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This international study evaluates the investigational drug semaglutide on weight management in overweight and obese adolescents. Obesity in children and adolescents can lead to serious health issues, and weight loss has been associated with a decrease in the risk of developing multiple consequences. Lifestyle intervention, such as diet and exercise, is the first line of treatment for obesity. However, many find it hard to achieve and maintain, through lifestyle intervention alone, the significant weight loss required to reduce or prevent comorbidities. Through this study, researchers will evaluate pharmacotherapy with semaglutide in combination with nutrition and lifestyle education and intervention.
Subject to certain exclusion criteria, this study is enrolling participants of both genders, ages 12 through 17, who are obese or overweight.
Males and Females: Ages 12 through 17
Following a screening period, participants will attend counseling sessions on lifestyle change for 12 weeks. After that, for 68 weeks they will receive a once weekly injection of either semaglutide or a placebo, as determined by randomization. During that time, they will keep in touch with the research team through 14 phone calls and 17 site visits at UPMC Children’s Hospital of Pittsburgh. During the visits, participants will receive physical examinations and, at certain intervals, blood tests and electrocardiograms. They will also continue to receive counseling on healthy nutrition and physical exercise until the end of the study. Researchers will monitor for changes in body mass index along with other metabolic factors.
Visits: 17, plus 14 phone calls
Duration: 89 weeks
Study Description at National Institutes of Health
Endocrinology, Diabetes and Metabolism Research
Center for Pediatric Research in Obesity and Metabolism
Silva Arslanian, MD
For more information about the study or enrollment, please contact:
Study Coordinator Angela Akar, BS, CCRP
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One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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