Clinical trial

Semaglutide in Youth With Autism Spectrum Disorder

Opening soon · Phase 4 · 1 countries · Registry ID NCT07770152

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionAutism Spectrum Disorder, Obesity

Full registry 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

Treatments and study arms

Glucagon-like peptide-1 receptor agonist：Semaglutide

Drug

Semaglutide may be increased every 1-3 months from 0.25 mg to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg, based on the provider's assessment, BIA results (i.e., if SMM remained stable, \<2 pounds/week lost), and side effects.

Lifestyle Management (LSM) Counseling

Behavioral

Participants received lifestyle management counseling consisting of education and guidance on nutrition, physical activity, caloric intake, behavioral modification, and weight-management strategies. Counseling was provided as part of standard clinical care without the addition of pharmacologic or investigational interventions.

Primary outcomes

Number of Participants With Percent Change in BMI (kg/m2)12 months

Percent change in BMI (kg/m2) from baseline to Month 12

Number of Participants With Change in Skeletal Muscle Mass (SMM)12 months

Change in skeletal muscle mass measured by bioimpedance anaysis (BIA) from baseline to month 12.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cincinnati Children's Hospital Medical Center🇺🇸 Cincinnati, Ohio, United States

Open map

Mary BanksContact

Email · Call 513-803-3123

Melinda Mahabee-Gittens, MD, PhDPrincipal Investigator