Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth

ConditionsPediatric Obesity Metabolic and Bariatric Surgery Semaglutide

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age12-18

SponsorChildren's Hospital Los Angeles

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) 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Standard CareNo intervention 0 interventions

Group B: Early reinitiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

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Children's Hospital Los Angeles

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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