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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
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
34
actual
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
—
Primary endpoint
•BMI, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Male or female, 12-20.999 years at screening visit
2. 12 months or more status-post vertical sleeve gastrectomy with a maximum of 10 years after surgery
3. BMI 30 kg/m2 or greater than or equal to 95th percentile for age and sex
4. In good general health as evidenced by medical history
5. Ability to take subcutaneous medication and be willing to adhere to the daily subcutaneous liraglutide regimen
6. Ability to provide consent/assent before any trial-related activities as required per protocol
7. 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:
1. 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
2. Weight of more than 450 lbs. (because Dual-Energy X-ray Absorptiometry (DXA) scanning cannot be done in those exceeding this weight)
3. Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance such as a DPPIV inhibitor
4. Weight loss of more than 3% of body weight in the past 2 months
5. Current pregnancy, desire to become pregnant within study period, current lactation or, if sexually active, not willing to use adequate contraceptive measures
6. History of recurrent pancreatitis (greater than 2 episodes)
7. History of chronic kidney disease (eGFR <60)
8. History of gastroparesis
9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
10. History of prior metabolic and bariatric surgery other than vertical sleeve gastrectomy
11. Current or prior use of any GLP-1 agonist medication during the 6 months before screening, including liraglutide.
12. Known or suspected allergy to trial medication, excipients, or related products
13. Treatment with another investigational drug or other experimental intervention within 3 months prior to enrollment in this trial
14. 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
15. Suicidal ideation type 4 or 5, history of past suicide attempt, and suicidal behavior in the past month
16. Presence of a major medical illness not listed above
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Weight & body composition
10 endpointsCohen's d (the Standardized Mean Difference)
Time frame:16 weeks
BMI, change
change from baseline, improvement
Posted result
| Group | Value (number), cohen's d | 95% CI |
|---|---|---|
| Liraglutide | 2.145 | 1.72 – 2.55 |
Cohen's d (the Standardized Mean Difference)
Time frame:16 weeks
BMI, change
change from baseline, improvement
Change in Fat Mass
Time frame:16 weeks
Total fat mass
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Liraglutide | -3.2 | — |
Change in BMI
Time frame:16 weeks
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), kg/m2 | 95% CI |
|---|---|---|
| Liraglutide | -1.7 | — |
Change in Body Mass Index Z-score
Time frame:16 weeks
BMI SDS, change
change from baseline, improvement
Posted result
| Group | Value (mean), Z-score | 95% CI |
|---|---|---|
| Liraglutide | -0.2 | — |
Change in Body Weight
Time frame:16 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Liraglutide | -4.4 | — |
Change in Fat Mass
Time frame:16 weeks
Total fat mass
change from baseline, improvement
Change in BMI
Time frame:16 weeks
BMI, change
change from baseline, improvement
Change in Body Mass Index Z-score
Time frame:16 weeks
BMI SDS, change
change from baseline, improvement
Change in Body Weight
Time frame:16 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The New England journal of medicine2020 May 28PMID32233338doi:10.1056/NEJMoa1916038via CT.gov background
- The New England journal of medicine2016 Jan 14PMID26544725doi:10.1056/NEJMoa1506699via CT.gov background
- The New England journal of medicine2015 Jul 2PMID26132939doi:10.1056/NEJMoa1411892via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.