Country [123] 0 0
France
State/province [123] 0 0
Meurthe-et-Moselle
Country [124] 0 0
France
State/province [124] 0 0
Moselle
Country [125] 0 0
France
State/province [125] 0 0
Pays-de-la
Country [126] 0 0
France
State/province [126] 0 0
Pyrénées-Atlantiques
Country [127] 0 0
France
State/province [127] 0 0
Pyrénées-Orientales
Country [128] 0 0
France
State/province [128] 0 0
Rhône-Alpes
Country [129] 0 0
France
State/province [129] 0 0
Vaucluse
Country [130] 0 0
France
State/province [130] 0 0
Vendée
Country [131] 0 0
France
State/province [131] 0 0
Vienne
Country [132] 0 0
France
State/province [132] 0 0
Clermont-Ferrand
Country [133] 0 0
France
State/province [133] 0 0
Nice
Country [134] 0 0
France
State/province [134] 0 0
Paris
Country [135] 0 0
France
State/province [135] 0 0
Saint-Grégoire
Country [136] 0 0
France
State/province [136] 0 0
Valenciennes
Country [137] 0 0
France
State/province [137] 0 0
Île-de-France
Country [138] 0 0
Germany
State/province [138] 0 0
Baden-Württemberg
Country [139] 0 0
Germany
State/province [139] 0 0
Bayern
Country [140] 0 0
Germany
State/province [140] 0 0
Brandenburg
Country [141] 0 0
Germany
State/province [141] 0 0
Hessen
Country [142] 0 0
Germany
State/province [142] 0 0
Mecklenburg-Vorpommern
Country [143] 0 0
Germany
State/province [143] 0 0
Nordrhein-Westfalen
Country [144] 0 0
Germany
State/province [144] 0 0
Rheinland-Pfalz
Country [145] 0 0
Germany
State/province [145] 0 0
Saarland
Country [146] 0 0
Germany
State/province [146] 0 0
Sachsen-Anhalt
Country [147] 0 0
Germany
State/province [147] 0 0
Schleswig-Holstein
Country [148] 0 0
Germany
State/province [148] 0 0
Thüringen
Country [149] 0 0
Germany
State/province [149] 0 0
Berlin
Country [150] 0 0
Germany
State/province [150] 0 0
Göttingen
Country [151] 0 0
Germany
State/province [151] 0 0
Mayen
Country [152] 0 0
Greece
State/province [152] 0 0
Acha?a
Country [153] 0 0
Greece
State/province [153] 0 0
Attikí (Region)
Country [154] 0 0
Greece
State/province [154] 0 0
Attikí
Country [155] 0 0
Greece
State/province [155] 0 0
Ioánnina
Country [156] 0 0
Greece
State/province [156] 0 0
Irakleío
Country [157] 0 0
Greece
State/province [157] 0 0
Kentrikí Makedonía
Country [158] 0 0
Greece
State/province [158] 0 0
Thessaloníki
Country [159] 0 0
Greece
State/province [159] 0 0
Thessalía
Country [160] 0 0
Hong Kong
State/province [160] 0 0
Hksar
Country [161] 0 0
Hong Kong
State/province [161] 0 0
Hong Kong
Country [162] 0 0
Hungary
State/province [162] 0 0
Bács-Kiskun
Country [163] 0 0
Hungary
State/province [163] 0 0
Szabolcs-Szatmár-Bereg
Country [164] 0 0
Hungary
State/province [164] 0 0
Budapest
Country [165] 0 0
Hungary
State/province [165] 0 0
Debrecen
Country [166] 0 0
India
State/province [166] 0 0
Andhra Pradesh
Country [167] 0 0
India
State/province [167] 0 0
Delhi
Country [168] 0 0
India
State/province [168] 0 0
Gujarat
Country [169] 0 0
India
State/province [169] 0 0
Karnataka
Country [170] 0 0
India
State/province [170] 0 0
Kerala
Country [171] 0 0
India
State/province [171] 0 0
Maharashtra
Country [172] 0 0
India
State/province [172] 0 0
Maharashtr
Country [173] 0 0
India
State/province [173] 0 0
Odisha
Country [174] 0 0
India
State/province [174] 0 0
Tamil Nadu
Country [175] 0 0
India
State/province [175] 0 0
Telangana
Country [176] 0 0
India
State/province [176] 0 0
Uttar Prad
Country [177] 0 0
India
State/province [177] 0 0
Chandigarh
Country [178] 0 0
Ireland
State/province [178] 0 0
Connaught
Country [179] 0 0
Ireland
State/province [179] 0 0
Cork
Country [180] 0 0
Ireland
State/province [180] 0 0
Dublin
Country [181] 0 0
Ireland
State/province [181] 0 0
Sligo
Country [182] 0 0
Ireland
State/province [182] 0 0
Waterford
Country [183] 0 0
Israel
State/province [183] 0 0
HaDarom
Country [184] 0 0
Israel
State/province [184] 0 0
HaMerkaz
Country [185] 0 0
Israel
State/province [185] 0 0
Tell Abib
Country [186] 0 0
Israel
State/province [186] 0 0
Yerushalayim
Country [187] 0 0
Israel
State/province [187] 0 0
?eifa
Country [188] 0 0
Italy
State/province [188] 0 0
Campania
Country [189] 0 0
Italy
State/province [189] 0 0
Catania
Country [190] 0 0
Italy
State/province [190] 0 0
Emilia-Romagna
Country [191] 0 0
Italy
State/province [191] 0 0
Liguria
Country [192] 0 0
Italy
State/province [192] 0 0
Lombardia
Country [193] 0 0
Italy
State/province [193] 0 0
Milano
Country [194] 0 0
Italy
State/province [194] 0 0
Roma
Country [195] 0 0
Italy
State/province [195] 0 0
Taranto
Country [196] 0 0
Italy
State/province [196] 0 0
Torino
Country [197] 0 0
Italy
State/province [197] 0 0
Toscana
Country [198] 0 0
Italy
State/province [198] 0 0
Ancona
Country [199] 0 0
Italy
State/province [199] 0 0
Bergamo
Country [200] 0 0
Italy
State/province [200] 0 0
Brindisi
Country [201] 0 0
Italy
State/province [201] 0 0
Macerata
Country [202] 0 0
Italy
State/province [202] 0 0
Modena
Country [203] 0 0
Italy
State/province [203] 0 0
Padova
Country [204] 0 0
Italy
State/province [204] 0 0
Parma
Country [205] 0 0
Italy
State/province [205] 0 0
Terni
Country [206] 0 0
Japan
State/province [206] 0 0
Aichi
Country [207] 0 0
Japan
State/province [207] 0 0
Chiba
Country [208] 0 0
Japan
State/province [208] 0 0
Ehime
Country [209] 0 0
Japan
State/province [209] 0 0
Gunma
Country [210] 0 0
Japan
State/province [210] 0 0
Hiroshima
Country [211] 0 0
Japan
State/province [211] 0 0
Hokkaido
Country [212] 0 0
Japan
State/province [212] 0 0
Hyogo
Country [213] 0 0
Japan
State/province [213] 0 0
Ibaraki
Country [214] 0 0
Japan
State/province [214] 0 0
Ishikawa
Country [215] 0 0
Japan
State/province [215] 0 0
Iwate
Country [216] 0 0
Japan
State/province [216] 0 0
Kanagawa
Country [217] 0 0
Japan
State/province [217] 0 0
Miyagi
Country [218] 0 0
Japan
State/province [218] 0 0
Nagano
Country [219] 0 0
Japan
State/province [219] 0 0
Okinawa
Country [220] 0 0
Japan
State/province [220] 0 0
Osaka
Country [221] 0 0
Japan
State/province [221] 0 0
Shimane
Country [222] 0 0
Japan
State/province [222] 0 0
Tochigi
Country [223] 0 0
Japan
State/province [223] 0 0
Tokyo
Country [224] 0 0
Japan
State/province [224] 0 0
Fukuoka
Country [225] 0 0
Japan
State/province [225] 0 0
Fukushima
Country [226] 0 0
Japan
State/province [226] 0 0
Gifu
Country [227] 0 0
Japan
State/province [227] 0 0
Kagoshima
Country [228] 0 0
Japan
State/province [228] 0 0
Kumamoto
Country [229] 0 0
Japan
State/province [229] 0 0
Kyoto
Country [230] 0 0
Japan
State/province [230] 0 0
Miyazaki
Country [231] 0 0
Japan
State/province [231] 0 0
Okayama
Country [232] 0 0
Japan
State/province [232] 0 0
Saitama
Country [233] 0 0
Japan
State/province [233] 0 0
Shizuoka
Country [234] 0 0
Japan
State/province [234] 0 0
Tokushima
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Chungcheongbuk-do [Chungbuk]
Country [236] 0 0
Korea, Republic of
State/province [236] 0 0
Chungcheongnam-do [Chungnam]
Country [237] 0 0
Korea, Republic of
State/province [237] 0 0
Incheon-gwangyeoksi [Incheon]
Country [238] 0 0
Korea, Republic of
State/province [238] 0 0
Jeonranamdo
Country [239] 0 0
Korea, Republic of
State/province [239] 0 0
Kyonggi-do
Country [240] 0 0
Korea, Republic of
State/province [240] 0 0
Kyongsangbuk-do
Country [241] 0 0
Korea, Republic of
State/province [241] 0 0
Pusan-Kwangyokshi
Country [242] 0 0
Korea, Republic of
State/province [242] 0 0
Seoul-teukbyeolsi [Seoul]
Country [243] 0 0
Korea, Republic of
State/province [243] 0 0
Taegu-Kwangyokshi
Country [244] 0 0
Korea, Republic of
State/province [244] 0 0
Ulsan-Kwangyokshi
Country [245] 0 0
Mexico
State/province [245] 0 0
Baja California
Country [246] 0 0
Mexico
State/province [246] 0 0
Chiapas
Country [247] 0 0
Mexico
State/province [247] 0 0
Distrito Federal
Country [248] 0 0
Mexico
State/province [248] 0 0
Guanajuato
Country [249] 0 0
Mexico
State/province [249] 0 0
Jalisco
Country [250] 0 0
Mexico
State/province [250] 0 0
Nuevo León
Country [251] 0 0
Mexico
State/province [251] 0 0
San Luis Potosí
Country [252] 0 0
Mexico
State/province [252] 0 0
Tamaulipas
Country [253] 0 0
Mexico
State/province [253] 0 0
Chihuahua
Country [254] 0 0
Mexico
State/province [254] 0 0
Oaxaca
Country [255] 0 0
Mexico
State/province [255] 0 0
Puebla
Country [256] 0 0
Mexico
State/province [256] 0 0
Querétaro
Country [257] 0 0
Mexico
State/province [257] 0 0
Toluca
Country [258] 0 0
Netherlands
State/province [258] 0 0
Drenthe
Country [259] 0 0
Netherlands
State/province [259] 0 0
Limburg
Country [260] 0 0
Netherlands
State/province [260] 0 0
Noord-Brabant
Country [261] 0 0
Netherlands
State/province [261] 0 0
Noord-Holland
Country [262] 0 0
Netherlands
State/province [262] 0 0
Overijssel
Country [263] 0 0
Netherlands
State/province [263] 0 0
Zuid-Holland
Country [264] 0 0
Poland
State/province [264] 0 0
Kujawsko-pomorskie
Country [265] 0 0
Poland
State/province [265] 0 0
Mazowieckie
Country [266] 0 0
Poland
State/province [266] 0 0
Malopolskie
Country [267] 0 0
Poland
State/province [267] 0 0
Opolskie
Country [268] 0 0
Poland
State/province [268] 0 0
Pomorskie
Country [269] 0 0
Poland
State/province [269] 0 0
Zachodniopomorskie
Country [270] 0 0
Poland
State/province [270] 0 0
Lódzkie
Country [271] 0 0
Portugal
State/province [271] 0 0
Lisboa
Country [272] 0 0
Portugal
State/province [272] 0 0
Porto
Country [273] 0 0
Portugal
State/province [273] 0 0
Setúbal
Country [274] 0 0
Romania
State/province [274] 0 0
Bra?ov
Country [275] 0 0
Romania
State/province [275] 0 0
Bucure?ti
Country [276] 0 0
Romania
State/province [276] 0 0
Cluj
Country [277] 0 0
Romania
State/province [277] 0 0
Constan?a
Country [278] 0 0
Romania
State/province [278] 0 0
Dolj
Country [279] 0 0
Romania
State/province [279] 0 0
Ilfov
Country [280] 0 0
Romania
State/province [280] 0 0
Timi?
Country [281] 0 0
Singapore
State/province [281] 0 0
Central Singapore
Country [282] 0 0
Slovakia
State/province [282] 0 0
Bratislavský Kraj
Country [283] 0 0
Spain
State/province [283] 0 0
A Coruña [La Coruña]
Country [284] 0 0
Spain
State/province [284] 0 0
Andalucía
Country [285] 0 0
Spain
State/province [285] 0 0
Balears [Baleares]
Country [286] 0 0
Spain
State/province [286] 0 0
Barcelona [Barcelona]
Country [287] 0 0
Spain
State/province [287] 0 0
Catalunya [Cataluña]
Country [288] 0 0
Spain
State/province [288] 0 0
Extremadura
Country [289] 0 0
Spain
State/province [289] 0 0
Jaén
Country [290] 0 0
Spain
State/province [290] 0 0
La Rioja
Country [291] 0 0
Spain
State/province [291] 0 0
Lleida [Lérida]
Country [292] 0 0
Spain
State/province [292] 0 0
Lugo [Lugo]
Country [293] 0 0
Spain
State/province [293] 0 0
Madrid, Comunidad De
Country [294] 0 0
Spain
State/province [294] 0 0
Murcia, Región De
Country [295] 0 0
Spain
State/province [295] 0 0
Málaga
Country [296] 0 0
Spain
State/province [296] 0 0
Navarra
Country [297] 0 0
Spain
State/province [297] 0 0
País Vasco
Country [298] 0 0
Spain
State/province [298] 0 0
Santa Cruz De Tenerife
Country [299] 0 0
Spain
State/province [299] 0 0
Tarragona
Country [300] 0 0
Spain
State/province [300] 0 0
Valenciana, Comunitat
Country [301] 0 0
Spain
State/province [301] 0 0
València
Country [302] 0 0
Spain
State/province [302] 0 0
Alicante
Country [303] 0 0
Spain
State/province [303] 0 0
Badajoz
Country [304] 0 0
Spain
State/province [304] 0 0
Burgos
Country [305] 0 0
Spain
State/province [305] 0 0
Granada
Country [306] 0 0
Spain
State/province [306] 0 0
Madrid
Country [307] 0 0
Spain
State/province [307] 0 0
Santa Cruz de Tenerife
Country [308] 0 0
Spain
State/province [308] 0 0
Segovia
Country [309] 0 0
Spain
State/province [309] 0 0
Sevilla
Country [310] 0 0
Spain
State/province [310] 0 0
Toledo
Country [311] 0 0
Spain
State/province [311] 0 0
Valladolid
Country [312] 0 0
Spain
State/province [312] 0 0
Zaragoza
Country [313] 0 0
Taiwan
State/province [313] 0 0
Tainan
Country [314] 0 0
Taiwan
State/province [314] 0 0
Taipei
Country [315] 0 0
Taiwan
State/province [315] 0 0
Changhua
Country [316] 0 0
Taiwan
State/province [316] 0 0
New Taipei City
Country [317] 0 0
Taiwan
State/province [317] 0 0
Taichung
Country [318] 0 0
Taiwan
State/province [318] 0 0
Taoyuan
Country [319] 0 0
Turkey
State/province [319] 0 0
Ankara
Country [320] 0 0
Turkey
State/province [320] 0 0
Istanbul
Country [321] 0 0
Turkey
State/province [321] 0 0
Izmir
Country [322] 0 0
Turkey
State/province [322] 0 0
Mugla
Country [323] 0 0
Turkey
State/province [323] 0 0
Adana
Country [324] 0 0
Turkey
State/province [324] 0 0
Antalya
Country [325] 0 0
Turkey
State/province [325] 0 0
Bursa
Country [326] 0 0
Turkey
State/province [326] 0 0
Diyarbakir
Country [327] 0 0
Turkey
State/province [327] 0 0
Edirne
Country [328] 0 0
Turkey
State/province [328] 0 0
Gaziantep
Country [329] 0 0
Turkey
State/province [329] 0 0
Kocaeli
Country [330] 0 0
Turkey
State/province [330] 0 0
Malatya
Country [331] 0 0
Turkey
State/province [331] 0 0
Mersin
Country [332] 0 0
Turkey
State/province [332] 0 0
Sakarya
Country [333] 0 0
Turkey
State/province [333] 0 0
Samsun
Country [334] 0 0
United Kingdom
State/province [334] 0 0
Devon
Country [335] 0 0
United Kingdom
State/province [335] 0 0
Essex
Country [336] 0 0
United Kingdom
State/province [336] 0 0
Great Brit
Country [337] 0 0
United Kingdom
State/province [337] 0 0
Greater Manchester
Country [338] 0 0
United Kingdom
State/province [338] 0 0
Hertfordshire
Country [339] 0 0
United Kingdom
State/province [339] 0 0
London, City Of
Country [340] 0 0
United Kingdom
State/province [340] 0 0
Midlothian
Country [341] 0 0
United Kingdom
State/province [341] 0 0
Liverpool
Country [342] 0 0
United Kingdom
State/province [342] 0 0
Reading

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.