Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

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