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Clinical trialNCT04883346CompletedPhase 2Interventional

Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Enrollment34ObesityStatus Post Sleeve Gastrectomy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: Metabolic Bariatric Surgery, including a surgery called vertical sleeve gastrectomy, is the most effective weight loss treatment for severe obesity. However, many adolescents who have this surgery still have obesity 1 year later or regain weight. Researchers want to see if a drug can help. Objective: To learn if liraglutide can help adolescents who still have obesity 1 year or more after vertical sleeve gastrectomy lose additional weight. Eligibility: Healthy adolescents ages 12-20.99 years who are 1-10 years post vertical sleeve gastrectomy and have a BMI of 30 kg/m2 or \>=95th percentile for age and sex. Design: Participants will be screened with: Medical history Physical exam Questionnaires about their mood and feelings about their weight Blood and urine tests Nutrition counseling. They will keep a diet log. A test where they view and respond to pictures of food Wrist accelerometer set-up. They will wear an accelerometer (a device like a watch) on their wrist for 14 days. It will measure their physical activity. Some screening tests will be repeated during the study. Participants will have an oral glucose tolerance test. They will ingest a sweet liquid. Blood samples will be taken. Participants will take liraglutide daily for 16 weeks. They will learn how to inject it under their skin. Participants will have a body scan to measure muscle and fat. Participants will be invited to eat as much as they want at a buffet meal at NIH. How much food they eat will be calculated. They will assess their appetite and mood before and after the meal. Participation will last for 7 months. Participants will have up to 7 study visits....

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Jack A Yanovski, M.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
21 Jun 2021
Primary completion
15 Mar 2024
Completion
30 Apr 2024
Last update posted
20 Nov 2024
Registered enrollment
34
Registry id
NCT04883346

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.