RightFit
Not 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

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