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

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

Medical Conditions

Obesity
Overweight


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2023 Mar 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : once weekly subcutaneous injection

Intervention Arm Group : survodutide 3.6 mg;survodutide 6.0 mg;

Intervention Type : DRUG
Intervention Description : once weekly subcutaneous injection

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Manchester Royal Infirmary
    Manchester
    M13 9WL
  • Queen Elizabeth University Hospital
    Glasgow
    G51 4TF
  • Leicester General Hospital
    Leicester
    LE5 4PW
  • Ninewells Hospital & Medical School
    Dundee
    DD1 9SY
  • Antrim Area Hospital
    Antrim
    BT41 2RL
  • Lincoln County Hospital
    Lincoln
    LN2 5QY
  • Altnagelvin Area Hospital
    Londonderry
    BT47 6SB
  • University Hospital Monklands
    Airdrie
    ML6 0JS
  • Synexus - Hexham
    Hexham
    NE46 1QJ
  • Synexus - Midlands
    Edgbaston
    B15 2SQ
  • Synexus - Glasgow
    Glasgow
    ML4 3NJ
  • Wellcome Trust Clinical Research Facility, Edinburgh
    Edinburgh
    EH4 2XU
  • William Harvey Research Limited
    London
    EC1M 6BQ
  • Swansea University Medical School
    Swansea
    SA2 8PP
  • University Hospital Wishaw
    Wishaw
    ML2 0QB
  • Royal Victoria Infirmary
    Newcastle upon Tyne
    NE2 4HH
  • Synexus - Cardiff
    Cardiff
    CF15 9SS
  • Synexus - Lancashire
    Chorley
    PR7 7NA
  • Synexus - Merseyside
    Liverpool
    L22 0LG
  • Synexus - Manchester
    Manchester
    M15 6SE


The study is sponsored by Boehringer Ingelheim




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Read full details for Trial ID: NCT06077864
Last updated 17 April 2025

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