Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04883346|
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : June 24, 2022
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.
To learn if liraglutide can help adolescents who still have obesity 1 year or more after vertical sleeve gastrectomy lose additional weight.
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.
Participants will be screened with:
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 7 study visits....
|Condition or disease||Intervention/treatment||Phase|
|Obesity Status Post Sleeve Gastrectomy||Drug: Liraglutide||Phase 2|
This is an open-label Phase II non-randomized pilot study conducted at the NIH Clinical Center to investigate the efficacy of daily subcutaneous injection of liraglutide, a glucagon-like peptide-1 (GLP1) analogue to promote reduction of body mass index (BMI) in adolescents who continue to have obesity (BMI greater than or equal to 30 or BMI greater than or equal to 95th percentile for age and sex) 1 year or more after vertical sleeve gastrectomy (SG). We hypothesize that administration of liraglutide will be associated with reduction in BMI in such adolescents.
The Primary objective is to determine the effect size for the change in BMI of liraglutide 3.0 mg daily subcutaneously at 16 weeks in adolescents who have obesity after SG, in order to use the observed changes to determine the sample size of a subsequent randomized, controlled investigation. Up to 50 adolescents and young adults (age 12-20) will be recruited to treat up to 40 with liraglutide for 16 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study|
|Actual Study Start Date :||June 21, 2021|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||October 1, 2023|
Treated with Liraglutide
Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
- Change in BMI [ Time Frame: 16 weeks ]The change in BMI (kg/m2) measured from the baseline visit to the week 16 visit will be used to inform a power calculation for a subsequent trial.
- Change in Fat Mass [ Time Frame: 16 weeks ]Change in fat mass (in kg) from baseline to the week 16 visit
- Change in BMI [ Time Frame: 16 weeks ]The change in BMI (kg/m2) from baseline to the week 16 visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883346
|Contact: Anna Zenno, M.D.||(301) firstname.lastname@example.org|
|Contact: Jack A Yanovski, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Jack A Yanovski, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|