The PHASE3 SYNCHRONIZE™ - CVOT study, investigating Survodutide (BI 456906) for cardiovascular safety in people with overweight or obesity, completed its primary phase on 2026-06-01. This significant trial enrolled 5531 participants to assess the drug's effects.
Background
Survodutide is being investigated for its potential role in managing overweight or obesity, specifically focusing on its cardiovascular safety profile. The SYNCHRONIZE™ - CVOT study aims to determine if the drug impacts serious cardiovascular problems in this population.
Trial design
The PHASE3 SYNCHRONIZE™ - CVOT study (NCT06077864) is a randomized, placebo-controlled trial that enrolled 5531 adult participants. Eligible participants were at least 18 years old with a body mass index (BMI) of 27 kg/m2 or more. The study included individuals with existing cardiovascular or chronic kidney disease, or those with at least 2 health problems related to their weight or risks of cardiovascular disease. Participants had also previously attempted weight loss through diet changes. The interventions included survodutide and placebo, with the primary objective to evaluate the effect of survodutide on the likelihood of developing serious cardiovascular problems.
What this means
The primary completion of the PHASE3 SYNCHRONIZE™ - CVOT study marks a critical milestone for Survodutide. With 5531 participants, this large-scale trial is designed to provide robust data on the cardiovascular safety of survodutide in individuals with overweight or obesity and associated comorbidities. The completion signifies that the main data collection period for the primary endpoint has concluded, and the focus will now shift to data analysis and reporting of the findings.
Source
This information was sourced from ClinicalTrials.gov, documenting the primary completion of trial NCT06077864, which occurred on 2026-06-01. The study details are available on clinicaltrials.gov.