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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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
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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