Status:
COMPLETED
Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Status Post Sleeve Gastrectomy
Eligibility:
All Genders
12-20 years
Phase:
PHASE2
Brief 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 thi...
Detailed Description
Study Description: This trial 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 g...
Eligibility Criteria
Inclusion
- 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
- EXCLUSION CRITERIA:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- Weight of more than 450 lbs. (because Dual-Energy X-ray Absorptiometry (DXA) scanning cannot be done in those exceeding this weight)
- Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance such as a DPPIV inhibitor
- 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
- History of recurrent pancreatitis (greater than 2 episodes)
- History of chronic kidney disease (eGFR \<60)
- History of gastroparesis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- 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.
- Known or suspected allergy to trial medication, excipients, or related products
- Treatment with another investigational drug or other experimental intervention within 3 months prior to enrollment in this trial
- 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
Exclusion
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04883346
Start Date
June 21 2021
End Date
April 30 2024
Last Update
November 20 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892