NCT07770152Not yet recruitingPhase 4
Semaglutide in Youth With Autism Spectrum Disorder
Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 12 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- NCT number
- NCT07770152
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 42
- From Sept 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.