Recruiting
Phase 3

Semaglutide

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06934655

Conditions

Pediatric Obesity

Metabolic and Bariatric Surgery

Semaglutide

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Semaglutide 2.4 mg

Study Details

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

Metabolic and Bariatric Surgery

Semaglutide

Study ID

NCT06934655

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Nov 1, 2033

Anticipated

Primary completion date

Nov 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard Care

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

experimental: Early reinitiation

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

Interventions

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.

Primary outcome measure

  • Percent Body Mass Index [ Time Frame: From enrollment to the end of the end of the study at 24 months ]

Central Contacts and Locations

Central contacts

Alaina P Vidmar, MD

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

Kamran Samakar, MD

Kamran.Samakar@med.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Alaina Alaina Vidmar, MD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2026-09-02.