Status:
ACTIVE_NOT_RECRUITING
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2026
Estimated Enrollment :
5531 Patients enrolled
Trial Details
Trial ID
NCT06077864
Start Date
November 20 2023
End Date
June 22 2026
Last Update
January 9 2026
Active Locations (539)
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1
Cardiology P.C.
Birmingham, Alabama, United States, 35211
2
AMR Daphne
Daphne, Alabama, United States, 36526
3
AMR Mobile
Mobile, Alabama, United States, 36608
4
Mobile Heart Specialists, PC
Mobile, Alabama, United States, 36608