A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: cardiovascular, cerebrovascular, kidney
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥27 required; conditions: Obesity
- Interventions
- survodutide; Placebo
- Conditions
- Obesity
- Phase and size
- Phase 3 · 5531 participants
- Dates
- Start 2023-11-20
Primary completion 2026-06-01 - Sponsor
- Boehringer Ingelheim (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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)up to Week 114
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.