Survodutide SYNCHRONIZE™-CVOT Phase 3 Trial Reaches Primary Completion

The Phase 3 SYNCHRONIZE™-CVOT study (NCT06077864) investigating Survodutide reached its primary completion on May 1, 2026. This trial, which enrolled 5530 participants, is designed to assess the cardiovascular safety of Survodutide in individuals with overweight or obesity.

Background

Survodutide (also known as BI 456906) is being investigated for its potential effects on cardiovascular safety in people with overweight or obesity. The SYNCHRONIZE™-CVOT study specifically targets adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. Participants can include those with existing cardiovascular or chronic kidney disease, or individuals with at least two health problems related to their weight or risks of cardiovascular disease. All participants must have previously attempted weight loss through dietary changes.

Trial design

The SYNCHRONIZE™-CVOT study (NCT06077864) is a Phase 3 trial with an enrollment of 5530 participants. The study is designed to test the effect of Survodutide (BI 456906) on cardiovascular safety in people with obesity or overweight. Interventions include survodutide and placebo. The study's primary purpose is to determine whether individuals with overweight or obesity who take survodutide are less or more likely to develop serious cardiovascular problems.

What this means

The primary completion of the SYNCHRONIZE™-CVOT study marks a significant milestone in the evaluation of Survodutide. This indicates that the final data collection for the primary outcome measures has concluded for all participants. The next steps will involve comprehensive data analysis to determine the cardiovascular safety profile of Survodutide in the studied population. Understanding this profile is crucial for assessing its potential role in managing overweight and obesity, particularly in patients with co-morbidities and cardiovascular risk factors.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The study record for NCT06077864, titled "A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)," was updated on 2026-05-01 on clinicaltrials.gov.