What this trial means for you
This study is opening soon at 1 US site. It's studying Semaglutide 2.4 mg for pediatric obesity, metabolic and bariatric surgery, semaglutide.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
California
- Children's Hospital Los Angeles — Los Angeles
View the official record on ClinicalTrials.gov →
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