Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth
Early Reinitiation of Semaglutide Post-Sleeve Gastrectomy in Youth: A Randomized Clinical Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 18 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests restarting semaglutide 2 weeks after sleeve surgery, which removes part of the stomach for weight loss. It is for teens ages 12 to 18 with severe obesity who have taken semaglutide for at least 3 months before surgery. Teens will be assigned by chance to weekly semaglutide or usual care without weight-loss medicine for 24 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 12 to 18 years old.
- Have reached at least Tanner stage 3, a middle stage of puberty.
- Have severe obesity: a body mass index (BMI) over 35, or at least 140% of the 95th percentile for age and sex.
- Be having a first weight-loss surgery through the children's weight-loss surgery program at Children's Hospital Los Angeles.
- Be willing to have blood drawn at set times before and after surgery.
- Be willing to have health information stored in a study database.
- Have a caregiver who agrees to participation.
- Have taken semaglutide 2.4 mg weekly for at least 3 months before surgery as part of regular obesity care, separate from surgery plans.
Who can't join
- Have been diagnosed with type 1 diabetes.
- Take medicines that affect body fat or muscle, prevent weight loss, or cause weight gain, such as prednisone.
- Have a condition that may affect recovery after surgery, such as Cushing syndrome, Down syndrome, or Prader-Willi syndrome.
- Have serious health problems that require frequent hospital stays, may interrupt medicines, or make restarting semaglutide early unsafe.
- Be unwilling to follow the study's eligibility rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
CA
- Children's Hospital Los Angeles · Los Angeles, CA 90027Alaina Alaina Vidmar, MD · Principal investigatorMore trials in Los Angeles