Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

Phase 3

Not yet recruiting

• Conditions: Pediatric Obesity; Metabolic and Bariatric Surgery; Semaglutide
• Interventions: Drug: Semaglutide 2.4 mg

• Registration Number: NCT06934655
• Lead Sponsor: Children's Hospital Los Angeles

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

Study Timeline

• Study First Submitted: 2025-03-24
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-11-01
• Primary Completion: 2030-11-01
• Study Completion: 2033-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early reinitiation	Semaglutide 2.4 mg	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%)

Trial Locations

Locations (1)

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