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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06077864




Registration number
NCT06077864
Ethics application status
Date submitted
27/09/2023
Date registered
11/10/2023
Date last updated
1/11/2024

Titles & IDs
Public title
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Scientific title
A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
Secondary ID [1] 0 0
2022-502442-27-00
Secondary ID [2] 0 0
1404-0040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - survodutide
Treatment: Drugs - Placebo

Experimental: survodutide 3.6 mg -

Experimental: survodutide 6.0 mg -

Placebo comparator: Placebo -


Treatment: Drugs: survodutide
once weekly subcutaneous injection

Treatment: Drugs: Placebo
once weekly 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 of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)
Timepoint [1] 0 0
up to Week 114
Secondary outcome [1] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority)
Timepoint [1] 0 0
up to Week 114
Secondary outcome [2] 0 0
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72
Timepoint [2] 0 0
Baseline and at Week 72
Secondary outcome [3] 0 0
Absolute change in waist circumference (cm) from baseline to Week 72
Timepoint [3] 0 0
Baseline and at Week 72
Secondary outcome [4] 0 0
Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline
Timepoint [4] 0 0
At Baseline and at Week 72
Secondary outcome [5] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority)
Timepoint [5] 0 0
up to Week 114
Secondary outcome [6] 0 0
Percentage change in body weight from baseline to Week 72
Timepoint [6] 0 0
Baseline and at Week 72
Secondary outcome [7] 0 0
Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72
Timepoint [7] 0 0
Baseline and at Week 72
Secondary outcome [8] 0 0
Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72
Timepoint [8] 0 0
Baseline and at Week 72
Secondary outcome [9] 0 0
Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72
Timepoint [9] 0 0
Baseline and at Week 72
Secondary outcome [10] 0 0
Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)
Timepoint [10] 0 0
Baseline and at Week 72
Secondary outcome [11] 0 0
Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM
Timepoint [11] 0 0
Baseline and at Week 72
Secondary outcome [12] 0 0
Time to onset of T2DM in trial participants without T2DM at baseline
Timepoint [12] 0 0
up to Week 114
Secondary outcome [13] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE))
Timepoint [13] 0 0
up to Week 114
Secondary outcome [14] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE)
Timepoint [14] 0 0
up to Week 114
Secondary outcome [15] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE)
Timepoint [15] 0 0
up to Week 114
Secondary outcome [16] 0 0
Time to first occurrence of adjudicated CV death or adjudicated HFE
Timepoint [16] 0 0
up to Week 114
Secondary outcome [17] 0 0
Time to first occurrence of adjudicated CV death or adjudicated HHF
Timepoint [17] 0 0
up to Week 114
Secondary outcome [18] 0 0
Time to first occurrence of adjudicated HFE
Timepoint [18] 0 0
up to Week 114
Secondary outcome [19] 0 0
Time to adjudicated CV death
Timepoint [19] 0 0
up to Week 114
Secondary outcome [20] 0 0
Time to all-cause mortality
Timepoint [20] 0 0
up to Week 114
Secondary outcome [21] 0 0
Time to first occurrence of adjudicated non-fatal MI
Timepoint [21] 0 0
up to Week 114
Secondary outcome [22] 0 0
Time to first occurrence of adjudicated non-fatal stroke
Timepoint [22] 0 0
up to Week 114
Secondary outcome [23] 0 0
Time to first occurrence of adjudicated ischaemia related coronary revascularisation
Timepoint [23] 0 0
up to Week 114
Secondary outcome [24] 0 0
Achievement of body weight reduction =5% from baseline to Week 72
Timepoint [24] 0 0
Baseline and at Week 72
Secondary outcome [25] 0 0
Achievement of body weight reduction =10% from baseline to Week 72
Timepoint [25] 0 0
Baseline and at Week 72
Secondary outcome [26] 0 0
Achievement of body weight reduction =15% from baseline to Week 72
Timepoint [26] 0 0
Baseline and at Week 72
Secondary outcome [27] 0 0
A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline
Timepoint [27] 0 0
At baseline and at 72 Weeks

Eligibility
Key inclusion criteria
1. Male or female, age =18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years.
2. Body mass index (BMI) =27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI =30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

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. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
2. Type 1 diabetes.
3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

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 administering the treatment/s
The people assessing the outcomes
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
17/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/04/2026
Actual
Sample size
Target
4935
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Boden Initiative - Camperdown
Recruitment hospital [2] 0 0
Novatrials - Kotara
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
AusTrials - Taringa - Taringa
Recruitment hospital [5] 0 0
AusTrials - Wellers Hill
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Repatriation General Hospital - Daw Park
Recruitment hospital [8] 0 0
Advara Heart Care - Leabrook
Recruitment hospital [9] 0 0
Victorian Heart Hospital - Clayton
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Advara Heart Care - Joondalup
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
2289 - Kotara
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4068 - Taringa
Recruitment postcode(s) [5] 0 0
4121 - Wellers Hill
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5041 - Daw Park
Recruitment postcode(s) [8] 0 0
5068 - Leabrook
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6027 - Joondalup
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
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
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
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
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
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
Nevada
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New Mexico
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
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Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
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Oregon
Country [31] 0 0
United States of America
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Pennsylvania
Country [32] 0 0
United States of America
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Rhode Island
Country [33] 0 0
United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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Caba
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Bs As
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Mar del Plata
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Argentina
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Parque Velez Sarfield
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Villa Luro
Country [48] 0 0
Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Stockerau
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Austria
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Vienna
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Belgium
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Brugge
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Belgium
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Edegem
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Leuven
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Curitiba
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Fortaleza
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Brazil
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São José dos Campos
Country [66] 0 0
Brazil
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São Paulo
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Bulgaria
State/province [67] 0 0
Byala
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Dobrich
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Dupnitsa
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Plovdiv
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Sliven
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Sofia
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Yambol
Country [74] 0 0
Canada
State/province [74] 0 0
Alberta
Country [75] 0 0
Canada
State/province [75] 0 0
British Columbia
Country [76] 0 0
Canada
State/province [76] 0 0
Manitoba
Country [77] 0 0
Canada
State/province [77] 0 0
Nova Scotia
Country [78] 0 0
Canada
State/province [78] 0 0
Ontario
Country [79] 0 0
Canada
State/province [79] 0 0
Quebec
Country [80] 0 0
China
State/province [80] 0 0
Beijing
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Changchun
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Changzhou
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China
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Chongqing
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China
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Hangzhou
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China
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Harbin
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China
State/province [86] 0 0
Hengyang
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China
State/province [87] 0 0
Huai'an
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China
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Huzhou
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China
State/province [89] 0 0
Jinan
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China
State/province [90] 0 0
Lishui
Country [91] 0 0
China
State/province [91] 0 0
Luoyang
Country [92] 0 0
China
State/province [92] 0 0
Nanchang
Country [93] 0 0
China
State/province [93] 0 0
Nanjing
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China
State/province [94] 0 0
Nanyang
Country [95] 0 0
China
State/province [95] 0 0
Ningbo
Country [96] 0 0
China
State/province [96] 0 0
Qinhuangdao
Country [97] 0 0
China
State/province [97] 0 0
Shanghai
Country [98] 0 0
China
State/province [98] 0 0
Shijiazhuang
Country [99] 0 0
China
State/province [99] 0 0
Suzhou
Country [100] 0 0
China
State/province [100] 0 0
Xi'an
Country [101] 0 0
China
State/province [101] 0 0
Xianyang
Country [102] 0 0
China
State/province [102] 0 0
Zhenjiang
Country [103] 0 0
Czechia
State/province [103] 0 0
Brno
Country [104] 0 0
Czechia
State/province [104] 0 0
Havirov
Country [105] 0 0
Czechia
State/province [105] 0 0
Karlovy Vary
Country [106] 0 0
Czechia
State/province [106] 0 0
Nachod
Country [107] 0 0
Czechia
State/province [107] 0 0
Olomouc
Country [108] 0 0
Czechia
State/province [108] 0 0
Ostrava-Poruba
Country [109] 0 0
Czechia
State/province [109] 0 0
Plzen
Country [110] 0 0
Czechia
State/province [110] 0 0
Prague 2
Country [111] 0 0
Czechia
State/province [111] 0 0
Prague
Country [112] 0 0
Czechia
State/province [112] 0 0
Praha 8
Country [113] 0 0
Denmark
State/province [113] 0 0
Aarhus N
Country [114] 0 0
Denmark
State/province [114] 0 0
Copenhagen
Country [115] 0 0
Denmark
State/province [115] 0 0
Herlev
Country [116] 0 0
Denmark
State/province [116] 0 0
Herning
Country [117] 0 0
Denmark
State/province [117] 0 0
Hvidovre
Country [118] 0 0
Finland
State/province [118] 0 0
Helsinki
Country [119] 0 0
Finland
State/province [119] 0 0
Jyväskylä
Country [120] 0 0
Finland
State/province [120] 0 0
Pori
Country [121] 0 0
Finland
State/province [121] 0 0
Tampere
Country [122] 0 0
Finland
State/province [122] 0 0
Turku
Country [123] 0 0
Germany
State/province [123] 0 0
Aachen
Country [124] 0 0
Germany
State/province [124] 0 0
Berlin
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Germany
State/province [125] 0 0
Düsseldorf
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Germany
State/province [126] 0 0
Erlangen
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Germany
State/province [127] 0 0
Frankfurt
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Germany
State/province [128] 0 0
Freiburg
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Germany
State/province [129] 0 0
Hannover
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Germany
State/province [130] 0 0
Heidelberg
Country [131] 0 0
Germany
State/province [131] 0 0
Homburg
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Germany
State/province [132] 0 0
Kiel
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Germany
State/province [133] 0 0
Köln
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Germany
State/province [134] 0 0
Leipzig
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Germany
State/province [135] 0 0
Mainz
Country [136] 0 0
Germany
State/province [136] 0 0
Münster
Country [137] 0 0
Germany
State/province [137] 0 0
Pohlheim
Country [138] 0 0
Germany
State/province [138] 0 0
Tübingen
Country [139] 0 0
Greece
State/province [139] 0 0
Athens
Country [140] 0 0
Greece
State/province [140] 0 0
Haidari-Athens
Country [141] 0 0
Greece
State/province [141] 0 0
Heraklion, Crete
Country [142] 0 0
Greece
State/province [142] 0 0
Ioannina
Country [143] 0 0
Greece
State/province [143] 0 0
Larissa
Country [144] 0 0
Greece
State/province [144] 0 0
P. Faliro
Country [145] 0 0
Greece
State/province [145] 0 0
Psychiko
Country [146] 0 0
Greece
State/province [146] 0 0
Thessaloniki
Country [147] 0 0
Hong Kong
State/province [147] 0 0
Hong Kong
Country [148] 0 0
Hungary
State/province [148] 0 0
Baja
Country [149] 0 0
Hungary
State/province [149] 0 0
Budapest
Country [150] 0 0
Hungary
State/province [150] 0 0
Debrecen
Country [151] 0 0
Hungary
State/province [151] 0 0
Godollo
Country [152] 0 0
Hungary
State/province [152] 0 0
Gyula
Country [153] 0 0
Hungary
State/province [153] 0 0
Hatvan
Country [154] 0 0
Hungary
State/province [154] 0 0
Kalocsa
Country [155] 0 0
Hungary
State/province [155] 0 0
Kaposvar
Country [156] 0 0
Hungary
State/province [156] 0 0
Zalaegerszeg
Country [157] 0 0
India
State/province [157] 0 0
Aurangabad
Country [158] 0 0
India
State/province [158] 0 0
Bikaner
Country [159] 0 0
India
State/province [159] 0 0
Chennai
Country [160] 0 0
India
State/province [160] 0 0
Kanpur
Country [161] 0 0
India
State/province [161] 0 0
Maharashtra
Country [162] 0 0
India
State/province [162] 0 0
New Delhi
Country [163] 0 0
India
State/province [163] 0 0
Surat
Country [164] 0 0
Ireland
State/province [164] 0 0
Dublin 4
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Ireland
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Galway
Country [166] 0 0
Italy
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Bergamo
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Italy
State/province [167] 0 0
Latina
Country [168] 0 0
Italy
State/province [168] 0 0
Milano
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Italy
State/province [169] 0 0
Palermo
Country [170] 0 0
Italy
State/province [170] 0 0
Roma
Country [171] 0 0
Italy
State/province [171] 0 0
Siena
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Japan
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Aichi, Nagoya
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Japan
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Chiba, Matsudo
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Japan
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Fukuoka, Okawa
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Japan
State/province [175] 0 0
Fukushima, Koriyama
Country [176] 0 0
Japan
State/province [176] 0 0
Kanagawa, Kawasaki
Country [177] 0 0
Japan
State/province [177] 0 0
Kanagawa, Sagamihara
Country [178] 0 0
Japan
State/province [178] 0 0
Kanagawa, Yokohama
Country [179] 0 0
Japan
State/province [179] 0 0
Kochi, Kochi
Country [180] 0 0
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Wishaw

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet.

The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.

Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity.

Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
Trial website
https://clinicaltrials.gov/study/NCT06077864
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06077864