Join a Trial Testing a New Medication for Obesity and Weight-Related Conditions

Clinical Trials Identifier: NCT06077864

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

Diabetes Type: Adults with overweight or obesity who have weight-related health conditions with or without type 2 diabetes

Trial Sponsor: Boehringer Ingelheim

What is the aim of the study? 

This study will investigate the cardiovascular safety of survodutide, a new GLP-1/glucagon receptor agonist that is being developed for weight management. Specifically, this trial seeks to find out if participants who take survodutide are more or less likely to develop serious heart problems or stroke. 

Survodutide is a once-weekly injection. The drug is being developed for obesity as well as metabolic dysfunction-associated steatotic liver disease (MASLD), a common complication of obesity as well as diabetes. 

How does this trial work? 

The study will enroll nearly 5,000 adults with overweight or obesity and it will last about two years. Participants must have cardiovascular disease (CVD), chronic kidney disease (CKD), or risk factors for CVD. Some risk factors for CVD include prediabetes or type 2 diabetes, high blood pressure, and high cholesterol. 

Participants will be randomized to one of three groups: two groups will receive different doses of survodutide, and the other group will receive a placebo injection. Everyone will also receive counseling on physical activity and diet. 

Researchers will measure heart problems (such as heart attack, or heart failure events), stroke, as well as changes in blood pressure, waist circumference, body weight, and A1C. 

Why is the survodutide trial important? 

Medications like survodutide have been highly effective for weight loss and diabetes management. More recently, research has revealed that these medications may also reduce heart disease and kidney disease; there is also promising data for preventing liver disease. 

Survodutide has shown encouraging results in a previous trial, leading to weight loss of up to 19% in adults with overweight or obesity. Participants also saw improved cardiometabolic health, such as reduced blood pressure and waist circumference. Another study, published earlier this year, found survodutide led to significant improvements in MASH, a serious form of liver disease. 

In the past years, there have been several shortages of incretin medications like Ozempic, Wegovy, and Mounjaro. With the development of new medications like survodutide, it’s likely there will be more options in the future for people with diabetes, overweight and obesity. 

Are you interested in participating? 

You may be eligible if you:

• Have type 2 diabetes and are at least 18 years old
• Have a body mass index (BMI) of at least 27, with cardiovascular disease and/or at least two weight-related complications or risk factors for CVD; OR
• Have a BMI of at least 30 with CVD or chronic kidney disease, and/or at least two weight-related complications or risk factors for CVD
• Have previously tried to lose weight through dietary changes

People who have type 1 diabetes or who have tried a GLP-1 within the past 3 months are not eligible. See a full list of inclusion/exclusion criteria here. 

The trial is currently recruiting across many countries worldwide. To enroll or learn more about this study, contact [email protected] or call 1-800-243-0127. 

Learn more about new medications for weight management: 

• FDA Approves Wegovy to Reduce Heart Disease and Stroke Risk in People With Obesity
• Cardiovascular Benefits of Losing Weight and Keeping It Off
• Zepbound (Tirzepatide) FDA-Approved for Chronic Weight Management