πŸ›οΈ Verified NIH Record β€’ Updated 2026-08-14

Semaglutide in Youth With Autism Spectrum Disorder (NCT07770152)

Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)

🟑 Not Yet Recruiting Phase4 πŸ’Š Investigational Drug / Biologic Sponsor: Children's Hospital Medical Center, Cincinnati

🩺 Plain-English Summary (8th-Grade Level)

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/mΒ²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.

Who can join: Review the eligibility criteria below.

Location: Cincinnati Children's Hospital Medical Center β€” Cincinnati, Ohio

Age range: 12 Years to 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Cincinnati Children's Hospital Medical Center β€” Cincinnati, Ohio

πŸ“ž Contact the Study Coordinator

Phone: (513) 803-3123

Email: mary.banks@cchmc.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—