Autism Spectrum Disorder, Obesity
Conditions
Keywords
Autism Spectrum Disorder, Obesity, Semaglutide
Brief summary
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.
Interventions
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.
BEHAVIORALLifestyle Management (LSM) Counseling
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a mixed-methods study wherein we will recruit a prospective cohort (N=42) of 12-18-year-olds with ASD and obesity \[semaglutide group\] to whom we will prescribe semaglutide and provide ASD-tailored LSM counseling as standard of care. BMI, SMM, adiposity measures, and metabolic outcomes in the semaglutide group will be compared to the same outcomes in a retrospectively selected historical control group of youths with ASD and obesity who received LSM \[control group\] alone. We will conduct focused interviews with enrolled parents to explore issues related to semaglutide use.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Change in Body Weight | 12 months | Change in body weight from baseline |
| Number of Participants with Change in BMI z-Score | 12 months | Change in BMI z-score from baseline |
| Number of Participants with Change in Percent Body Fat | 12 months | Change in percent body fat measured by BIA |
| Number of Participants with Change in Fat Mass | 12 months | Change in fat mass measured by BIA |
| Number of Participants with Change in Fat-Free Mass | 12 months | Change in fat-free mass measured by BIA |
| Number of Participants with Change in Hemoglobin A1c | 12 months | Change in hemoglobin A1c from baseline |
| Number of Participants with Change in Fasting Insulin | 12 months | Change in fasting insulin from baseline |
| Number of Participants with Change in Fasting Glucose | 12 months | Change in fasting glucose from basline |
| Number of Participants with Change in Alanine Aminotransferase (ALT) | 12 months | Change in ALT from baseline |
| Number of Participants with Change in Aspartate Aminotransferase (AST) | 12 months | Change in AST from baseline |
| Number of Participants with Change in Gamma-Glutamyl Transferase (GGT) | 12 months | Change in GGT from baseline |
| Number of Participants with Change in Total Cholesterol | 12 months | Change in total cholesterol from baseline |
| Number of Participants with Change in LDL Cholesterol | 12 months | Change in LDL cholesterol from baseline |
| Number of Participants with Change in HDL Cholesterol | 12 months | Number of Participants with Change in HDL cholesterol from baseline |
| Number of Participants with Change in Triglycerides | 12 months | Change in triglycerides from baseline |
Countries
United States
Contacts
CONTACTMary Banks
PRINCIPAL_INVESTIGATORMelinda Mahabee-Gittens, MD, PhD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed