What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Glucagon-like peptide-1 receptor agonist:Semaglutide, or Lifestyle Management (LSM) Counseling. The registry lists allocation as randomized. This study is a 6-month, two-arm, RCT which will measure the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity.
They plan to enroll about 42 people at Cincinnati. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)
Interventions: Glucagon-like peptide-1 receptor agonist:Semaglutide, Lifestyle Management (LSM) Counseling
Primary outcome (registry wording): Number of Participants With Percent Change in BMI (kg/m2)