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

NCT06077864 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing the safety of the drug survodutide (BI 456906) in people who are overweight or have obesity to see if it affects the risk of heart-related events.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 5,531 people

Who can join Ages 18+ · all sexes

Timeline Started 2023-11 · est. completion 2026-06

Where 540 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT06077864 ↗

Description as written by the study sponsor.

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. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.

Treatments tested

survodutide also known as BI 456906 Combination Product

once weekly subcutaneous injection, pre-filled syringe
Placebo Combination Product

once weekly subcutaneous injection, pre-filled syringe

Main thing measured	Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)
Sponsor	Boehringer Ingelheim
Conditions studied	Obesity
GLP-1 drugs	survodutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06077864 ↗