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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT06077864 (opens ClinicalTrials.gov in a new tab)Other id1404-0040Other id2022-502442-27-00Other idU1111-1289-0174
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
5,531 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Quadruple masking
Countries
30 countries

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia

Start
20 Nov 2023
Primary completion
1 Jun 2026
Completion
30 Jun 2026
First posted
11 Oct 2023
Last update posted
30 Sept 2026
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 3

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

    NCT06077864

    20 Nov 2023 to 30 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • survodutideCombination product
  • PlaceboCombination product

Arms3

  • Experimental

    survodutide 3.6 mg

  • Experimental

    survodutide 6.0 mg

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(20)

  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

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Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Clinical trial · 2024

Survodutide for the Treatment of Obesity: Rationale and Design of the SYNCHRONIZE Cardiovascular Outcomes Trial.

Kosiborod et al. 2024JACC. Heart failurecited by 29

PMID 39453356DOI 10.1016/j.jchf.2024.09.004PUB-39453356

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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