Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth
Recruiting
Phase 3
Interventional Study
Pediatric Obesity
Metabolic and Bariatric Surgery
Semaglutide
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Children's Hospital Los Angeles · Other
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About This Trial
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…
Trial Locations
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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
*…
Contacts
Kamran Samakar, MD
Kamran.Samakar@med.usc.edu
CONTACT