early re-initiation of semaglutide post sleeve gastrectomy in youth

Conditions: Pediatric Obesity; Metabolic and Bariatric Surgery; Semaglutide

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.

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:
inclusion criteria: * ages 12 to 18 years * tanner stage 3 or higher * severe obesity (defined as a bmi greater than 35 kg/m2 or bmi ≥140% of the 95th percentile) * currently undergoing primary surgical weight loss through the pediatric bariatric surgery pathway at children's hospital los angeles * be willing to have blood collected before and after surgical procedure at defined points * be willing to have clinical data entered into a prospective database; 8) presence of a consenting caregiver * be taking semaglutide 2.4 mg weekly as part of their routine medical care prior to surgery as part of their obesity treatment program, apart from any planned surgical procedure. exclusion criteria: * have a previous diagnosis of type 1 diabetes * taking any medications known to influence body composition or prevent weight loss or promote weight gain (e.g. prednisone) * have been diagnosed with syndromes or diseases that may influence the postoperative course (e.g., cushing syndrome, down syndrome, prader willi syndrome) * have significant comorbid medical conditions necessitating frequent hospitalization that may require interruption of medications and/or that would make early re-initiation of semaglutide unsafe due to the other medical comorbidities * refuse to comply with eligibility criteria.