Semaglutide for teens with autism and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial enrolls adolescents aged 12-18 with autism spectrum disorder and obesity to receive semaglutide with lifestyle management or lifestyle management alone. The primary outcome is change in body mass index (BMI) from baseline to Month 6. Secondary outcomes include metabolic parameters, safety/tolerability, and adherence to the treatment regimen. The study uses a GLP-1 receptor agonist approach and allows in-person, telehealth, or e-visits over a 12-month participation window to accommodate families.

Why it matters

Who can join: the full rules

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

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Melinda Mahabee-Gittens, MD, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Mary Banks
• Email: mary.banks@cchmc.org
• Phone: 513-803-3123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.