Are you Struggling With Obesity, or Being Overweight?
The purpose of this study is to find out whether people with obesity are less or more likely to develop serious cardiovascular problems after receiving an experimental medication. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease.
Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of the experimental treatment, and 1 group gets placebo. Placebo looks like the treatment in question, but does not contain any active ingredients. Participants inject the experimental treatment or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
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.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with obesity and weight loss, and whether it will be made widely available to all Canadians trying to manage obesity. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are age ≥18 years at the time of signing informed consent
- Have a body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.
You may not qualify to participate if you:
- Have previously been treated with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
- Have type 1 diabetes.
- Have any known, clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.