Reducing the Morbidity and Mortality of Obesity Study

Are you Overweight or Obese and Looking to Lose Weight?

This clinical research study is looking at the safety and effectiveness of medication for overweight and obese adults.

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 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:

• Have a BMI >27.0kg/m2
• Are ≥ 40 years of age with established CVD (secondary prevention) > 90 days prior to Visit 1. Established CVD is defined as having one of:
  • Coronary artery disease
  • Cerebrovascular disease
  • Peripheral arterial disease
• Are 50 years of age or older with at least 2-3 of the following risk factors:
  • Current tobacco use
  • Dyslipidemia
  • Hypertension
  • Kidney disease
  • Prediabetes
  • High coronary artery calcium score

You may not qualify to participate if you:

• Have Type 1 or Type 2 Diabetes, a history of ketoacidosis, or hypersmolar state/coma
• Have any one of the following cardiovascular conditions within 90 days prior to screening:
  • acute coronary syndrome
  • stroke
  • coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization
  • acute decompensated heart failure
• Have a planned coronary, carotid or peripheral artery revascularization procedure
• Have uncontrolled hypertension at Visit 1
• Have had or plan to have a surgical endoscopic or device treatment for obesity (Liposuction or abdominoplasty are exceptions)
• Use products intended for weight loss including prescription drugs, over-the-counter drugs and herbal preparations within 3 months prior to screening
• Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction
• Have a history of chronic or acute pancreatitis
• Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements
• Are in the opinion of the investigator, actively suicidal or have any lifetime history of a suicide attempt
• Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years prior to Visit 1in the opinion of the investigator. Examples include schizophrenia, bipolar disorder, or other serious mood or anxiety disorder.
• Have a history of any other condition, such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder, that, in the opinion of the investigator, may prevent the participant from following and completing the protocol

 

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.