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Semaglutide in Youth With Autism Spectrum Disorder
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
This study is a 6-month, two-arm, RCT which will evaluate the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (BMI, kg/m²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.
Official title: Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)
Key Details
Gender
All
Age Range
12 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-09-01
Completion Date
2029-09-01
Last Updated
2026-08-18
Healthy Volunteers
No
Conditions
Interventions
Glucagon-like peptide-1 receptor agonist:Semaglutide
Semaglutide may be increased every 1-3 months from 0.25 mg to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg, based on the provider's assessment, BIA results (i.e., if SMM remained stable, \<2 pounds/week lost), and side effects.
Lifestyle Management (LSM) Counseling
Participants received lifestyle management counseling consisting of education and guidance on nutrition, physical activity, caloric intake, behavioral modification, and weight-management strategies. Counseling was provided as part of standard clinical care without the addition of pharmacologic or investigational interventions.
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States