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

What Was Tested

The trial (phase 3) is built around Survodutide.

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.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

The registry lists 5531 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: previous treatment with glucagon-like peptide-1 receptor (glp-1r) agonists within 3 months before screening; type 1 diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Survodutide and who got the comparison, which limits bias.

The Survodutide group and the comparison group ran side by side rather than switching.

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-11-20 with completion listed for 2026-06-01.

It ran at 540 sites in United States (153), China (34), Poland (34), Canada (25), Japan (24) and United Kingdom (21).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 27 secondary outcomes, for example Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72, Absolute change in waist circumference (cm) from baseline to Week 72, Percentage change in body weight from baseline to Week 72, Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72, Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72 and Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 5531 people.

With 5531 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.