Pediatric ObesityPhase 3NCT06934655
Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth
A Phase 3 study testing Semaglutide 2.4 mg in people with Pediatric Obesity and Metabolic and Bariatric Surgery, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pediatric Obesity, Metabolic and Bariatric Surgery, Semaglutide
- What is being tested?
- Semaglutide 2.4 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Nov 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kamran Samakar, MD contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Alaina Alaina Vidmar, MD
About this study
Official title: Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth: A Randomized Clinical 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.
Read the 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
- Being tested
- Semaglutide 2.4 mg
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mgDrug
Also called Wegovy
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Semaglutide 2.4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the end of the study at 24 months
Secondary outcomes (1)
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 (%)
Measured: From enrollment to the end of the study period at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaina P. Vidmar, MD, Children's Hospital Los Angeles
- Investigators
- Alaina Vidmar, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934655
- Sponsor's protocol ID
- CHLA-26-00073
- Other IDs
- 1R01DK144100-01A1
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data that underlie the results reported in this study will be shared after de-identification. This includes all data collected at the individual level for primary, secondary, and exploratory outcomes. Types of IPD to be Shared: De-identified demographic and baseline characteristics Primary outcome data Secondary outcome data Adherence and safety data How to Request Access: Researchers should contact the principal investigator through the University of Southern California institutional repository. Specific details on data availability and request procedures will be posted with the publication of study findings.