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The Effect of Glucagon-Like Peptide-1 Receptor Agonist Therapy on Body Mass Index in Adolescents With Severe Obesity:  A Randomized, Placebo-Controlled, Clinical Trial ONLINE FIRST

Aaron S. Kelly, PhD; Kyle D. Rudser, PhD; Brandon M. Nathan, MD; Claudia K. Fox, MD, MPH; Andrea M. Metzig, MA; Brandon J. Coombes, BS; Angela K. Fitch, MD; Eric M. Bomberg, MD; M. Jennifer Abuzzahab, MD
JAMA Pediatr. 2013;():1-6. doi:10.1001/jamapediatrics.2013.1045.
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Importance  Medical treatment options for pediatric obesity remain limited. Glucagon-like peptide-1 (GLP-1) receptor agonists induce weight loss by suppressing appetite and increasing satiety, but few studies have evaluated this therapy as a treatment for obesity.

Objective  To evaluate the effects of exenatide on body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and cardiometabolic risk factors in adolescents with severe obesity.

Design  Three-month, randomized, double-blind, placebo-controlled, multicenter clinical trial followed by a 3-month open-label extension.

Setting  An academic medical center and an outpatient pediatric endocrinology clinic.

Patients  A total of 26 adolescents (12-19 years of age) with severe obesity (BMI ≥ 1.2 times the 95th percentile or BMI ≥ 35).

Intervention  All patients received lifestyle modification counseling and were equally randomized to exenatide or placebo injection, twice per day.

Main Outcome Measures  The primary end point was the mean percent change in BMI measured at baseline and 3 months. Secondary end points included absolute change in BMI, body weight, body fat, blood pressure, hemoglobin A1c, fasting glucose, fasting insulin, and lipids at 3 months.

Results  Twenty-two patients completed the trial. Exenatide elicited a greater reduction in percent change in BMI compared with placebo (−2.70% [95% CI, −5.02% to −0.37%]; P = .03). Similar findings were observed for absolute change in BMI (−1.13 [95% CI, −2.03 to −0.24]; P = .02) and body weight (−3.26 kg [95% CI, −5.87 to −0.66 kg]; P = .02). Although not reaching the level of statistical significance, reduction in systolic blood pressure was observed with exenatide. During the open-label extension, BMI was further reduced in those initially randomized to exenatide (cumulative BMI reduction of 4%).

Conclusions and Relevance  These results provide preliminary evidence supporting the feasibility, safety, and efficacy of GLP-1 receptor agonist therapy for the treatment of severe obesity in adolescents.

Trial Registration  clinicaltrials.gov Identifier:NCT01237197

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Figure 1. Consolidated Standard of Reporting Trials flow diagram showing the progress of adolescents with severe obesity throughout the 3-month, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the effects of exenatide on body mass index and cardiometabolic risk factors. *Defined as patients evaluated at a screening visit.

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Figure 2. The percent change in body mass index (BMI) during the randomized, placebo-controlled phase and the open-label phase of the trial. The lighter lines denote individual trajectories (ie, individual patients); the darker lines denote group trajectories (mean percent change in BMI by group at 3 and 6 months, with the errors bars indicating 95% CIs).

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