Status:
NOT_YET_RECRUITING
Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Pediatric Obesity
Metabolic and Bariatric Surgery
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2033
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06934655
Start Date
November 1 2025
End Date
November 1 2033
Last Update
April 18 2025
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027