Clinical trial

Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth

Recruiting now · Phase 3 · 1 countries · Registry ID NCT06934655

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionPediatric Obesity, Metabolic and Bariatric Surgery, Semaglutide

Full registry 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 * 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.

Treatments and study arms

Semaglutide 2.4 mg

Drug

The dosing regimen will follow standard titration protocols, starting with a dose of 0.25 mg weekly for the first month, with gradual increases in dosage each month to a target dose of 2.4 mg weekly by the fifth month. To minimize the potential for side effects impacting daily activities, youth in the semaglutide group will be instructed to administer the medication weekly on Fridays.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Children's Hospital Los Angeles🇺🇸 Los Angeles, California, United States

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Alaina Alaina Vidmar, MDPrincipal Investigator