Are you Struggling With Obesity, or Being Overweight?
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:
- At least 18 years of age at the time of signing informed consent
- For Study 1 –
- Have a BMI ≥ 30 kg/m2 OR
- BMI of 25 kg/m2 ≤ BMI < 30 kg/m2 with at least one of the following weight-related comorbidities:
- Have hypertension
- Have prediabetes
- Have dyslipidemia
- Have cardiovascular disease
- Have obstructive sleep apnea.
- For Study 2 –
- Have a BMI ≥ 25 kg/m2 and T2DM defined as below:
- Established diagnosis of T2DM
- Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
- Have a BMI ≥ 25 kg/m2 and T2DM defined as below:
- Have a stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
You may not qualify to participate if you:
- For Study 1 –
- Established diagnosis of T1DM or T2DM.
- For Study 2 –
- Have any of the following medical history, laboratory values, or complications related to diabetes:
- T1DM
- HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- Are currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Have any of the following medical history, laboratory values, or complications related to diabetes:
- Have a history of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
- Have a history/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 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.
