Childhood Obesity and Effects of Liraglutide: The SCALE KIDS Study – Phase III

Effect and Safety of Liraglutide 3.0 mg on Weight Management in Children with Obesity Aged 6 to Below 12 years

Protocol Description

The purpose of this study is to test the investigational drug liraglutide when used by children with obesity. Liraglutide is a modified form of GLP-1, a hormone produced naturally by the intestines that increases the feeling of fullness. It has been approved for use in adults and it has been studied in adolescent and teen populations. Researchers believe liraglutide may also help younger obese children to lose weight.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants ages 6 through 11, who are obese and otherwise healthy.
Boys and Girls: Ages 6 through 11

Requirements

Following a 2-week screening period, enrollees will participate in visits over 12 weeks to learn about healthy eating and physical activity. Randomly divided into two groups, participants will then receive either the study drug or a placebo daily via injection with a special pen over the next 56 weeks and will be followed by the study team for an additional 26 weeks. Participants will visit 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: 18 visits and 10 phone calls
Duration: 94 weeks (1 year and 8 months)

Status: Closed 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:
Angela Akar, Study Coordinator
412-692-5928