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A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06077864
Recruitment Status : Recruiting
First Posted : October 11, 2023
Last Update Posted : June 11, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.


Condition or disease Intervention/treatment Phase
Obesity Drug: survodutide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4935 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 17, 2023
Estimated Primary Completion Date : March 12, 2026
Estimated Study Completion Date : April 2, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: survodutide 3.6 mg Drug: survodutide
once weekly subcutaneous injection
Other Name: BI 456906

Experimental: survodutide 6.0 mg Drug: survodutide
once weekly subcutaneous injection
Other Name: BI 456906

Placebo Comparator: Placebo Drug: Placebo
once weekly subcutaneous injection




Primary Outcome Measures :
  1. 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) [ Time Frame: up to Week 114 ]
    Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction


Secondary Outcome Measures :
  1. 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) [ Time Frame: up to Week 114 ]
  2. Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  3. Absolute change in waist circumference (cm) from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  4. Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline [ Time Frame: At Baseline and at Week 72 ]
    KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.

  5. 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) [ Time Frame: up to Week 114 ]
  6. Percentage change in body weight from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  7. Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  8. Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  9. Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  10. Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM) [ Time Frame: Baseline and at Week 72 ]
  11. Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM [ Time Frame: Baseline and at Week 72 ]
  12. Time to onset of T2DM in trial participants without T2DM at baseline [ Time Frame: up to Week 114 ]
  13. 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)) [ Time Frame: up to Week 114 ]
  14. 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) [ Time Frame: up to Week 114 ]
  15. 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) [ Time Frame: up to Week 114 ]
  16. Time to first occurrence of adjudicated CV death or adjudicated HFE [ Time Frame: up to Week 114 ]
  17. Time to first occurrence of adjudicated CV death or adjudicated HHF [ Time Frame: up to Week 114 ]
  18. Time to first occurrence of adjudicated HFE [ Time Frame: up to Week 114 ]
  19. Time to adjudicated CV death [ Time Frame: up to Week 114 ]
  20. Time to all-cause mortality [ Time Frame: up to Week 114 ]
  21. Time to first occurrence of adjudicated non-fatal MI [ Time Frame: up to Week 114 ]
  22. Time to first occurrence of adjudicated non-fatal stroke [ Time Frame: up to Week 114 ]
  23. Time to first occurrence of adjudicated ischaemia related coronary revascularisation [ Time Frame: up to Week 114 ]
  24. Achievement of body weight reduction ≥5% from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  25. Achievement of body weight reduction ≥10% from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  26. Achievement of body weight reduction ≥15% from baseline to Week 72 [ Time Frame: Baseline and at Week 72 ]
  27. 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 [ Time Frame: At baseline and at 72 Weeks ]

    Win ratio will be assessed as below:

    The primary efficacy endpoint will be analyzed using the clinical benefit approach comparing every participant in the BI 456906 arm to every participant in the placebo arm to determine a winner.

    A winner in the pair-wise comparison has a delayed time to the occurrence of death; if that cannot be determined, a winner has fewer HFEs; if the number of HFEs is the same a winner has a delayed time to the occurrence of first HFE; if that rule does not determine a winner, a winner has a more favorable (less increase or more decrease) change in KCCQ-CSS between baseline and at 72 weeks, otherwise the pair will be recorded as tied. The estimated net benefit (win ratio is then calculated as the total number of wins in the BI 456906 group across all strata divided by the total number of losses) will be provided.

    KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06077864


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT06077864    
Other Study ID Numbers: 1404-0040
2022-502442-27-00 ( Registry Identifier: CTIS )
U1111-1289-0174 ( Registry Identifier: WHO registry )
First Posted: October 11, 2023    Key Record Dates
Last Update Posted: June 11, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight