Semaglutide in Youth With Autism Spectrum Disorder
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Glucagon-like peptide-1 receptor agonist：Semaglutide
- Lifestyle Management (LSM) Counseling
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov