Preliminary evidence from a clinical trial suggests that treatment with glucagon-like peptide-1 (GLP-1) receptor agonists was associated with reduced body mass index and body weight in adolescents with severe obesity, according to a report published Online First by JAMA Pediatrics, a JAMA Network publication.
GLP-1 receptor agonist therapy, approved for adults with type 2 diabetes mellitus, reduces body weight by enhancing satiety and suppressing appetite, even in patients without diabetes, according to the study background.
Aaron S. Kelly, Ph.D., of the University of Minnesota Medical School, Minneapolis, and colleagues conducted a three-month, placebo-controlled trial followed by a three-month open-label extension during which medication was offered to all patients. A total of 22 patients (12 to 19 years of age) completed the trial, in which the medication exenatide was administered subcutaneously (injected).
"The results of this clinical trial extend the findings of our previous pilot and feasibility study and offer additional evidence, within the context of a randomized, placebo-controlled trial, that treatment with a GLP-1 receptor agonist significantly reduces BMI and body weight in adolescents with severe obesity," the authors note.
Exenatide caused a greater reduction in BMI compared with placebo (-2.7 percent). Researchers also observed a further reduction in BMI during the open-label phase for those patients initially randomized to exenatide (cumulative BMI reduction of 4 percent). The medication also resulted in a reduction, on average, in systolic blood pressure of -6mm HG, although researchers note it did not reach the level of statistical significance.
"In conclusion, data from the current study provide evidence that GLP-1 receptor agonist treatment reduces BMI and elicits a potentially meaningful reduction in SBP in adolescents with severe obesity," the authors conclude.
Editorial: Clinical Trials for Adolescent Obesity
In a related editorial, Jeffrey B. Schwimmer, M.D., of the University of California, San Diego, writes: "The need for medication(s) to treat pediatric obesity stems from the frequency and severity of childhood obesity and its complications."
"How to select which children merit treatment with medication and are most likely to benefit from a given treatment is a pressing issue for both clinical care and the research studies on which that care will be based," Schwimmer continues.
"Moving beyond the results of the current study, it is noteworthy that two new drugs were recently approved by the FDA [U.S. Food and Drug Administration] for the treatment of obesity in adults. Data on the safety and efficacy of these medications are needed in the pediatric population," he concludes.
- Kelly AS, Rudser KD, Nathan BM, et al. 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. JAMA Pediatrics, 2013; DOI: 10.1001/jamapediatrics.2013.1045
- Jeffrey B. Schwimmer. Clinical Trials for Adolescent Obesity: Cooking Up an Alphabet Stew of What to Do. JAMA Pediatrics, 2013; DOI: 10.1001/jamapediatrics.2013.1661
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