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NCT04883346 · ClinicalTrials.gov registry record · Phase 2
Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy
A Phase 2 study of Obesity and Status Post Sleeve Gastrectomy, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04883346: Completed Phase 2 study of Obesity and Status Post Sleeve Gastrectomy, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT04883346 is a Phase 2 study of Obesity and Status Post Sleeve Gastrectomy that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 34 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04883346, a Phase 2 study of Obesity and Status Post Sleeve Gastrectomy, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
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....
Primary Outcome
The change in BMI (kg/m2) measured from the baseline visit to the week 16 visit was used to inform a power calculation for a subsequent randomized controlled trial, assuming no change in BMI for the placebo group and the change in BMI that was found in this study at 16 weeks for the liraglutide group. There is no statistical analysis associated with this result.
Conditions Studied
Interventions
- DRUG Liraglutide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT04883346 record still lists
NCT04883346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Liraglutide is the first listed.
NCT04883346 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04883346 about?
NCT04883346 is a clinical study titled "Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy". 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 he...
What is the current status of trial NCT04883346?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2021-06-21. Estimated completion is 2024-04-30.
What conditions does trial NCT04883346 study?
This clinical trial studies the following conditions: Obesity, Status Post Sleeve Gastrectomy.
What interventions are being tested in trial NCT04883346?
The interventions under investigation include: Liraglutide (DRUG).
Who is sponsoring clinical trial NCT04883346?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04883346 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04883346's enrollment target sits among peer trials
34 829th of 1053 higher than 221 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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