Semaglutide in Youth With Autism Spectrum Disorder

NCT07770152 · Not yet recruiting

Last updated 2026-09-22

This clinical trial is testing whether the medication semaglutide can help reduce body mass index (BMI) in children and adolescents with autism spectrum disorder who are also affected by obesity.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 42 people Planned (estimated).

Who can join Ages 12–18 · all sexes

Timeline Started 2026-09 · est. completion 2029-09

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT07770152 ↗

Description as written by the study sponsor.

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.

Treatments tested

Glucagon-like peptide-1 receptor agonist：Semaglutide Drug

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 Behavioral

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.

Main thing measured	Number of Participants With Percent Change in BMI (kg/m2)
Sponsor	Children's Hospital Medical Center, Cincinnati
Conditions studied	Autism Spectrum Disorder, Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07770152 ↗