Register a trial

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/NCT06632457




Registration number
NCT06632457
Ethics application status
Date submitted
8/10/2024
Date registered
9/10/2024

Titles & IDs
Public title
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Scientific title
A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis
Secondary ID [1] 0 0
2024-513741-36-00
Secondary ID [2] 0 0
1404-0064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Dysfunction Associated Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

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

Experimental: Survodutide -

Placebo comparator: Placebo -


Treatment: Drugs: Survodutide
Subcutaneous injection

Treatment: Drugs: Placebo matching survodutide
Subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to =15 and progression to CSPH
Timepoint [1] 0 0
up to 4.5 years.
Secondary outcome [1] 0 0
Absolute change from baseline in enhanced liver fibrosis (ELF) score
Timepoint [1] 0 0
At baseline and at Week 76.
Secondary outcome [2] 0 0
Percentage change from baseline in body weight
Timepoint [2] 0 0
At baseline and at Week 76.
Secondary outcome [3] 0 0
Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) in participants with type 2 diabetes mellitus (T2DM) at baseline (%)
Timepoint [3] 0 0
At baseline and at Week 76.
Secondary outcome [4] 0 0
Absolute change from baseline in HbA1c in participants with T2DM at baseline (mmol/mol)
Timepoint [4] 0 0
At baseline and at Week 76.
Secondary outcome [5] 0 0
Absolute change from baseline in liver stiffness in FibroScan® vibration-controlled transient elastography (VCTE) (kPa)
Timepoint [5] 0 0
At baseline and at Week 76.
Secondary outcome [6] 0 0
Percentage change from baseline in liver stiffness in FibroScan® VCTE
Timepoint [6] 0 0
At baseline and at Week 76.
Secondary outcome [7] 0 0
Time to first occurrence of progression to CSPH
Timepoint [7] 0 0
up to 4.5 years.
Secondary outcome [8] 0 0
Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to =15
Timepoint [8] 0 0
up to 4.5 years.
Secondary outcome [9] 0 0
Occurrence of all-cause hospitalisation (first and recurrent)
Timepoint [9] 0 0
up to 4.5 years.
Secondary outcome [10] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)
Timepoint [10] 0 0
up to 4.5 years.
Secondary outcome [11] 0 0
Absolute changes from baseline in lipids (mg/dL)
Timepoint [11] 0 0
At baseline and at Week 76.
Secondary outcome [12] 0 0
Absolute change from baseline in aspartate aminotransferase (AST) (U/L)
Timepoint [12] 0 0
At baseline and at Week 76.
Secondary outcome [13] 0 0
Absolute change from baseline in alanine aminotransferase (ALT) (U/L)
Timepoint [13] 0 0
At baseline and at Week 76.
Secondary outcome [14] 0 0
Absolute change from baseline in liver stiffness assesses by magnetic resonance elastography (MRE)
Timepoint [14] 0 0
At baseline and at Week 76.

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male or female adults =18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years
2. Body mass index (BMI) =27 kg/m2(=25 kg/m2 for Asian trial participants)
3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427).
4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction =5% or FibroScan® with controlled attenuation parameter (CAP) =288 dB/m, obtained during the screening period or a historic MRI-PDFF or FibroScan® with CAP =12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (=12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
5. Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Current or history (<5 years) of significant alcohol consumption, defined as an average of >140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
2. Model of end-stage liver Disease (MELD) score >12 due to liver disease
3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:

* History of portal hypertension-related upper gastrointestinal (GI) bleeding
* Ascites
* Hepatic encephalopathy (HE) =Grade 1 according to the West Haven criteria
4. Any of the following lab test result at screening

* Albumin below <3.5 g/dL (<35.0 g/L)
* International normalised ratio (INR) >1.3 unless due to therapeutic anticoagulants
* Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is <20% of TBL.
* Alkaline phosphatase >1.5x ULN
* Platelet count <100,000/µL (<100 GI/L)
5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg))
7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN
9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
10. History of liver transplantation or listed for liver transplantation
11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
12. Further exclusion criteria apply

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
12/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/06/2029
Actual
Sample size
Target
1590
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Ciudad Autónoma de Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Florencio Varela
Country [31] 0 0
Argentina
State/province [31] 0 0
Pilar
Country [32] 0 0
Argentina
State/province [32] 0 0
Ramos Mejía
Country [33] 0 0
Austria
State/province [33] 0 0
Graz
Country [34] 0 0
Austria
State/province [34] 0 0
Linz
Country [35] 0 0
Austria
State/province [35] 0 0
Vienna
Country [36] 0 0
Austria
State/province [36] 0 0
Wels
Country [37] 0 0
Austria
State/province [37] 0 0
Wien
Country [38] 0 0
Belgium
State/province [38] 0 0
Anderlecht
Country [39] 0 0
Belgium
State/province [39] 0 0
Edegem
Country [40] 0 0
Belgium
State/province [40] 0 0
Genk
Country [41] 0 0
Belgium
State/province [41] 0 0
Liège
Country [42] 0 0
Brazil
State/province [42] 0 0
Belem
Country [43] 0 0
Brazil
State/province [43] 0 0
Cerqueira Cesar
Country [44] 0 0
Brazil
State/province [44] 0 0
Porto Alegre
Country [45] 0 0
Brazil
State/province [45] 0 0
Sao Jose Do Rio Preto
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Gorna Oryahovitsa
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Panagyurishte
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Sofia
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Stara Zagora
Country [50] 0 0
Canada
State/province [50] 0 0
Alberta
Country [51] 0 0
Canada
State/province [51] 0 0
British Columbia
Country [52] 0 0
Canada
State/province [52] 0 0
Quebec
Country [53] 0 0
Chile
State/province [53] 0 0
La Serena
Country [54] 0 0
Chile
State/province [54] 0 0
Vina del Mar
Country [55] 0 0
China
State/province [55] 0 0
Beijing
Country [56] 0 0
China
State/province [56] 0 0
Changchun
Country [57] 0 0
China
State/province [57] 0 0
Guangzhou
Country [58] 0 0
China
State/province [58] 0 0
Hangzhou
Country [59] 0 0
China
State/province [59] 0 0
Kunming
Country [60] 0 0
China
State/province [60] 0 0
Nanchang
Country [61] 0 0
China
State/province [61] 0 0
Nanjing
Country [62] 0 0
China
State/province [62] 0 0
Ningbo
Country [63] 0 0
China
State/province [63] 0 0
Shanghai
Country [64] 0 0
China
State/province [64] 0 0
Suzhou
Country [65] 0 0
China
State/province [65] 0 0
Tianjin
Country [66] 0 0
China
State/province [66] 0 0
Wuhan
Country [67] 0 0
China
State/province [67] 0 0
Xi'An
Country [68] 0 0
China
State/province [68] 0 0
Xi'an
Country [69] 0 0
China
State/province [69] 0 0
Zhejiang
Country [70] 0 0
Czechia
State/province [70] 0 0
Brno - Zidenice
Country [71] 0 0
Czechia
State/province [71] 0 0
Liberec
Country [72] 0 0
Czechia
State/province [72] 0 0
Plzen
Country [73] 0 0
Czechia
State/province [73] 0 0
Praha 2
Country [74] 0 0
Georgia
State/province [74] 0 0
Batumi
Country [75] 0 0
Georgia
State/province [75] 0 0
Tbilisi
Country [76] 0 0
Germany
State/province [76] 0 0
Berlin
Country [77] 0 0
Germany
State/province [77] 0 0
Bochum
Country [78] 0 0
Germany
State/province [78] 0 0
Dresden
Country [79] 0 0
Germany
State/province [79] 0 0
Frankfurt
Country [80] 0 0
Germany
State/province [80] 0 0
Freiburg
Country [81] 0 0
Germany
State/province [81] 0 0
Heidelberg
Country [82] 0 0
Germany
State/province [82] 0 0
Homburg
Country [83] 0 0
Germany
State/province [83] 0 0
Köln Lindenthal
Country [84] 0 0
Germany
State/province [84] 0 0
Lübeck
Country [85] 0 0
Germany
State/province [85] 0 0
Magdeburg
Country [86] 0 0
Germany
State/province [86] 0 0
Mainz
Country [87] 0 0
Germany
State/province [87] 0 0
Mannheim
Country [88] 0 0
Germany
State/province [88] 0 0
Münster
Country [89] 0 0
Germany
State/province [89] 0 0
Ulm
Country [90] 0 0
Germany
State/province [90] 0 0
Wiesbaden
Country [91] 0 0
Germany
State/province [91] 0 0
Würzburg
Country [92] 0 0
Hungary
State/province [92] 0 0
Budapest
Country [93] 0 0
India
State/province [93] 0 0
Ahemdabad
Country [94] 0 0
India
State/province [94] 0 0
Chandigarh
Country [95] 0 0
India
State/province [95] 0 0
Hyderabad
Country [96] 0 0
India
State/province [96] 0 0
Jaipur
Country [97] 0 0
India
State/province [97] 0 0
Kanpur
Country [98] 0 0
India
State/province [98] 0 0
Lucknow
Country [99] 0 0
India
State/province [99] 0 0
Nagpur
Country [100] 0 0
India
State/province [100] 0 0
New Delhi
Country [101] 0 0
India
State/province [101] 0 0
Rohtak
Country [102] 0 0
India
State/province [102] 0 0
Secunderabad
Country [103] 0 0
India
State/province [103] 0 0
Surat
Country [104] 0 0
Italy
State/province [104] 0 0
Milano
Country [105] 0 0
Italy
State/province [105] 0 0
Modena
Country [106] 0 0
Italy
State/province [106] 0 0
Napoli
Country [107] 0 0
Italy
State/province [107] 0 0
Padova
Country [108] 0 0
Italy
State/province [108] 0 0
Palermo
Country [109] 0 0
Italy
State/province [109] 0 0
Roma
Country [110] 0 0
Italy
State/province [110] 0 0
Rozzano (MI)
Country [111] 0 0
Italy
State/province [111] 0 0
Turin
Country [112] 0 0
Japan
State/province [112] 0 0
Bunkyo-ku
Country [113] 0 0
Japan
State/province [113] 0 0
Chiba
Country [114] 0 0
Japan
State/province [114] 0 0
Ehime, Toon
Country [115] 0 0
Japan
State/province [115] 0 0
Fukui, Fukui
Country [116] 0 0
Japan
State/province [116] 0 0
Fukuoka, Fukuoka
Country [117] 0 0
Japan
State/province [117] 0 0
Fukuoka, Kurume
Country [118] 0 0
Japan
State/province [118] 0 0
Gifu, Gifu
Country [119] 0 0
Japan
State/province [119] 0 0
Gifu, Ogaki
Country [120] 0 0
Japan
State/province [120] 0 0
Hanishina-gun
Country [121] 0 0
Japan
State/province [121] 0 0
Hiroshima, Hiroshima
Country [122] 0 0
Japan
State/province [122] 0 0
Hokkaido, Sapporo
Country [123] 0 0
Japan
State/province [123] 0 0
Ibaraki, Inashiki-gun
Country [124] 0 0
Japan
State/province [124] 0 0
Isehara
Country [125] 0 0
Japan
State/province [125] 0 0
Ishikawa, Kanazawa
Country [126] 0 0
Japan
State/province [126] 0 0
Izumo
Country [127] 0 0
Japan
State/province [127] 0 0
Kagawa, Takamatsu
Country [128] 0 0
Japan
State/province [128] 0 0
Kagoshima, Kagoshima
Country [129] 0 0
Japan
State/province [129] 0 0
Kanagawa, Kawasaki
Country [130] 0 0
Japan
State/province [130] 0 0
Kita-gun
Country [131] 0 0
Japan
State/province [131] 0 0
Kobe
Country [132] 0 0
Japan
State/province [132] 0 0
Kumamoto, Kumamoto
Country [133] 0 0
Japan
State/province [133] 0 0
Kure
Country [134] 0 0
Japan
State/province [134] 0 0
Kyoto, Kyoto
Country [135] 0 0
Japan
State/province [135] 0 0
Mie, Tsu
Country [136] 0 0
Japan
State/province [136] 0 0
Miyazaki, Miyazaki
Country [137] 0 0
Japan
State/province [137] 0 0
Nagano, Matsumoto
Country [138] 0 0
Japan
State/province [138] 0 0
Nagasaki, Omura
Country [139] 0 0
Japan
State/province [139] 0 0
Nara, Kashihara
Country [140] 0 0
Japan
State/province [140] 0 0
Nishinomiya
Country [141] 0 0
Japan
State/province [141] 0 0
Oita
Country [142] 0 0
Japan
State/province [142] 0 0
Okayama, Kurashiki
Country [143] 0 0
Japan
State/province [143] 0 0
Osaka, Suita
Country [144] 0 0
Japan
State/province [144] 0 0
Saga, Saga
Country [145] 0 0
Japan
State/province [145] 0 0
Sakai
Country [146] 0 0
Japan
State/province [146] 0 0
Sendai-shi
Country [147] 0 0
Japan
State/province [147] 0 0
Shinjuku-ku
Country [148] 0 0
Japan
State/province [148] 0 0
Shizuoka, Hamamatsu
Country [149] 0 0
Japan
State/province [149] 0 0
Shizuoka, Izunokuni
Country [150] 0 0
Japan
State/province [150] 0 0
Takasaki
Country [151] 0 0
Japan
State/province [151] 0 0
Tokyo, Bunkyo-ku
Country [152] 0 0
Japan
State/province [152] 0 0
Tokyo, Minato-ku
Country [153] 0 0
Japan
State/province [153] 0 0
Tokyo, Musashino
Country [154] 0 0
Japan
State/province [154] 0 0
Tokyo, Shinjuku-ku
Country [155] 0 0
Japan
State/province [155] 0 0
Wakayama
Country [156] 0 0
Japan
State/province [156] 0 0
Yokohama
Country [157] 0 0
Korea, Republic of
State/province [157] 0 0
Bucheon-Si
Country [158] 0 0
Korea, Republic of
State/province [158] 0 0
Busan
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Incheon
Country [160] 0 0
Korea, Republic of
State/province [160] 0 0
Seoul
Country [161] 0 0
Korea, Republic of
State/province [161] 0 0
Wonju-Si
Country [162] 0 0
Malaysia
State/province [162] 0 0
Ampang Jaya
Country [163] 0 0
Malaysia
State/province [163] 0 0
Kelantan
Country [164] 0 0
Malaysia
State/province [164] 0 0
Kuala Lumpur
Country [165] 0 0
Malaysia
State/province [165] 0 0
Putrajaya
Country [166] 0 0
Mexico
State/province [166] 0 0
Acapulco de Juarez
Country [167] 0 0
Mexico
State/province [167] 0 0
Benito Juarez, Mexico
Country [168] 0 0
Mexico
State/province [168] 0 0
Merida
Country [169] 0 0
Mexico
State/province [169] 0 0
Mexico City
Country [170] 0 0
Mexico
State/province [170] 0 0
Veracruz
Country [171] 0 0
New Zealand
State/province [171] 0 0
Auckland
Country [172] 0 0
New Zealand
State/province [172] 0 0
Canterbury
Country [173] 0 0
New Zealand
State/province [173] 0 0
Waikato
Country [174] 0 0
Poland
State/province [174] 0 0
Krakow
Country [175] 0 0
Poland
State/province [175] 0 0
Lodz
Country [176] 0 0
Poland
State/province [176] 0 0
Lublin
Country [177] 0 0
Poland
State/province [177] 0 0
Myslowice
Country [178] 0 0
Poland
State/province [178] 0 0
Warsaw
Country [179] 0 0
Poland
State/province [179] 0 0
Warszawa
Country [180] 0 0
Poland
State/province [180] 0 0
Wroclaw
Country [181] 0 0
Poland
State/province [181] 0 0
Lódz
Country [182] 0 0
Puerto Rico
State/province [182] 0 0
San Juan
Country [183] 0 0
Romania
State/province [183] 0 0
Bucuresti
Country [184] 0 0
Romania
State/province [184] 0 0
Cluj-Napoca
Country [185] 0 0
Romania
State/province [185] 0 0
Iasi
Country [186] 0 0
Saudi Arabia
State/province [186] 0 0
Ramah
Country [187] 0 0
Saudi Arabia
State/province [187] 0 0
Riyadh
Country [188] 0 0
Singapore
State/province [188] 0 0
Singapore
Country [189] 0 0
South Africa
State/province [189] 0 0
Johannesburg
Country [190] 0 0
South Africa
State/province [190] 0 0
Plumstead
Country [191] 0 0
Spain
State/province [191] 0 0
A Coruña
Country [192] 0 0
Spain
State/province [192] 0 0
Córdoba
Country [193] 0 0
Spain
State/province [193] 0 0
Madrid
Country [194] 0 0
Spain
State/province [194] 0 0
Majadahonda
Country [195] 0 0
Spain
State/province [195] 0 0
Pontevedra
Country [196] 0 0
Spain
State/province [196] 0 0
Santiago de Compostela
Country [197] 0 0
Spain
State/province [197] 0 0
Tarragona
Country [198] 0 0
Switzerland
State/province [198] 0 0
Geneve
Country [199] 0 0
Switzerland
State/province [199] 0 0
Lugano
Country [200] 0 0
Switzerland
State/province [200] 0 0
Zuerich
Country [201] 0 0
Taiwan
State/province [201] 0 0
Changhua City
Country [202] 0 0
Taiwan
State/province [202] 0 0
Kaohsuing City
Country [203] 0 0
Taiwan
State/province [203] 0 0
Taichung City
Country [204] 0 0
Taiwan
State/province [204] 0 0
Tainan City
Country [205] 0 0
Taiwan
State/province [205] 0 0
Taipei City
Country [206] 0 0
Taiwan
State/province [206] 0 0
Taoyuan City
Country [207] 0 0
Turkey
State/province [207] 0 0
Ankara
Country [208] 0 0
Turkey
State/province [208] 0 0
Bahcelievler
Country [209] 0 0
Turkey
State/province [209] 0 0
Bursa
Country [210] 0 0
Turkey
State/province [210] 0 0
Fatih
Country [211] 0 0
Turkey
State/province [211] 0 0
Istanbul
Country [212] 0 0
Turkey
State/province [212] 0 0
Izmir
Country [213] 0 0
Turkey
State/province [213] 0 0
Rize
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Aberdeen
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Acomb, York
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Birmingham
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Bristol
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Cambridge
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Dagenham
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Derby
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Enfield
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Exeter
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Frimley
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Glasgow
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Guildford
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Hull
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Liverpool
Country [228] 0 0
United Kingdom
State/province [228] 0 0
London
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Newcastle
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Northwood
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Nottingham
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Orpington
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Portsmouth
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Preston
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Rochdale
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Southampton
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Stockton-on-Tees
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Wallasey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Available to whom?
For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


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.


Results not provided in https://clinicaltrials.gov/study/NCT06632457