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Semaglutide in Youth With Autism Spectrum Disorder

NCT07770152 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Melinda Mahabee-Gittens, MD, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-01
Completion
2029-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07770152 on ClinicalTrials.gov