A Phase 4 interventional study of Glucagon-like peptide-1 receptor agonist：Semaglutide and Lifestyle Management (LSM) Counseling in Autism Spectrum Disorder and Obesity, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 4, Interventional, and Treatment
Among 21 studies in Autism Spectrum Disorder by Children's Hospital Medical Center, Cincinnati — 6 open to participants now, 6 under way, none of them phase 3. Autism Spectrum Disorder · Children's Hospital Medical Center, Cincinnati.
Among the 21 studies in Autism Spectrum Disorder by Children's Hospital Medical Center, Cincinnati, this one is the 13th largest by planned enrollment of the 19 interventional ones, is the only one that started in 2026, is the only one in phase 4, and was the 21st registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 42 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →6 of the 21 studies in Autism Spectrum Disorder by Children's Hospital Medical Center, Cincinnati are open now, in 1 country. Each count lists the studies.
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 12 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2026.
Median enrollment 52 across the 19 interventional studies, 124 across the 2 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
1 of the studies in Autism Spectrum Disorder by Children's Hospital Medical Center, Cincinnati that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06227780Children's Hospital Medical Center, CincinnatiAlpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders | 2027-05-24 |
Among the 21 studies in Autism Spectrum Disorder by Children's Hospital Medical Center, Cincinnati, from their registry updates:
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.
Inclusion Criteria (Semaglutide Group):
Exclusion Criteria (Semaglutide Group):
Inclusion Criteria (Historical Control Group):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Glucagon-like peptide-1 receptor agonist：Semaglutide · Behavioral: Lifestyle Management (LSM) Counseling
Historical Control - Retrospectively selected historical controls with ASD and obesity who previously received ASD-tailored lifestyle management (LSM) counseling without semaglutide.
Behavioral: Lifestyle Management (LSM) Counseling
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.
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.
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
Number of Participants With Percent Change in BMI (kg/m2)
Percent change in BMI (kg/m2) from baseline to Month 12
Time frame: 12 months
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.
Time frame: 12 months
Number of Participants with Change in Body Weight
Change in body weight from baseline
Time frame: 12 months
Number of Participants with Change in BMI z-Score
Change in BMI z-score from baseline
Time frame: 12 months
Number of Participants with Change in Percent Body Fat
Change in percent body fat measured by BIA
Time frame: 12 months
Number of Participants with Change in Fat Mass
Change in fat mass measured by BIA
Time frame: 12 months
Number of Participants with Change in Fat-Free Mass
Change in fat-free mass measured by BIA
Time frame: 12 months
Number of Participants with Change in Hemoglobin A1c
Change in hemoglobin A1c from baseline
Time frame: 12 months
Number of Participants with Change in Fasting Insulin
Change in fasting insulin from baseline
Time frame: 12 months
Number of Participants with Change in Fasting Glucose
Change in fasting glucose from basline
Time frame: 12 months
Number of Participants with Change in Alanine Aminotransferase (ALT)
Change in ALT from baseline
Time frame: 12 months
Number of Participants with Change in Aspartate Aminotransferase (AST)
Change in AST from baseline
Time frame: 12 months
Number of Participants with Change in Gamma-Glutamyl Transferase (GGT)
Change in GGT from baseline
Time frame: 12 months
Number of Participants with Change in Total Cholesterol
Change in total cholesterol from baseline
Time frame: 12 months
Number of Participants with Change in LDL Cholesterol
Change in LDL cholesterol from baseline
Time frame: 12 months
Number of Participants with Change in HDL Cholesterol
Number of Participants with Change in HDL cholesterol from baseline
Time frame: 12 months
Number of Participants with Change in Triglycerides
Change in triglycerides from baseline
Time frame: 12 months
Rate of Semaglutide Initiation
Percentage of participants initiating semaglutide after approval
Time frame: 12 months
Rate of Medication Adherence
Proportion of prescribed semaglutide doses administered.
Time frame: 12 months
Rate of Medication Persistence
Time to discontinuation and persistence on therapy.
Time frame: 12 months
Number of Participants who Achieve Target Dose
Percentage reaching semaglutide dose ≥1.7 mg.
Time frame: 12 months
Rate of Gastrointestinal Adverse Effects
Incidence and severity of GI symptoms
Time frame: 12 months
Rate of Semaglutide Tolerability
Patient/parent-reported symptom severity and dose reductions due to adverse effects
Time frame: 12 months
Rate of Recruitment Feasibility
Percentage of eligible families who consent to participation.
Time frame: Enrollment period
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Semaglutide
Children's Hospital Medical Center, Cincinnati →