Childhood Obesity and Effects of Liraglutide – Phase III

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

Protocol Description

The purpose of this study is to test the investigational drug liraglutide when used by adolescents with obesity. Liraglutide, which has been approved under the name Saxenda® for use in adults, is a modified form of GLP-1, a hormone produced naturally by the intestines that increases the feeling of fullness/satiety and leads to eating less food. Researchers believe it may also help adolescents to lose weight.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants of both genders, ages 12 through 17, who have a body weight that is higher than normal for their ages.
Males and Females: Ages 12 through 17

Requirements

The study is divided into two parts. In the first 12 weeks, participants will attend up to 6 visits, where they will discuss healthy eating and physical activity. Adolescents who meet all study criteria will be enrolled in the second part of the study, an 82-week program in which the study medications or a placebo are taken for 56 weeks and counseling in healthy nutrition and physical activity continued for 26 more weeks. By randomization, participants will receive either liraglutide or the placebo, to be given by self-injection using a special pen. During this time, participants will have 22 visits to the study site for assessments, blood tests, other physical exams, and dose adjustments. Researchers will monitor for changes in body mass index along with other metabolic factors.
Visits: Up to 28
Duration: About 1 year, 10 months

Status: Enrollment Closed

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 Nancy Guerra, CRNP
412-692-8405