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.