Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

NCT06934655 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: APP-IP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Semaglutide; Metabolic and Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of the end of the study at 24 months

Secondary Outcomes (1)

• Modified percent time in range

  From enrollment to the end of the study period at 24 months

Other Outcomes (1)

• Eating in the absence of hunger

  Month 24 compared to baseline

Study Arms (2)

Standard Care

NO INTERVENTION

Standard of care following bariatric surgery. No Reinitiation of obesity optimizing medications.

Early reinitiation

EXPERIMENTAL

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

Interventions

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.

Also known as: Wegovy

Early reinitiation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alaina Vidmar, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaina P Vidmar, MD

CONTACT

530-383-1732; avidmar@chla.usc.edu

Kamran Samakar, MD

CONTACT

Kamran.Samakar@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Director of Obesity Medicine and Bariatric Surgery

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 18, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2033
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)