Recruiting
Phase 4

Semaglutide

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07770152

Conditions

Autism Spectrum Disorder

Obesity

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Glucagon-like peptide-1 receptor agonist：Semaglutide

Lifestyle Management (LSM) Counseling

Study Details

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.

Conditions

Autism Spectrum Disorder

Obesity

Study ID

NCT07770152

Start date

Oct 18, 2026

Status verified date

Nov, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Semaglutide + Autism Spectrum Disorder (ASD)-Tailored Lifestyle Management

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.

other: Historical Control: ASD-Tailored Lifestyle Management Alone

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

Interventions

Glucagon-like peptide-1 receptor agonist：Semaglutide

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

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Mary Banks

513-803-3123mary.banks@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45245

Contacts

Mary Banks

513-803-3123mary.banks@cchmc.org

Principal Investigator:

Melinda Mahabee-Gittens, MD, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • Autism Spectrum Disorder
  • Obesity
  • Semaglutide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.