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Sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Autism Spectrum Disorder, Obesity
Interventions: Glucagon-like peptide-1 receptor agonist：Semaglutide, Lifestyle Management (LSM) Counseling
Countries: United States
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.
Sex: ALL
Age: 12 Years to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria (Semaglutide Group): * 12-18 years of age * Epic-confirmed diagnosis of ASD * Obesity defined as BMI ≥95th percentile for age and sex * Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket * Have a parent who is willing to provide informed consent * Can attend in-person, e-visits, or telehealth visits for 12 months * English speaking Exclusion Criteria (Semaglutide Group): * Healthworks patient who has lost \>5% body weight over the past 3 months * Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months * Have Type 1 or Type 2 diabetes * Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2 * Have been on GLP-1 RAs in the past 12 months * Have significant GI conditions (e.g., pancreatitis), * Are pregnant or breastfeeding * Have catatonia or a condition that may affect compliance and safety Inclusion Criteria (Historical Control Group): * Healthworks patients treated between January 1, 2021-December 31, 2025 * 12-18 years of age * Confirmed diagnosis of ASD * Have obesity defined as BMI ≥95th percentile for age and sex * Have BMI and SMM outcomes assessed at M0, M6, or M12 * Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group
- Cincinnati, Ohio, United States