A Phase 3 interventional study of Semaglutide 2.4 mg in Pediatric Obesity, Metabolic and Bariatric Surgery and Semaglutide, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Children's Hospital Los Angeles · Phase 3, Interventional, and Treatment
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.
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: Phase 3a
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Participants: Estimated Enrollment - 150 participants
Population:
Youth aged [12-18] with severe obesity who have:
Undergone sleeve gastrectomy
Been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery
Intervention Arms:
Arm 1: Semaglutide Re-initiation Group
Semaglutide 2.4 mg once weekly
Re-initiated 2 weeks after sleeve gastrectomy
Continued for 24 months postoperatively
Arm 2: Standard Care Group
No pharmacotherapy postoperatively
Routine postoperative clinical follow-up for 24 months
Assessment Time Points:
Preoperative Assessments:
1 month before surgery
Day of surgery
Postoperative Assessments:
1 month
3 months
6 months
9 months
12 months
18 months
24 months
Outcomes:
Primary Outcome:
Change in BMI or BMI z-score from baseline to 24 months
Secondary Outcomes:
Safety and tolerability of early semaglutide re-initiation
Changes in weight and waist circumference
Changes in cardiometabolic markers (e.g., HbA1c, lipids, blood pressure)
Tertiary Outcomes:
Changes in eating behaviors
Quality of life assessments
Adherence and persistence with medication
Rate of postoperative complications
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care following bariatric surgery. No Reinitiation of obesity optimizing medications.
Early Reinitiation of semaglutide at 2 weeks after bariatric surgery per standard titration starting at 0.25 mg weekly and titrating to 2.4 mg weekly
Drug: Semaglutide 2.4 mg
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.
Also known as: Wegovy
Percent Body Mass Index
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.
Time frame: From enrollment to the end of the end of the study at 24 months
Modified percent time in range
Modified Percent Time in Range (TIR) is defined as the proportion of time a participant's blood glucose levels fall within the target glycemic range of 70-140 mg/dL, as measured by continuous glucose monitoring (CGM). This narrower range is selected to reflect more stringent glycemic control goals for youth with type 2 diabetes and to better capture early intervention effects on glucose regulation. TIR is expressed as a percentage of total monitored time. Calculation: TIR (%) = (Time within 70-140 mg/dL / Total monitored time) × 100 Data on time above range (TAR; \>140 mg/dL) and time below range (TBR; \<70 mg/dL) may also be collected as exploratory or secondary metrics. Type: Continuous Units: Percent (%)
Time frame: From enrollment to the end of the study period at 24 months
Eating in the absence of hunger
This outcome measures Eating in the Absence of Hunger (EAH) using a validated laboratory-based protocol designed to assess non-homeostatic eating behaviors in children and adolescents. EAH is defined as the intake of palatable foods when an individual is physically satiated, capturing susceptibility to external food cues and emotional or hedonic eating. During the lab experiment, participants are first provided with a standardized meal designed to achieve satiety. Following a brief rest period, participants are then given free access to a variety of palatable snack foods (e.g., chips, cookies, candy) in a controlled setting, with no time pressure and no encouragement to eat. The total caloric intake during this period is measured and recorded. Type: Continuous Units: Kilocalories (kcal) consumed during the EAH protocol
Time frame: Month 24 compared to baseline
Plan to share: Yes — Individual Participant Data that underlie the results reported in this study will be shared after de-identification. This includes all data collected at the individual level for primary, secondary, and exploratory outcomes. Types of IPD to be Shared: De-identified demographic and baseline characteristics Primary outcome data Secondary outcome data Adherence and safety data How to Request Access: Researchers should contact the principal investigator through the University of Southern California institutional repository. Specific details on data availability and request procedures will be posted with the publication of study findings.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD will be made available no later than 24 months after study completion (defined as final follow-up visit for the last participant) and will remain available for up to 5 years following publication of the primary results.
Access criteria: Data will be shared with qualified researchers upon request for the purpose of academic research. Requests must include a methodologically sound proposal and will be reviewed by the study's data access committee. All requestors must agree to a data use agreement to ensure participant confidentiality and appropriate data handling.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2030, 50 months later.
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Studies of the drug tested here: Semaglutide
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