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Autism Spectrum DisorderPhase 4GLP1NCT07770152

Semaglutide in Youth With Autism Spectrum Disorder

A Phase 4 study testing Glucagon-like peptide-1 receptor agonist：Semaglutide and Lifestyle Management (LSM) Counseling in people with Autism Spectrum Disorder and Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Autism Spectrum Disorder, Obesity
What is being tested?
Glucagon-like peptide-1 receptor agonist：Semaglutide and Lifestyle Management (LSM) Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 1 Sep 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to 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
  • Can attend in-person, e-visits, or telehealth visits for 12 months
Show all 13Show fewer
  • English speaking
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mary Banks contact

513-803-3123

mary.banks@cchmc.org

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45245

    Mary Banks, 513-803-3123, mary.banks@cchmc.org

    Melinda Mahabee-Gittens, MD, PhD

Other trials in United States

About this study

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

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.

Being tested
Glucagon-like peptide-1 receptor agonist：Semaglutide, Lifestyle Management (LSM) Counseling
Keywords
Autism Spectrum Disorder, Obesity, Semaglutide
Medical subject headings
Autism Spectrum Disorder, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucagon-like peptide-1 receptor agonist：SemaglutideDrug

    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) CounselingBehavioural

    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.

Study groups in NCT07770152
Study groupRoleWhat they receive
Semaglutide + Autism Spectrum Disorder (ASD)-Tailored Lifestyle ManagementActive comparatorParticipants 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.
Receives: Drug: Glucagon-like peptide-1 receptor agonist：Semaglutide; Behavioral: Lifestyle Management (LSM) Counseling
Historical Control: ASD-Tailored Lifestyle Management AloneOtherHistorical Control - Retrospectively selected historical controls with ASD and obesity who previously received ASD-tailored lifestyle management (LSM) counseling without semaglutide.
Receives: Behavioral: Lifestyle Management (LSM) Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months

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

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

    Measured: 12 months

Secondary outcomes (15)

  1. Number of Participants with Change in Body Weight

    Change in body weight from baseline

    Measured: 12 months

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

    Change in BMI z-score from baseline

    Measured: 12 months

  3. Number of Participants with Change in Percent Body Fat

    Change in percent body fat measured by BIA

    Measured: 12 months

  4. Number of Participants with Change in Fat Mass

    Change in fat mass measured by BIA

    Measured: 12 months

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

    Change in fat-free mass measured by BIA

    Measured: 12 months

  6. Number of Participants with Change in Hemoglobin A1c

    Change in hemoglobin A1c from baseline

    Measured: 12 months

  7. Number of Participants with Change in Fasting Insulin

    Change in fasting insulin from baseline

    Measured: 12 months

  8. Number of Participants with Change in Fasting Glucose

    Change in fasting glucose from basline

    Measured: 12 months

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

    Change in ALT from baseline

    Measured: 12 months

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

    Change in AST from baseline

    Measured: 12 months

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

    Change in GGT from baseline

    Measured: 12 months

  12. Number of Participants with Change in Total Cholesterol

    Change in total cholesterol from baseline

    Measured: 12 months

  13. Number of Participants with Change in LDL Cholesterol

    Change in LDL cholesterol from baseline

    Measured: 12 months

  14. Number of Participants with Change in HDL Cholesterol

    Number of Participants with Change in HDL cholesterol from baseline

    Measured: 12 months

  15. Number of Participants with Change in Triglycerides

    Change in triglycerides from baseline

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770152
Sponsor's protocol ID
2026-0494
Acronym
GLP1
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glucagon-like peptide-1 receptor agonist：Semaglutide and Lifestyle Management (LSM) Counseling in people with Autism Spectrum Disorder and Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mary Banks (513-803-3123, mary.banks@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Percent Change in BMI (kg/m2) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07770152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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