Survodutide Phase 3 CVOT Study for Overweight/Obesity Completes Primary Endpoint

The Phase 3 SYNCHRONIZE™ - CVOT study evaluating survodutide (BI 456906) for cardiovascular safety in people with overweight or obesity completed its primary endpoint on 2026-05-08. This study enrolled 5,531 participants to assess the drug's impact on serious cardiovascular problems.

Background

Survodutide is being investigated for its potential role in managing overweight and obesity, particularly concerning cardiovascular outcomes. The SYNCHRONIZE™ - CVOT study specifically aims to determine if survodutide can reduce or increase the likelihood of serious cardiovascular problems in adults with overweight or obesity who also have existing cardiovascular or chronic kidney disease, or multiple weight-related health issues.

Trial design

The Phase 3 study, identified as NCT06077864, is titled "A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)". It enrolled 5,531 adult participants 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. Participants had also previously attempted weight loss through diet changes. The study's primary purpose is to find out whether participants taking survodutide are less or more likely to develop serious cardiovascular problems compared to those receiving placebo.

What this means

The primary completion of the SYNCHRONIZE™ - CVOT study signifies that the main data collection phase for its primary objective has concluded. This milestone indicates that the trial has gathered the necessary data to evaluate the cardiovascular safety profile of survodutide in the studied population. The next steps will involve data analysis and subsequent reporting of the findings, which will provide crucial insights into the drug's effects on cardiovascular outcomes in individuals with overweight or obesity. No specific results regarding efficacy or safety have been released at this stage.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06077864, titled "A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)", was posted on 2026-05-08 on clinicaltrials.gov.