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CompletedPhase 2Results posted

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

NCT IDNCT04883346
Org study ID10000241
Secondary ID000241-CHNIH Clinical Center

Timeline

Milestones

Study first posted2021-05-12actual
Study start2021-06-21actual
Primary completion2024-03-15actual
Study completion2024-04-30actual
Last update posted2024-11-20actual
Results first posted2024-11-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age20 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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 endpoints
Primary/registry result

Cohen's d (the Standardized Mean Difference)

Time frame:16 weeks

BMI, change

change from baseline, improvement

Posted result

GroupValue (number), cohen's d95% CI
Liraglutide2.1451.72 – 2.55
Primary/protocol endpoint

Cohen's d (the Standardized Mean Difference)

Time frame:16 weeks

BMI, change

change from baseline, improvement

Secondary/registry result

Change in Fat Mass

Time frame:16 weeks

Total fat mass

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Liraglutide-3.2
Mean Difference (Final Values)-3.2p<0.001t-test, 2 sided
Secondary/registry result

Change in BMI

Time frame:16 weeks

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kg/m295% CI
Liraglutide-1.7
Mean Difference (Final Values)-1.7p<0.001t-test, 2 sided
Secondary/registry result

Change in Body Mass Index Z-score

Time frame:16 weeks

BMI SDS, change

change from baseline, improvement

Posted result

GroupValue (mean), Z-score95% CI
Liraglutide-0.2
Mean Difference (Final Values)-0.2p<0.001t-test, 2 sided
Secondary/registry result

Change in Body Weight

Time frame:16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Liraglutide-4.4
Mean Difference (Final Values)-4.4p<0.001t-test, 2 sided
Secondary/protocol endpoint

Change in Fat Mass

Time frame:16 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:16 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index Z-score

Time frame:16 weeks

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.