Semaglutide in Youth With Autism Spectrum Disorder

What Was Tested

The trial (phase 4) is built around Semaglutide.

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.

It had two arms (groups): Semaglutide + Autism Spectrum Disorder (ASD)-Tailored Lifestyle Management (active comparator) and Historical Control: ASD-Tailored Lifestyle Management Alone (other).

Participants aged 12-18 years with autism spectrum disorder (ASD) and obesity will receive semaglutide in combination with ASD-tailored lifestyle management (LSM) counseling for 12 months.

Historical Control - Retrospectively selected historical controls with ASD and obesity who previously received ASD-tailored lifestyle management (LSM) counseling without semaglutide.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 42 planned participants were the target.

It was open to people of any sex aged from 12 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-09-01 with completion listed for 2028-09-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Percent Change in BMI (kg/m2) (time frame: 12 months). Number of Participants With Change in Skeletal Muscle Mass (SMM) (time frame: 12 months).

It also tracked 15 secondary outcomes, for example Number of Participants with Change in Body Weight, Number of Participants with Change in BMI z-Score, Number of Participants with Change in Percent Body Fat, Number of Participants with Change in Fat Mass, Number of Participants with Change in Fat-Free Mass and Number of Participants with Change in Hemoglobin A1c.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Semaglutide in 42 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.