Early Semaglutide Re-Initiation After Sleeve Gastrectomy in Youth
This study is for young people aged 12 to 18 with severe obesity who are having sleeve gastrectomy (a type of weight-loss surgery). It's looking at whether restarting semaglutide (a medication) two weeks after surgery, compared to standard care without medication, helps maintain weight loss. You would have been taking semaglutide 2.4 mg weekly for at least 3 months before surgery to join. The study will follow 150 participants for 24 months to see how their Body Mass Index (BMI) changes. The current status of this study is unclear.
- Study design
- This is a Phase 3a randomized controlled trial, meaning participants are randomly assigned to one of two groups. It plans to enroll 150 youth.
- What's involved
- You would have blood collected before and after surgery at specific times. Assessments will occur at 1 month before surgery, on the day of surgery, and then at 1, 3, 6, 9, 12, 18, and 24 months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months after surgery to assess outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alaina Vidmar, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percent Body Mass IndexFrom enrollment to the end of the end of the study at 24 months
Percent Body Mass Index (%BMI) is calculated as the participant's BMI at each assessment time point expressed as a percentage of the 95th percentile BMI for age and sex, based on CDC growth charts. This metric is commonly used in pediatric populations to more accurately reflect degrees of obesity in youth, particularly at the upper end of the BMI distribution where standard BMI z-scores may lose sensitivity. Calculation Formula: %BMI = (Participant's BMI / 95th percentile BMI for age and sex) × 100 Type (continuous) Units (Percent) Justification: %BMI is used as a more precise and interpretable measure of adiposity in children and adolescents with severe obesity. It allows for consistent tracking of obesity severity and treatment response over time, even in populations whose BMI values significantly exceed the 95th percentile.