NCT04883346CompletedPhase 2
Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy
Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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....
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 11 May 2021
- Start date
- 21 Jun 2021
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Diseases
- Obesity
- NCT number
- NCT04883346
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 34
- From 21 Jun 2021 to the primary completion date, 15 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent (within 3 months of start of study drug initiation) use of weight loss medications such as phentermine, topiramate, lisdexamfetamine (prescribed specifically for weight loss; when prescribed for ADHD and dose is stable for last 3 months this medication will be allowed), orlistat, and naltrexone HCl/bupropion HCl, or liraglutide
- History of prior metabolic and bariatric surgery other than vertical sleeve gastrectomy
- Current or prior use of any GLP-1 agonist medication during the 6 months before screening, including liraglutide.
- Treatment with another investigational drug or other experimental intervention within 3 months prior to enrollment in this trial
Other illness
- History of recurrent pancreatitis (greater than 2 episodes)
- History of gastroparesis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Known or suspected allergy to trial medication, excipients, or related products
- Individuals who have current substance abuse or a DSM 5 Axis I psychiatric disorder or DSM Axis II Mental Retardation diagnosis that in the opinion of the investigators would impede competence, compliance, or participation in the study
- Suicidal ideation type 4 or 5, history of past suicide attempt, and suicidal behavior in the past month
- Presence of a major medical illness not listed above
Lab values
- Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance such as a DPPIV inhibitor
- History of chronic kidney disease (eGFR \<60)
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Weight of more than 450 lbs. (because Dual-Energy X-ray Absorptiometry (DXA) scanning cannot be done in those exceeding this weight)
- Weight loss of more than 3% of body weight in the past 2 months
- Current pregnancy, desire to become pregnant within study period, current lactation or, if sexually active, not willing to use adequate contraceptive measures
Criteria the registry did not label
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, 12-20.999 years at screening visit
- 12 months or more status-post vertical sleeve gastrectomy with a maximum of 10 years after surgery
- BMI 30 kg/m2 or greater than or equal to 95th percentile for age and sex
- In good general health as evidenced by medical history
- Ability to take subcutaneous medication and be willing to adhere to the daily subcutaneous liraglutide regimen
- Ability to provide consent/assent before any trial-related activities as required per protocol
- Stated availability for the duration of the study
Age in the registry: 12 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.