Are you Struggling With Obesity, or Being Overweight?
The purpose of this study is to find out whether an experimental medication helps people living with obesity 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. 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 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 participants’ body weight is regularly measured. 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) ≥30 kg/m^2 at screening, OR BMI ≥27 kg/m^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
- Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)
- Dyslipidemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low density lipoprotein (LDL) ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high density lipoprotein (HDL) <40 mg/dL (<1.0 mmol/L) for men or HDL<50 mg/dL (<1.3 mmol/L) for women)
- Obstructive sleep apnea
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
You may not qualify to participate if you:
- Have had a body weight change (self-reported) of >5% within 3 months before screening
- Have been treated with any medication for the indication of obesity within 3 months before screening.
- Have a history of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before screening.
- Experience heart failure
- Have any known clinically significant gastric emptying abnormality
- 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.