Are you Struggling With Obesity and Type 2 Diabetes?
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether an experimental medication helps people living with obesity, who also have diabetes, to lose weight.
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. Participants inject the study drug 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 about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants’ health and take note of any unwanted effects. The study staff also regularly measure participants’ body weight. The results are compared between the groups to see whether the treatment works.
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/m^2 at screening.
- Have been diagnosed with Type 2 diabetes mellitus (T2DM) at least 180 days prior to screening.
- Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
You may not qualify to participate if you:
- Have experienced body weight change (self-reported) of >5% within 3 months before screening.
- Have been treated with any medication for the indication obesity within 3 months before screening.
- Have been treated with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor [DPP-4il).
- Have any known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
- Have a history of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x upper limit of normal (ULN)) as measured by the central laboratory at screening.
- Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
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.