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CompletedPhase 2Results posted

Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

100

actual

Study population

Obesity / overweight

Key I/E criterion

Age 12-17

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 IDNCT02496611
Org study ID1505M72081

Timeline

Milestones

Study first posted2015-07-14estimated
Primary completion2020-08-14actual
Study completion2020-08-14actual
Last update posted2022-01-03actual
Results first posted2022-01-03actual
Study start2015-12 (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age17 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
12-17 years old

Exclusion criteria

Type 1 or 2 diabetes mellitus
Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
Previous bariatric surgery
If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months
History of treatment with growth hormone
Neurodevelopmental disorder severe enough to impair ability to comply with study protocol
Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse
Females: currently pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study
Tobacco use
Liver/renal dysfunction
ALT or AST >2 times the upper limit of normal
Bicarbonate <18 mmol/L
Creatinine >1.2 mg/dL
History of pancreatitis
Personal- and/or family history of medullary thyroid carcinoma
Personal- and/or family history of multiple endocrine neoplasia type 2
Calcitonin level >50 ng/L
Bulimia nervosa
Neurological disorder
Hypothalamic obesity
Obesity associated with genetic disorder (monogenetic obesity)
Hyperthyroidism or uncontrolled hypothyroidism
History of suicide attempt
History of suicidal ideation or self-harm within the past year
History of cholelithiasis

Endpoints (1)

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

1 endpoint
Primary/protocol endpoint

Body Mass Index

Time frame:52 weeks

BMI, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage (body mass index)95% CI
Weight Loss Maintenance Without Pharmacotherapy10.1
Weight Loss Maintenance With Pharmacotherapy4.6

Publications (2)

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.