Early reinitiation of semaglutide after sleeve gastrectomy in youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3a randomized, parallel-group trial enrolling about 150 participants. Participants are youths with severe obesity who had sleeve gastrectomy and have been on semaglutide 2.4 mg weekly prior to surgery. They are randomized to receive semaglutide 2.4 mg weekly starting two weeks after surgery or to standard postoperative care without pharmacotherapy for 24 months. Outcomes are collected at multiple time points up to 24 months, focusing on BMI change, safety and tolerability, cardiometabolic markers, eating behaviors, quality of life, adherence, and postoperative complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Alaina Vidmar, MD — Children's Hospital Los Angeles
• Study coordinator: Alaina P Vidmar, MD
• Email: avidmar@chla.usc.edu
• Phone: 530-383-1732

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.