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Completed

NCT Number: NCT06077864

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

This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Investigaciones Metabolicas (CINME), Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
  • Type 1 diabetes.
  • 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.
  • Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

Further exclusion criteria apply.

Treatment and study plan

Survodutide

Combination Product

once weekly subcutaneous injection, pre-filled syringe

Other names: BI 456906

Placebo

Combination Product

once weekly subcutaneous injection, pre-filled syringe

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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