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NCT Number: NCT07770152

Semaglutide in Youth With Autism Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder Body Weight Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45245, United States

Location contact

Mary Banks

CONTACT

[email protected]

513-803-3123

Melinda Mahabee-Gittens, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Number of Participants With Percent Change in BMI (kg/m2)

    Time frame: 12 months

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

  2. Number of Participants With Change in Skeletal Muscle Mass (SMM)

    Time frame: 12 months

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

Secondary outcomes

  1. Number of Participants with Change in Body Weight

    Time frame: 12 months

    Change in body weight from baseline

  2. Number of Participants with Change in BMI z-Score

    Time frame: 12 months

    Change in BMI z-score from baseline

  3. Number of Participants with Change in Percent Body Fat

    Time frame: 12 months

    Change in percent body fat measured by BIA

  4. Number of Participants with Change in Fat Mass

    Time frame: 12 months

    Change in fat mass measured by BIA

  5. Number of Participants with Change in Fat-Free Mass

    Time frame: 12 months

    Change in fat-free mass measured by BIA

  6. Number of Participants with Change in Hemoglobin A1c

    Time frame: 12 months

    Change in hemoglobin A1c from baseline

  7. Number of Participants with Change in Fasting Insulin

    Time frame: 12 months

    Change in fasting insulin from baseline

  8. Number of Participants with Change in Fasting Glucose

    Time frame: 12 months

    Change in fasting glucose from basline

  9. Number of Participants with Change in Alanine Aminotransferase (ALT)

    Time frame: 12 months

    Change in ALT from baseline

  10. Number of Participants with Change in Aspartate Aminotransferase (AST)

    Time frame: 12 months

    Change in AST from baseline

  11. Number of Participants with Change in Gamma-Glutamyl Transferase (GGT)

    Time frame: 12 months

    Change in GGT from baseline

  12. Number of Participants with Change in Total Cholesterol

    Time frame: 12 months

    Change in total cholesterol from baseline

  13. Number of Participants with Change in LDL Cholesterol

    Time frame: 12 months

    Change in LDL cholesterol from baseline

  14. Number of Participants with Change in HDL Cholesterol

    Time frame: 12 months

    Number of Participants with Change in HDL cholesterol from baseline

  15. Number of Participants with Change in Triglycerides

    Time frame: 12 months

    Change in triglycerides from baseline

Other outcomes

  1. Rate of Semaglutide Initiation

    Time frame: 12 months

    Percentage of participants initiating semaglutide after approval

  2. Rate of Medication Adherence

    Time frame: 12 months

    Proportion of prescribed semaglutide doses administered.

  3. Rate of Medication Persistence

    Time frame: 12 months

    Time to discontinuation and persistence on therapy.

  4. Number of Participants who Achieve Target Dose

    Time frame: 12 months

    Percentage reaching semaglutide dose ≥1.7 mg.

  5. Rate of Gastrointestinal Adverse Effects

    Time frame: 12 months

    Incidence and severity of GI symptoms

  6. Rate of Semaglutide Tolerability

    Time frame: 12 months

    Patient/parent-reported symptom severity and dose reductions due to adverse effects

  7. Rate of Recruitment Feasibility

    Time frame: Enrollment period

    Percentage of eligible families who consent to participation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Banks

CONTACT

[email protected]

513-803-3123

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)

Acronym: GLP1

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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