Exenatide in Extreme Pediatric Obesity

Status:	Archived
Conditions:	Obesity Weight Loss
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	October 2010
End Date:	October 2011

Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated
with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM).
Obesity tracks strongly into adulthood and interventions early in life may reduce risk for
developing CVD and T2DM. Few drug therapies for weight loss have been evaluated in
adolescents. Since exenatide is associated with weight loss and improves risk factors for
CVD and T2DM in adults, it may be useful in extremely obese youth. Our primary objective in
this study is to generate preliminary data on the ability of exenatide to reduce body mass
index (BMI) and improve risk factors for CVD and T2DM in 26 extremely obese adolescents (age
12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical
trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is
an innovative approach to a challenging and significant health care problem

26 (approximately 13 per site) extremely obese (BMI > or = 1.2 times the 95th percentile or
BMI > or = 35 kg/m2) adolescents (age 12-19 years old) will be enrolled in a six-month study
consisting of a three-month, randomized, double-blind (participants and investigators),
placebo-controlled pilot clinical trial phase followed by a three-month open-label extension
during which all participants will receive exenatide. For the initial three-month phase,
participants will be equally (by site) and randomly assigned to one of two groups: 1)
exenatide plus lifestyle modification, or 2) placebo plus lifestyle modification. Following
baseline testing, subjects will be randomly assigned to study group. Participants will
return at one-month for titration and assessment of safety (blood draw and adverse event
assessment) and injection/lifestyle modification compliance and at three-months for
reassessment of baseline variables and injection/lifestyle modification compliance and
allocation to study drug for the three-month open-label extension. Participants will return
at four-months for assessment of safety (blood draw and adverse event assessment) and
injection/lifestyle modification compliance and at six-months for reassessment of baseline
variables and injection/lifestyle modification compliance.

All subjects, regardless of group assignment, will participate in the clinical lifestyle
modification program offered through either the University of Minnesota or Children's
Hospitals and Clinics weight management programs. Participants and their families receive
regular (approximately bi-monthly) face-to-face and/or phone behavioral-, dietary-, and
physical activity-counseling from a multi-disciplinary team of health care professionals
including physicians, dieticians, registered nurses, psychologists, and exercise
physiologists.

Screening will include review of medical records for previous clinical and laboratory data.
The following measures will be collected at baseline, 3 months, and 6 months. Subject will
be asked to fast for a minimum of 12 hours.

We found this trial at

sites

University of Minnesota Medical Center

2450 Riverside Avenue
Minneapolis, Minnesota 55455

(612) 273-3000