Overview
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.
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
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.
