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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06066528




Registration number
NCT06066528
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 Also 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 and Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
2022-502531-18-00
Secondary ID [2] 0 0
1404-0041
Universal Trial Number (UTN)
Trial acronym
SYNCHRONIZE™-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
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 at Week 76
Secondary outcome [5] 0 0
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Timepoint [5] 0 0
Baseline and at Week 76
Secondary outcome [6] 0 0
Absolute change from baseline to Week 76 in waist circumference (cm)
Timepoint [6] 0 0
Baseline and at Week 76
Secondary outcome [7] 0 0
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Timepoint [7] 0 0
Baseline and at Week 76
Secondary outcome [8] 0 0
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)
Timepoint [8] 0 0
Baseline and at Week 76
Secondary outcome [9] 0 0
Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Timepoint [9] 0 0
Baseline and at Week 76
Secondary outcome [10] 0 0
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
Timepoint [10] 0 0
Baseline and at Week 76
Secondary outcome [11] 0 0
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Timepoint [11] 0 0
Baseline and at Week 76
Secondary outcome [12] 0 0
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
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) cholesterol (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) cholesterol (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) cholesterol (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

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/m^2 at screening.
3. Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) =6.5% [=48 mmol/mol]) at least 180 days prior to screening.
4. HbA1c =6.5% (=48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening.
5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
6. 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. Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor [DPP-4il).
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
5. 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.
6. 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
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/01/2026
Actual
Sample size
Target
Accrual to date
Final
755
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [3] 0 0
CORE Research Group - Milton
Recruitment hospital [4] 0 0
Griffith Health - Southport
Recruitment hospital [5] 0 0
Monash University - Box Hill
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [8] 0 0
Keogh Institute for Medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
4064 - Milton
Recruitment postcode(s) [4] 0 0
4125 - Southport
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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California
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Florida
Country [5] 0 0
United States of America
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Georgia
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United States of America
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Hawaii
Country [7] 0 0
United States of America
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Idaho
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United States of America
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Illinois
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Indiana
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Iowa
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Kentucky
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Missouri
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Washington
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Aalst
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Leuven
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Beijing
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Changzhou
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Harbin
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Siping
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Nachod
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Fulda
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Hamburg
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Münster
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Witten
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Dunedin
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Nelson
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Newtown Wellington NZ
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New Zealand
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Rosedale, Auckland
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New Zealand
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Tauranga
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Poland
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Gdansk
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Lublin
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Pulawy
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Siedlce
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Poland
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Tarnow
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Spain
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A Coruña
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Spain
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Castilleja de la Cuesta
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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San Cristóbal de La Laguna
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Sweden
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Borås
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Sweden
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Göteborg
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Sweden
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Malmö
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Sweden
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Stockhom
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Sweden
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Örebro
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United Kingdom
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Blackpool
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United Kingdom
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Bradford on Avon
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Hayle
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Rotherham
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United Kingdom
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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
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)?
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/NCT06066528