Pediatric Obesity, Metabolic and Bariatric Surgery, Semaglutide
Conditions
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 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.
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: 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
Interventions
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.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Body Mass Index | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified percent time in range | From enrollment to the end of the study period at 24 months | 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 (%) |
Countries
United States
Contacts
CONTACTAlaina P Vidmar, MD
CONTACTKamran Samakar, MD
PRINCIPAL_INVESTIGATORAlaina Vidmar, MD
Children's Hospital Los Angeles
Outcome results
None listed