Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT06934655
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Metabolic and Bariatric Surgery
  • Pediatric Obesity
  • Semaglutide

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2030
Completion
Nov 1, 2033

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CA

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