Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth
Launched by CHILDREN'S HOSPITAL LOS ANGELES · Apr 11, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether it’s safe and effective for young people with severe obesity to start taking a medication called semaglutide again just two weeks after having weight loss surgery, known as sleeve gastrectomy. The trial will involve 150 participants aged 12 to 18 who have been using semaglutide for at least three months before their surgery. They will be divided into two groups: one will receive weekly doses of semaglutide for 24 months, while the other will get standard care without medication. The researchers want to see if starting semaglutide earlier helps improve weight loss, heart health, and eating habits compared to standard care.
To be eligible for this trial, participants must have severe obesity and be undergoing weight loss surgery at Children’s Hospital Los Angeles. They should be willing to have blood tests and share health information for research purposes. It’s important to note that those with certain medical conditions, like type 1 diabetes or other specific syndromes, won’t be able to participate. The trial is not yet recruiting, but it aims to provide valuable insights into the best ways to support young people in their weight loss journey after surgery.
Gender
ALL
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.
About Children's Hospital Los Angeles
Children's Hospital Los Angeles (CHLA) is a renowned pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative research and clinical care. As a leading clinical trial sponsor, CHLA is committed to conducting high-quality, ethical research that addresses critical pediatric health issues. With a focus on translating scientific discoveries into effective treatments, CHLA collaborates with multidisciplinary teams and leverages state-of-the-art facilities to support a wide range of clinical trials. Their mission is to enhance the understanding and treatment of childhood diseases, ultimately improving outcomes for young patients and their families.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Alaina Vidmar, MD
Principal Investigator
Children's Hospital Los Angeles
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported