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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06066515




Registration number
NCT06066515
Ethics application status
Date submitted
27/09/2023
Date registered
4/10/2023

Titles & IDs
Public title
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Scientific title
A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity Without Type 2 Diabetes
Secondary ID [1] 0 0
U1111-1288-9400
Secondary ID [2] 0 0
1404-0038
Universal Trial Number (UTN)
Trial acronym
SYNCHRONIZE™-1
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
Percentage change in body weight from baseline to Week 76
Timepoint [1] 0 0
Baseline and at Week 76
Primary outcome [2] 0 0
Achievement of body weight reduction =5% (yes/no) from baseline to Week 76
Timepoint [2] 0 0
Baseline and at Week 76
Secondary outcome [1] 0 0
Achievement of body weight reduction =10% (yes/no) from baseline to Week 76
Timepoint [1] 0 0
Baseline and at Week 76
Secondary outcome [2] 0 0
Achievement of body weight reduction =15% (yes/no) from baseline to Week 76
Timepoint [2] 0 0
Baseline and at Week 76
Secondary outcome [3] 0 0
Achievement of body weight reduction =20% (yes/no) from baseline to Week 76
Timepoint [3] 0 0
Baseline and at Week 76
Secondary outcome [4] 0 0
Absolute change from baseline to Week 76 in body weight (kg)
Timepoint [4] 0 0
Baseline and Week 76
Secondary outcome [5] 0 0
Absolute change from baseline to Week 76 in waist circumference (cm)
Timepoint [5] 0 0
Baseline and at Week 76
Secondary outcome [6] 0 0
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Timepoint [6] 0 0
Baseline and at Week 76
Secondary outcome [7] 0 0
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)
Timepoint [7] 0 0
Baseline and at Week 76
Secondary outcome [8] 0 0
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Timepoint [8] 0 0
Baseline and at Week 76
Secondary outcome [9] 0 0
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
Timepoint [9] 0 0
Baseline and at Week 76
Secondary outcome [10] 0 0
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Timepoint [10] 0 0
Baseline and at Week 76
Secondary outcome [11] 0 0
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Timepoint [11] 0 0
Baseline and at Week 76
Secondary outcome [12] 0 0
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Timepoint [12] 0 0
Baseline and at Week 76
Secondary outcome [13] 0 0
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Timepoint [13] 0 0
Baseline and at Week 76
Secondary outcome [14] 0 0
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Timepoint [14] 0 0
Baseline and at Week 76
Secondary outcome [15] 0 0
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Timepoint [15] 0 0
Baseline and at Week 76
Secondary outcome [16] 0 0
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)
Timepoint [16] 0 0
Baseline and at Week 76
Secondary outcome [17] 0 0
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)
Timepoint [17] 0 0
Baseline and at Week 76
Secondary outcome [18] 0 0
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)
Timepoint [18] 0 0
Baseline and at Week 76
Secondary outcome [19] 0 0
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Timepoint [19] 0 0
Baseline and at Week 76
Secondary outcome [20] 0 0
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Timepoint [20] 0 0
Baseline and at Week 76
Secondary outcome [21] 0 0
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Timepoint [21] 0 0
Baseline and at Week 76
Secondary outcome [22] 0 0
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
Timepoint [22] 0 0
Baseline and at Week 76
Secondary outcome [23] 0 0
Absolute change from baseline to Week 76 in total fat volume (%)
Timepoint [23] 0 0
Baseline and at Week 76
Secondary outcome [24] 0 0
Absolute change from baseline to Week 76 in total fat volume (L)
Timepoint [24] 0 0
Baseline and at Week 76
Secondary outcome [25] 0 0
Absolute change from baseline to Week 76 in lean body volume (%)
Timepoint [25] 0 0
Baseline and at Week 76
Secondary outcome [26] 0 0
Absolute change from baseline to Week 76 in lean body volume (L)
Timepoint [26] 0 0
Baseline and at Week 76
Secondary outcome [27] 0 0
Absolute change from baseline to Week 76 in visceral fat volume (%)
Timepoint [27] 0 0
Baseline and at Week 76
Secondary outcome [28] 0 0
Absolute change from baseline to Week 76 in visceral fat volume (L)
Timepoint [28] 0 0
Baseline and at Week 76
Secondary outcome [29] 0 0
Absolute change from baseline to Week 76 in subcutaneous fat volume (%)
Timepoint [29] 0 0
Baseline and at Week 76.
Secondary outcome [30] 0 0
Absolute change from baseline to Week 76 in subcutaneous fat volume (L)
Timepoint [30] 0 0
Baseline and at Week 76.
Secondary outcome [31] 0 0
Relative change from baseline to Week 76 in liver fat content (%)
Timepoint [31] 0 0
Baseline and at Week 76

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) =30 kg/m^2 at screening, OR BMI =27 kg/m^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:

* Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of =140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of =90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)
* Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low density lipoprotein (LDL) =160 mg/dL (=4.1 mmol/L), or triglycerides =150 mg/dL (=1.7 mmol/L), or high density lipoprotein (HDL) <40 mg/dL (<1.0 mmol/L) for men or HDL<50 mg/dL (<1.3 mmol/L) for women)
* Obstructive sleep apnoea
* Others.
3. History of at least one self-reported unsuccessful dietary effort to lose body weight.

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
1. Body weight change (self-reported) of >5% within 3 months before screening.
2. Treatment with any medication for the indication obesity within 3 months before screening.
3. Glycosylated haemoglobin A1c (HbA1c) =6.5% (=48 mmol/mol) as measured by the central laboratory at screening.
4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before screening.
5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
7. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening.
8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/01/2026
Actual
Sample size
Target
Accrual to date
Final
726
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [2] 0 0
CORE Research Group - Milton
Recruitment hospital [3] 0 0
Griffith Health - Southport
Recruitment hospital [4] 0 0
Monash University - Box Hill
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [7] 0 0
Keogh Institute for Medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2291 - Merewether
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
4125 - Southport
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
North Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Aalst
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Belgium
State/province [24] 0 0
Roeselare
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
China
State/province [28] 0 0
Beijing
Country [29] 0 0
China
State/province [29] 0 0
Changchun
Country [30] 0 0
China
State/province [30] 0 0
Changzhou
Country [31] 0 0
China
State/province [31] 0 0
Guangzhou
Country [32] 0 0
China
State/province [32] 0 0
Hangzhou
Country [33] 0 0
China
State/province [33] 0 0
Harbin
Country [34] 0 0
China
State/province [34] 0 0
Henan Province
Country [35] 0 0
China
State/province [35] 0 0
Huzhou
Country [36] 0 0
China
State/province [36] 0 0
Jinan
Country [37] 0 0
China
State/province [37] 0 0
Luoyang
Country [38] 0 0
China
State/province [38] 0 0
Pingxiang
Country [39] 0 0
China
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Shanghai
Country [40] 0 0
China
State/province [40] 0 0
Siping
Country [41] 0 0
China
State/province [41] 0 0
Suzhou
Country [42] 0 0
China
State/province [42] 0 0
Tianjin
Country [43] 0 0
China
State/province [43] 0 0
Xi'an
Country [44] 0 0
China
State/province [44] 0 0
Zhenjiang
Country [45] 0 0
Finland
State/province [45] 0 0
Helsinki
Country [46] 0 0
Finland
State/province [46] 0 0
Jyväskylä
Country [47] 0 0
Finland
State/province [47] 0 0
Kuopio
Country [48] 0 0
Finland
State/province [48] 0 0
Turku
Country [49] 0 0
Germany
State/province [49] 0 0
Essen
Country [50] 0 0
Germany
State/province [50] 0 0
Fulda
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Münster
Country [53] 0 0
Japan
State/province [53] 0 0
Fukuoka, Fukuoka
Country [54] 0 0
Japan
State/province [54] 0 0
Hyogo, Kobe
Country [55] 0 0
Japan
State/province [55] 0 0
Ibaraki, Ushiku
Country [56] 0 0
Japan
State/province [56] 0 0
Saitama, Soka
Country [57] 0 0
Japan
State/province [57] 0 0
Tokyo, Hachioji
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Bucheon
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Daegu
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Goyang
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Korea, Republic of
State/province [61] 0 0
Incheon
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seongnam
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Seoul
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Suwon
Country [65] 0 0
Netherlands
State/province [65] 0 0
Born
Country [66] 0 0
Netherlands
State/province [66] 0 0
Groningen
Country [67] 0 0
Netherlands
State/province [67] 0 0
Rotterdam
Country [68] 0 0
New Zealand
State/province [68] 0 0
Dunedin
Country [69] 0 0
New Zealand
State/province [69] 0 0
Nelson
Country [70] 0 0
New Zealand
State/province [70] 0 0
Newtown Wellington NZ
Country [71] 0 0
New Zealand
State/province [71] 0 0
Rosedale, Auckland
Country [72] 0 0
New Zealand
State/province [72] 0 0
Tauranga
Country [73] 0 0
Poland
State/province [73] 0 0
Gdansk
Country [74] 0 0
Poland
State/province [74] 0 0
Lublin
Country [75] 0 0
Poland
State/province [75] 0 0
Pulawy
Country [76] 0 0
Poland
State/province [76] 0 0
Siedlce
Country [77] 0 0
Poland
State/province [77] 0 0
Tarnow
Country [78] 0 0
Sweden
State/province [78] 0 0
Borås
Country [79] 0 0
Sweden
State/province [79] 0 0
Göteborg
Country [80] 0 0
Sweden
State/province [80] 0 0
Stockhom
Country [81] 0 0
Sweden
State/province [81] 0 0
Örebro
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Blackpool
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Bradford on Avon
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Burbage, Hinkley
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Nantwich
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Rotherham
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Trowbridge

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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)?
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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/NCT06066515