Adolescent Obesity and Effects of Semaglutide: The STEP TEENS Study – Phase IIIa

Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity

Protocol Description

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.

Study Level: Phase IIIa

Eligibility Criteria

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

Requirements

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: 80 weeks

Status: Open to Enrollment

Source(s) of Support

Novo Nordisk

Primary Investigator

Silva Arslanian, MD

Contact Information

For more information about the study or enrollment, please contact:
Study Coordinator Angela Akar, BS, CCRP
412-692-5928