Semaglutide in Youth With Autism Spectrum Disorder

Conditions

• Autism Spectrum Disorder
• Obesity

Eligibility Criteria

Sex

ALL

Age

12 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Glucagon-like peptide-1 receptor agonist：Semaglutide — DRUG
  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.
• Lifestyle Management (LSM) Counseling — BEHAVIORAL
  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.

Study Details

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.

Key Dates

First listed

Aug 18, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Sep 1, 2028

Completion

Sep 1, 2029

Study Design

Enrollment

42 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 Outcome Measure

Number of Participants With Percent Change in BMI (kg/m2) [ Time Frame: 12 months ]

Central Contacts

• Mary Banks
  513-803-3123
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

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