Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth

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.

Detailed Description

Study Design: Phase 3a Randomized Controlled Trial of Early Re-initiation of Semaglutide After Sleeve Gastrectomy in Youth with Severe Obesity Study Type: Interventional (Clinical Trial) Study Phase: Phase 3a Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Participants: Estimated Enrollment - 150 participants Population: Youth aged \[12-18\] with severe obesity who have: Undergone sleeve gastrectomy Been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery Intervention Arms: Arm 1: Semaglutide Re-initiation Group Semaglutide 2.4 mg once weekly Re-initiated 2 weeks after sleeve gastrectomy Continued for 24 months postoperatively Arm 2: Standard Care Group No pharmacotherapy postoperatively Routine postoperative clinical follow-up for 24 months Assessment Time Points: Preoperative Assessments: 1 month before surgery Day of surgery Postoperative Assessments: 1 month 3 months 6 months 9 months 12 months 18 months 24 months Outcomes: Primary Outcome: Change in BMI or BMI z-score from baseline to 24 months Secondary Outcomes: Safety and tolerability of early semaglutide re-initiation Changes in weight and waist circumference Changes in cardiometabolic markers (e.g., HbA1c, lipids, blood pressure) Tertiary Outcomes: Changes in eating behaviors Quality of life assessments Adherence and persistence with medication Rate of postoperative complications

Eligibility Criteria

Interventions