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Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth
Sponsor: Children's Hospital Los Angeles
Summary
This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.
Key Details
Gender
All
Age Range
12 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-06-01
Completion Date
2033-11-01
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
Semaglutide 2.4 mg
The dosing regimen will follow standard titration protocols, starting with a dose of 0.25 mg weekly for the first month, with gradual increases in dosage each month to a target dose of 2.4 mg weekly by the fifth month. To minimize the potential for side effects impacting daily activities, youth in the semaglutide group will be instructed to administer the medication weekly on Fridays.
Locations (1)
Children's Hospital Los Angeles
Los Angeles, California, United States