Semaglutide Tested in Teens With Autism and Obesity
Tests semaglutide with lifestyle counseling in teens with autism and obesity.
Plain-language title generated from the registry record
Registry title: Semaglutide in Youth With Autism Spectrum Disorder
Key facts
- Where
- Cincinnati, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 18 years old?
Source: NCT07770152, who can take part
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Trial code
- NCT07770152
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)
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.
Inclusion: 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; 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.
Exclusion: 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 significant GI conditions (e.g., pancreatitis),; Have catatonia or a condition that may affect compliance and safety; Healthworks patient who has lost >5% body weight over the past 3 months; Have been on GLP-1 RAs in the past 12 months; Are pregnant or breastfeeding.