Is Your Child Struggling With Obesity and Losing Weight?
The purpose of this study is to find out whether an experimental medication helps adolescents living with obesity to lose weight.
The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.
Would you like your child to take part?
As a volunteer in a research study, your child will 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.
Your child may qualify to participate in this study if they:
- Are between the ages of 12 and 17 years old, inclusive
- Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
- Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
- Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).
Your child may not qualify to participate if they:
- Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to
- gastric bypass
- sleeve gastrectomy
- restrictive bariatric surgery, such as Lap-Band gastric banding, or
- any other procedure intended to result in weight reduction.
- Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
- Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
- Have type 2 diabetes or have a HbA1c > 6.4% at screening.
- 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.
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.