Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the safety and effectiveness (how well it works) of an investigational drug (called VI-o521) in treating obese (overweight) teens.
The US Food and Drug Administration (FDA) has approved this drug for the treatment of weight management in overweight and obese adults; however, it has not yet been approved for routine clinical use for adolescents. Therefore, it is considered investigational.
Who can participate?
Pre-teens and teens, 12 to 17 years old, who are obese (overweight), may be eligible for participation.
Those who have a history of any of the following, will NOT be able to participate in the study:
- Epilepsy, congenital heart disease, hypothyroidism, Cushing’s syndrome, type 1 diabetes, type 2 diabetes, glaucoma, kidney stones
- Use of insulin for medical treatment
- Bi-polar disorder, depression, suicidal behavior or use of anti-depressants
- Eating disorder (bulimia, binge eating)
- Bariatric surgery or weight loss surgery
- Use of any over-the-counter or prescription weight loss drug in the past 3 months
- Use of stimulants for treatment of ADHD within the past 3 months
- High blood pressure or use of medication to lower blood pressure
What will happen in the study?
If your child qualifies and you decide you want them to participate, you will come to Cincinnati Children’s for 6 study visits over the next 2 months.
The following procedures will happen during 1 or more of the study visits while your child is in this research study:
- Demographic, medication, medical and family history
- Height and body weight measurements
- Vital sign measurements – including temperature, breathing rate, blood pressure, heart rate
- Physical exam
- Fasting – your child will be asked to fast (nothing to eat or drink, except for water) for 8 to 10 hours before a study visit
- Patient health questionnaire – about overall self-esteem, depression, hunger levels
- Blood and urine samples for lab tests
- Electrocardiogram (ECG) – painless test that records the electrical activity of the heart
- Oral glucose tolerance test – your child will drink a very sweet drink and have blood samples taken over the course of a 2-hour period
- Dosing diary – your child will record his or her dosing time and bring this to every visit
Your child will first have a screening visit to see if he or she qualifies to participate in the study.
If your child does qualify, he or she will be "randomized" (by chance, like flipping a coin) into 1 of 3 study drug groups: mid-dose of VI-0521, top-dose of VI-0521 and placebo (looks like VI-0521 but contains no active drug).
Your child will take his or her study drug 1 time per day for the next 8 weeks. The dose should be taken in the morning at home, except on days when your child has clinic visits. Clinic visits will be every 2 weeks (a total of 4 visits while your child takes the study drug) at Cincinnati Children’s.
At the end of the 8 weeks, you and your child will have a final study visit. At this visit, you and your child will return to Cincinnati Children’s and bring the diary and any unused study drugs with you.
You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
Being in this study may or may not help your child right now. We hope that it will help your child lose weight but we don’t know if it will because there is still a lot to learn about this study treatment.
When we finish the study, we hope that we will know more about how this study drug affects obesity in adolescents. This may help other children with obesity and weight management later on. Information from this study may help researchers to develop new drugs to help others in the future.