A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
This research study is for adults aged 18 and over who are overweight or obese and have certain health issues like heart problems or chronic kidney disease, or other weight-related health concerns. The main goal is to find out if a new medicine called survodutide can help reduce serious heart-related problems. It also explores if this medicine can improve other health measures like blood pressure. Participants will take survodutide or a dummy medicine (placebo) once a week by injection under the skin. Everyone also gets advice on healthy eating and physical activity. The study lasts up to 2 years and 3 months, with regular check-ups to monitor health and any side effects.
At a glance
What is this study about?
This study is investigating a new medicine called survodutide, which is being developed to help people who are overweight or obese. Being overweight or obese can increase the risk of serious health problems, especially those affecting the heart and blood vessels.
The main purpose of this study is to see if survodutide can help reduce the chance of developing serious heart-related problems in adults who are overweight or obese and already have some health issues. It also aims to discover if the medicine can improve other important health signs like blood pressure. Participants will be closely monitored for their heart health and general well-being throughout the study.
This research is important because it could lead to new ways to help people manage their weight and reduce their risk of heart disease, which is a major concern for many people in the UK.
Key takeaways
- The study tests a new medicine, survodutide, for weight management and heart health.
- It's for adults who are overweight or obese with certain related health conditions.
- You'll take a weekly injection, either survodutide or a dummy medicine.
- Diet and exercise advice is provided to all participants.
- The study involves regular clinic visits and lasts over two years.
- The main goal is to see if it reduces serious heart problems.
Who may be eligible?
You might be able to join this study if you are an adult aged 18 or older and are overweight or obese. This means your Body Mass Index (BMI) should be 27 kg/m² or more (or 30 kg/m² or more if you have certain health conditions). You would also need to have tried to lose weight by changing your diet before.
To be considered, you should also have certain health conditions. This could include existing heart disease or chronic kidney disease, or at least two other health problems linked to your weight or risks for heart disease.
However, you cannot take part if you have certain types of diabetes (Type 1), have recently used similar weight-loss medicines (within the last three months), or have stomach issues that affect how food passes through your body.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Is your BMI 27 kg/m² or higher (or 30 kg/m² or higher for specific conditions)?
- Have you tried to lose weight through diet before?
- Do you have existing heart disease, chronic kidney disease, or at least two other weight-related risk factors for heart disease?
- Have you *not* recently used similar weight-loss injections (within 3 months)?
- Do you *not* have Type 1 diabetes or certain serious stomach problems?
What does participation involve?
If you join the study, you'll be in it for up to 2 years and 3 months. You will be put into one of three groups by chance: two groups will receive different doses of survodutide, and one group will receive a placebo (a dummy medicine with no active drug). You'll have a two out of three chance of receiving survodutide. Everyone in the study will inject their medicine (survodutide or placebo) under their skin once a week. You'll also receive advice on healthy eating and physical activity.
You'll need to visit the study clinic about 21 times during this period, or attend some remote visits via video calls. During these visits, the study doctors and nurses will check your heart health and general well-being. They will also keep track of any side effects you might experience.
Potential risks and benefits
Locations (540)
- Cardiology P.C.Verified postcodeBirmingham, United States
- AMR DaphneVerified postcodeDaphne, United States
- AMR MobileVerified postcodeMobile, United States
- Mobile Heart Specialists, PCVerified postcodeMobile, United States
- The Institute for Liver Health II DBA Arizona Clinical TrialsVerified postcodeChandler, United States
- Clinical Research Institute of Arizona, LLCVerified postcodeSun City West, United States
- AMR PhoenixVerified postcodeTempe, United States
- Arizona Liver Health-Tucson-67516Verified postcodeTucson, United States
- Yuma Clinical TrialsVerified postcodeYuma, United States
- Lynn Institute of the OzarksVerified postcodeLittle Rock, United States
- Velocity Clinical Research-Huntington ParkVerified postcodeHuntington Park, United States
- Velocity Clinical Research, San DiegoVerified postcodeLa Mesa, United States
Common questions
What is survodutide?
Survodutide is a new medicine being tested to help people who are overweight or obese with their weight and potentially improve their heart health.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine.
How often do I take the medicine?
You will inject the study medicine or placebo under your skin once a week.
How long does the study last?
The study will last for up to 2 years and 3 months.
Will I know if I get the real medicine?
No, you won't know if you are receiving survodutide or the placebo. This helps ensure the study results are accurate and unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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