Cohen's d (the Standardized Mean Difference)
| Group | Value (cohen's d) |
|---|---|
| Liraglutide | 2.145 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy
NCT0488334621 Jun 2021 to 30 Apr 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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....
Experimental
Liraglutide
Treated with Liraglutide
Outcomes the sponsor listed as primary.
Cohen's d (the Standardized Mean Difference)
Time frame · 16 weeks
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.
Change in Fat Mass
Time frame · 16 weeks
Change in fat mass (in kg) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing
Change in BMI
Time frame · 16 weeks
The change in BMI (kg/m2) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing
Change in Body Mass Index Z-score
Time frame · 16 weeks
The change in Body Mass Index Z-score (standard deviation score for age and sex based on US Centers for Disease Control Standards from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing. Please see description for Body Mass Index Z-score in baseline information section for more details on calculation of Body Mass Index Z-score.
Change in Body Weight
Time frame · 16 weeks
The change in body weight (kg) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (cohen's d) |
|---|---|
| Liraglutide | 2.145 |
| Group | Value (kg) | Spread |
|---|---|---|
| Liraglutide | -3.2 | 3.4 |
| Group | Value (kg/m2) | Spread |
|---|---|---|
| Liraglutide | -1.7 | 1.5 |
| Group | Value (Z-score) | Spread |
|---|---|---|
| Liraglutide | -0.2 | 0.1 |
| Group | Value (kg) | Spread |
|---|---|---|
| Liraglutide | -4.4 | 4.4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideTreated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose was initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated. | 0 / 34 | 0 / 34 | 19 / 34 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2020
Kelly et al. 2020The New England journal of medicinecited by 520
PMID 32233338DOI 10.1056/nejmoa1916038PUB-32233338
Indexing hint: Randomized controlled trial · 2015
Pi-Sunyer et al. 2015The New England journal of medicinecited by 1,954
PMID 26132939DOI 10.1056/nejmoa1411892PUB-26132939
Who could join, as posted.
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