The PHASE3 clinical trial for Survodutide (BI 456906), investigating cardiovascular safety in individuals with overweight or obesity, reached its primary completion on 2026-06-16. The study, known as SYNCHRONIZE™ - CVOT (NCT06077864), enrolled 5,531 participants.

Background

Survodutide is an investigational drug being studied for its effect on cardiovascular safety in people with overweight or obesity. The trial focused on adults with a body mass index (BMI) of 27 kg/m2 or more, including those with cardiovascular or chronic kidney disease, or at least two weight-related health problems or cardiovascular disease risks.

Trial design

The SYNCHRONIZE™ - CVOT study, identified as NCT06077864, is a PHASE3 trial designed to assess the effect of Survodutide on cardiovascular safety. The study enrolled 5,531 adult participants aged 18 years or older, all with a body mass index (BMI) of 27 kg/m2 or more. Participants included those with existing cardiovascular or chronic kidney disease, or at least two health problems related to their weight or cardiovascular disease risks, and who had previously attempted weight loss through diet modification.

The trial compared Survodutide (BI 456906) against placebo. The primary objective was to determine if participants taking Survodutide experienced a different likelihood of developing serious cardiovascular problems.

What this means

The primary completion of the PHASE3 SYNCHRONIZE™ - CVOT trial for Survodutide signifies that the main data collection period for its primary endpoint – assessing cardiovascular safety in individuals with overweight or obesity – has concluded. This milestone indicates progression towards the analysis of the collected data, which will ultimately inform the potential role of Survodutide in managing cardiovascular risks in this patient population. The results from this large-scale study, involving over 5,500 participants, are anticipated to provide crucial insights into the drug's safety profile and its impact on cardiovascular outcomes.

Source

The primary completion status for the Survodutide trial (NCT06077864) was updated on ClinicalTrials.gov on 2026-06-16. Further details on the study, SYNCHRONIZE™ - CVOT, are available on clinicaltrials.gov.