A Study to Test the Effect of BI 456906 on Cardiovascular Safety in People With Overweight or Obesity

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 - SYNCHRONIZE - CVOT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230478

Enrollment

4935

Registered

2023-11-25

Start date

2023-12-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Drug: BI 456906 Drug: Placebo

Eligibility

Sex/Gender

All

Inclusion 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.

Exclusion criteria

Exclusion criteria: 1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1)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).

Design outcomes

Primary

Measure	Time frame
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)	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain

Contacts

Public ContactShizuko Kawahara

Boehringer Ingelheim

medchiken.jp@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026