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NOT YET RECRUITING
NCT07770152
PHASE4

Semaglutide in Youth With Autism Spectrum Disorder

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

BEHAVIORAL

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