Semaglutide in Youth With Autism Spectrum Disorder

Short name GLP1

NCTNCT07770152Other id2026-0494

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 4
Enrollment: 42 participants (estimated)
Sponsor: Children's Hospital Medical Center, Cincinnati · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Sept 2026 (estimated)
Primary completion: 1 Sept 2028 (estimated)
Completion: 1 Sept 2029 (estimated)
First posted: 18 Aug 2026
Last update posted: 18 Aug 2026
Conditions: Autism Spectrum Disorder · Obesity

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20262027202820292030

Ph 4
GLP1
NCT07770152
est. 1 Sept 2026 to est. 1 Sept 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Glucagon-like peptide-1 receptor agonist：SemaglutideDrug
Lifestyle Management (LSM) CounselingBehavioral

Arms2

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.

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Participants With Percent Change in BMI (kg/m2)
Time frame · 12 months
Registry description
Percent change in BMI (kg/m2) from baseline to Month 12
Number of Participants With Change in Skeletal Muscle Mass (SMM)
Time frame · 12 months
Registry description
Change in skeletal muscle mass measured by bioimpedance anaysis (BIA) from baseline to month 12.

Secondary outcomes(15)

Number of Participants with Change in Body Weight
Time frame · 12 months
Registry description
Change in body weight from baseline
Number of Participants with Change in BMI z-Score
Time frame · 12 months
Registry description
Change in BMI z-score from baseline
Number of Participants with Change in Percent Body Fat
Time frame · 12 months
Registry description
Change in percent body fat measured by BIA
Number of Participants with Change in Fat Mass
Time frame · 12 months
Registry description
Change in fat mass measured by BIA
Number of Participants with Change in Fat-Free Mass
Time frame · 12 months
Registry description
Change in fat-free mass measured by BIA
Number of Participants with Change in Hemoglobin A1c
Time frame · 12 months
Registry description
Change in hemoglobin A1c from baseline
Number of Participants with Change in Fasting Insulin
Time frame · 12 months
Registry description
Change in fasting insulin from baseline
Number of Participants with Change in Fasting Glucose
Time frame · 12 months
Registry description
Change in fasting glucose from basline
Number of Participants with Change in Alanine Aminotransferase (ALT)
Time frame · 12 months
Registry description
Change in ALT from baseline
Number of Participants with Change in Aspartate Aminotransferase (AST)
Time frame · 12 months
Registry description
Change in AST from baseline
Number of Participants with Change in Gamma-Glutamyl Transferase (GGT)
Time frame · 12 months
Registry description
Change in GGT from baseline
Number of Participants with Change in Total Cholesterol
Time frame · 12 months
Registry description
Change in total cholesterol from baseline
Number of Participants with Change in LDL Cholesterol
Time frame · 12 months
Registry description
Change in LDL cholesterol from baseline
Number of Participants with Change in HDL Cholesterol
Time frame · 12 months
Registry description
Number of Participants with Change in HDL cholesterol from baseline
Number of Participants with Change in Triglycerides
Time frame · 12 months
Registry description
Change in triglycerides from baseline

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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