drugset / Trial / NCT06934655

Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

NCT06934655

Phase 3 Not yet recruiting 150 enrolled Children's Hospital Los Angeles
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-06-01
Primary completion
2030-11-01
Completion
2033-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 2.4 mg

Indications

No indication recorded.